TECHNICAL FIELD
[001] The present invention generally relates to the field of assessment methodologies and
more particularly relates to assessment of quality management system (QMS) auditing
towards digitization and implementation.
BACKGROUND OF INVENTION
[002] The following description includes information that may be useful in understanding the
present invention. It is not an admission that any of the information provided herein is
prior art or relevant to the presently claimed invention, or that any publication
specifically or implicitly referenced is prior art.
[003] With the start of the fourth industrial revolution or Industry 4.0 (I4.0), the principles of
the I4.0 has been influenced all cross domains of the manufacturing industry. Further,
the quality domain of the manufacturing industry is greatly benefited by the
implementation of I4.0 and has emerged as a new era as Quality 4.0 (Q4.0).
[004] Many digital technologies have been researched to get insights related to the benefits
and challenges associated with use of I4.0 or Q4.0 within the manufacturing industries.
However, there is still room for monitoring the digital technologies’ impact on product
lifecycle regulatory compliance. In the context of digitization efforts in the
manufacturing sector, many countries depict high readiness while certain countries are
depicting a slow-paced digital readiness. The reason being, manufacturers are still not
aware or are lacking maturity in terms of understanding the need of digitization in the
organisation. Self-assessment/ auditing of the organisation shall provide insights on
areas where digital adoption is necessary. In this regard, quality management plays
crucial role. Quality 4.0 being a relatively new concept, poses many challenges for the
industries as they find it difficult to assess whether they are ready for implementation
of Quality 4.0 or not. Many models of assessment are available, but most of the do not
assess Quality 4.0 from the delivery excellence perspective. In delivery excellence, a
dedicated quality department manages quality and that is accomplished through audits,
process monitoring, conformance of the product with standards. The industry’s
digitization roadmap should begin with an assessment of the industry's digital maturity
level which is severely lacking.
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[005] There is therefore a need for a maturity model capable of assessing the digital readiness
along with functions of quality management in delivery excellence.
OBJECT OF THE INVENTION
[006] An object of the invention is to assess an organization’s maturity towards digitalization
of QMS, during audits resulting in the identification of gaps in both digitization and
QMS implementation.
SUMMARY OF THE INVENTION
[007] The present disclosure overcomes one or more shortcomings of the prior art and
provides additional advantages. Embodiments and aspects of the disclosure described
in detail herein are considered a part of the claimed disclosure.
[008] In one non-limiting embodiment of the present disclosure, an assessment method for
quality management system (QMS) auditing is disclosed. In one aspect, the QMS
comprises a plurality of clauses corresponding to one or more quality standards to be
complied by an entity. The method comprises identifying, from the plurality of clauses,
one or more clauses to be audited. In one aspect, the one or more clauses are associated
with a quality standard of the one or more quality standards. Further, for a clause of the
identified one or more clauses, the method further comprises calculating a score at each
stage of a plurality of stages of auditing. In one aspect, the score at each stage of
auditing is calculated based on at least one of: a level of understanding of scope of the
clause, a level of implementation of the clause, a level of establishment of standard
operating procedure (SOP) for the clause, a level of identification of at least one of:
quality parameters and entity parameters for the clause, and a level of digitization of
each of the entity parameters for the clause. Based on the calculated score at each stage
of auditing for each of the one or more clauses, the method further comprises
performing at least one of: determining whether the entity is compliant with the one or
more quality standards and calculating a comprehensive score for the one or more
quality standards indicating a level of digitization of the QMS.
4
[009] In another non-limiting embodiment of the present disclosure, each clause comprises
one or more sub-clauses.
[010] In yet another non-limiting embodiment of the present disclosure, calculating a score
at each stage of a plurality of stages of auditing further comprises calculating a score
(S) at first stage of the plurality of stages of auditing based on a level of understanding
of the clause and a level of implementation of the clause. The method further comprises
calculating a score (I) at second stage of the plurality of stages of the auditing based on
a level of establishment of standard operating procedure (SOP) for the clause and the
level of identification of at least one of: quality parameters and entity parameters for
the clause and calculating a first cumulative score based on the score calculated at the
first stage and the second stage.
[011] In yet another non-limiting embodiment of the present disclosure, the method further
comprises further comprises calculating an intermediate score corresponding to
subsequent stages of auditing based on the level of digitization of the entity parameter.
In one aspect, the intermediate score is calculated based on a level of digitization in at
least one of: sensing of the entity parameter, storing the entity parameter, making
decisions associated with the sensed and stored entity parameter, taking actions on the
sensed and stored entity parameter and presenting one or more evidence documents
presented to an auditor.
[012] In yet another non-limiting embodiment of the present disclosure, the method further
comprises calculating a digitization score for the entity based on the level of digitization
achieved for each of the entity parameters.
[013] In yet another non-limiting embodiment of the present disclosure, the method further
comprises calculating a second cumulative score corresponding to the level of
digitization of the one or more sub-clauses of each clause.
[014] In yet another non-limiting embodiment of the present disclosure, the method further
comprises calculating an overall score for each clause of the one or more clauses based
on the first cumulative score and the second cumulative score.
[015] In yet another non-limiting embodiment of the present disclosure, calculating the
comprehensive score further comprises calculating the comprehensive score for each
5
quality standard based on the overall score of each clause of the one or more clauses
associated with each quality standard.
[016] In yet another non-limiting embodiment of the present disclosure, a computing device
for assessing quality management system (QMS) auditing is disclosed. In one aspect,
the QMS comprises a plurality of clauses corresponding to one or more quality
standards to be complied by an entity. The computing device comprises a memory and
a processor operatively and communicatively coupled to the memory. In one aspect,
the processor is configured to identify, from the plurality of clauses, one or more clauses
to be audited. In one aspect, the one or more clauses are associated with a quality
standard of the one or more quality standards. For a clause of the identified one or more
clauses, the processor is further configured to calculate a score at each stage of a
plurality of stages of auditing. In one aspect the score at each stage of auditing is
calculated based on at least one of: a level of understanding of scope of the clause, a
level of implementation of the clause, a level of establishment of standard operating
procedure (SOP) for the clause, a level of identification of at least one of: quality
parameters and entity parameters for the clause, and a level of digitization of each of
the entity parameters for the clause. Based on the calculated score at each stage of
auditing for each of the one or more clauses, the processor is further configured to
perform at least one of: determine whether the entity is compliant with the one or more
quality standards and calculate a comprehensive score for the one or more quality
standards indicating a level of digitization of the QMS.
[017] In yet another non-limiting embodiment of the present disclosure, to calculate a score
at each stage of a plurality of stages of auditing, the processor is further configured to
calculate a score (S) at first stage of the plurality of stages of auditing based on a level
of understanding of the clause and a level of implementation of the clause. The
processor is further configured to calculate a score (I) at second stage of the plurality
of stages of the auditing based on a level of establishment of standard operating
procedure (SOP) for the clause and the level of identification of at least one of: quality
parameters and entity parameters for the clause and the processor is further configured
to calculate a first cumulative score based on the score calculated at the first stage and
the second stage.
6
[018] In yet another non-limiting embodiment of the present disclosure, the processor is
further configured to calculate an intermediate score corresponding to subsequent
stages of auditing based on the level of digitization of the entity parameter. In one
aspect, the intermediate score is calculated based on a level of digitization in at least
one of: sensing of the entity parameter, storing the entity parameter, making decisions
associated with the sensed and stored entity parameter, taking actions on the sensed and
stored entity parameter and presenting one or more evidence documents presented to
an auditor.
[019] In yet another non-limiting embodiment of the present disclosure, the processor is
further configured to calculate a digitization score for the entity based on the level of
digitization achieved for each of the entity parameters.
[020] In yet another non-limiting embodiment of the present disclosure, the processor is
further configured to calculate a second cumulative score corresponding to the level of
digitization of the one or more sub-clauses of each clause.
[021] In yet another non-limiting embodiment of the present disclosure, the processor is
further configured to calculate an overall score for each clause of the one or more
clauses based on the first cumulative score and second cumulative score.
[022] In yet another non-limiting embodiment of the present disclosure, to calculate the
comprehensive score, the processor is further configured to calculate the
comprehensive score for each quality standard based on the overall score of each clause
of the one or more clauses associated with each quality standard.
[023] The foregoing summary is illustrative only and is not intended to be in any way limiting.
In addition to the illustrative aspects, embodiments, and features described above,
further aspects, embodiments, and features will become apparent by reference to the
drawings and the following detailed description.
BRIEF DESCRIPTION OF DRAWINGS
[024] The features, nature, and advantages of the present disclosure will become more
apparent from the detailed description set forth below when taken in conjunction with
the drawings in which like reference characters identify correspondingly throughout.
7
Some embodiments of system and/or methods in accordance with embodiments of the
present subject matter are now described, by way of example only, and with reference
to the accompanying Figs., in which:
[025] Figures 1A-1D depict exemplary environments 100A-100D of a computing device for
assessing quality management system (QMS) auditing in accordance with an
embodiment of the present disclosure,
[026] Figure 2 depicts a block diagram 200 of a computing device for assessing quality
management system (QMS) auditing in accordance with an embodiment of the present
disclosure, and
[027] Figure 3 depicts, by way of a flow chart, a method 300 for assessing quality
management system (QMS) auditing in accordance with an embodiment of the present
disclosure.
[028] It should be appreciated by those skilled in the art that any block diagrams herein
represent conceptual views of illustrative systems embodying the principles of the
present subject matter. Similarly, it will be appreciated that any flow charts, flow
diagrams, state transition diagrams, pseudo code, and the like represent various
processes which may be substantially represented in a computer readable medium and
executed by a computer or processor, whether or not such computer or processor is
explicitly shown.
DETAILED DESCRIPTION
[029] The foregoing has broadly outlined the features and technical advantages of the present
disclosure in order that the detailed description of the disclosure that follows may be
better understood. It should be appreciated by those skilled in the art that the conception
and specific embodiment disclosed may be readily utilized as a basis for modifying or
designing other structures for carrying out the same purposes of the present disclosure.
[030] The novel features which are believed to be characteristic of the disclosure, both as to
its organization and method of operation, together with further objects and advantages
will be better understood from the following description when considered in connection
8
with the accompanying figures. It is to be expressly understood, however, that each of
the figures is provided for the purpose of illustration and description only and is not
intended as a definition of the limits of the present disclosure.
[031] The present disclosure is directed towards assessing an entity’s maturity towards
digitization of QMS, during audits and thereby identify gaps in both digitization and
QMS implementation. It may be noted by a skilled person that the entity may be an
industry, or an organization associated with manufacturing sector. Further, the present
disclosure provides freedom to the auditors to perform audits clause-wise and/or as per
a checklist method. A skilled person may select any audit methodology based on their
preference. In particular, the present disclosure employs a scoring-based methodology
to evaluate the quality standard compliance of the entity and the maturing of digitization
of the QMS. A detailed description of the disclosure is provided in the upcoming
paragraphs in conjunction with figures 1A-1D and 2.
[032] Figures 1A-1D depict exemplary environments 100A-100D of a computing device for
assessing quality management system (QMS) auditing in accordance with an
embodiment of the present disclosure. In particular, figure 1A depicts an exemplary
environment of a computing device 102 that performs the assessment in various stages.
The various stages illustrated in Figure 1A are listed as follows –
Stage 0 – Clause identification
Stage 1 – Scope of Clause
Stage 2 – Identify
Stage 3 – Sense parameters
Stage 4 – Network (Store)
Stage 5 – Decide
Stage 6 – Action
Stage 7 – QMS Documents and Records
However, it may be noted by a skilled person that the number of stages and the order
of implementation may vary based on the requirement.
[033] At each stage of auditing, starting from the first stage (Stage 1) till the seventh stage
(Stage 7), a score is calculated based on which it is determined whether the entity is
complying the quality standards or not and the current level of digitization of the QMS.
A detailed description of the implementation of each of the above-mentioned stages (as
9
presented in figures 1A-1D) is explained in forthcoming paragraphs in conjunction with
figure 2.
[034] Figure 2 depicts an exemplary block diagram 200 of a computing device 102 for
assessing quality QMS auditing in accordance with an embodiment of the present
disclosure. The computing device 102 comprises an I/O interface 202, a memory 204,
a processor 206 and units 208. The processor 206 may be operatively coupled to the
I/O interface 202 and the memory 204. In one exemplary embodiment, the units 208
may comprise an identification unit 210, a score calculation unit 212 and a
determination unit 214.
[035] Further, in one implementation, the processor 206 may be implemented as one or more
microprocessors, microcomputers, microcontrollers, digital signal processors, central
processing units, state machines, logic circuitries, and/or any devices that manipulate
signals based on operational instructions. Among other capabilities, the at least one
processor 206 may be configured to fetch and execute computer-readable instructions
stored in the memory 204. The I/O interface 202 may include a variety of software and
hardware interfaces, for example, a web interface, a graphical user interface, and the
like.
[036] The I/O interface 202 may include a variety of software and hardware interfaces, for
example, a web interface, a graphical user interface, and the like. The I/O interface 202
may enable the computing device 102 or specifically the processor 206 to communicate
with other components such as a network entity 216 and any other components (not
shown in figures). The I/O interface 202 may facilitate multiple communications within
a wide variety of networks and protocol types, including wired networks, for example,
LAN, cable, etc., and wireless networks, such as WLAN, cellular, or satellite.
[037] According to embodiments of present disclosure, the units 208 may comprise dedicated
hardware components like processor, microprocessor, microcontrollers, applicationspecific integrated circuit (ASIC) which interacts with each other for performing
various operations of the computing device 102. It must be understood to a person
skilled in art that the processor 206 may also perform all the functions of the units 208
according to various embodiments of the present disclosure.
10
[038] Referring back to figure 1A, at stage 0, the processor 206 may be configured to facilitate
identification of clauses for an auditor. In particular, the processor 206 may determine
for a particular quality standard, a plurality of applicable clauses and may present the
same to the auditor to allow an auditor to choose one or more clauses that are most
relevant for auditing. In one exemplary embodiment, each clause may comprise one or
more sub-clauses and the auditor, upon selection of a clause, may be presented with the
sub-clauses. In an embodiment, the auditor may be provided with set of most relevant
sub-clauses instead of all sub clauses. For instance, for a particular quality standard, the
clauses may comprise management responsibility, resource management, product
realization, general etc., and each clause may include one or more sub-clauses. For
instance, the clause “general” may include sub-clauses like roles undertaken, procedure
for documentation requirements etc. Further, for each identified clause, relevant
documents may be accessed through the network entity 212. In one exemplary
embodiment, the identification of clauses may be performed by the identification unit
210 either alone or in conjunction with the processor 206.
[039] Upon identification of the clauses, the assessment may move onto the next stage i.e.,
the first stage (Stage 1) as illustrated in figure 1A. At stage 1 of the assessment, the
scope of the clause is assessed. In particular, for assessing the scope of the clause, the
auditor may judge a level of understanding (U) and a level of implementation (I) for
each sub-clause of the one or more clauses. In one exemplary embodiment, the auditor
may judge the level of understanding (U) of each-sub clause of a clause based on
whether the sub-clause is fully understood, partially understood or not understood.
Further, in one exemplary embodiment, the auditor may judge the level of
implementation (I) of each sub-clause based on whether the sub-clause is fully
implemented, partially implemented or not implemented. Once, said exercise is
completed for each sub-clause, the processor 206 calculates a score (S) according to
equation (1) –
࢏ࢀ + ࢏ࢁ) = ܁
(1 (ࢄ/(
[040] wherein, i = 1, 2, 3,… N, denotes a number of sub-clauses for the clause and 1/X
indicates a weight associated with calculation of the score (S). It may be noted by a
skilled person that said weight may be chosen based on the clause being evaluated or
the quality standard in question. Further, in one exemplary embodiment, score
11
calculation may be performed by the score calculation unit 212 either alone or in
conjunction with the processor 206.
[041] In one exemplary embodiment, if the scope of a given sub-clause is fully understood,
the processor 206 may provide or calculate a 100% score and if the scope of the subclause is not understood, the processor 206 may calculate or provide a score of 0.
Similarly, if each sub-clause is fully implemented, the processor 206 may calculate or
provide a 100% score and if each sub-clause if not implemented at all, the processor
206 may calculate or provide a score 0. Further, if the scope of the sub-clause is partially
understood and if the sub-clause is partially implemented, the processor 206 may
calculate a score ranging between 0 to 100% based on a scoring scheme determined by
either the auditor or the computing device 102 based on an extent to which the scope
of the sub-clause is understood and an extent to which the sub-clause is implemented.
However, it may be noted by a skilled person that the scoring may be provided by the
processor 206 in an alternative manner including but not limited to an absolute value, a
grade etc.
[042] Moving on, at the second stage (Stage 2) of auditing as illustrated in figure 1B. At stage
2 of the assessment, it is assessed whether the necessary Standard Operating Procedures
(SOP), quality parameters and entity parameters are identified and established. In
accordance with an embodiment of the present disclosure, the SOP may be developed
based on the quality parameters (Qi) and entity parameters (Ei) for the process and
product. In one exemplary embodiment, the quality parameters (Qi) may comprise the
parameters which are measured as part of the quality management strategies and may
be subject to identification by the entity based on their quality objectives. Further, the
entity parameters (Ei) may include parameters such as Materials/Objects, Machine,
Human, Information, Energy and Environment and the quality parameters (Qi) may be
identified into separate entity parameters (Ei). The quality parameters (Qi) once
categorized may lead to the identification of new quality parameters (Qi) thus resulting
in modification in SOPs. For instance, for the entity parameter – Materials/Objects, new
quality parameters (Qi) may be identified, including but not limited to quality of
product, dimensions, shape etc. Hence, the quality parameters (Qi) and entity
parameters (Ei) are interdependent with SOP.
12
[043] Referring back to figure 1B, to assess whether the necessary Standard Operating
Procedures (SOP), quality parameters (Qi) and entity parameters (Ei) are identified and
established, the auditor may judge a level of establishment of SOP (P), a level of
identification of quality parameters (Qi) and a level of identification of entity
parameters (Ei). For instance, the auditor may judge the level of establishment of SOP
(P) of each-sub clause based on whether the sub-clause is fully established, partially
established or not established. In one exemplary embodiment, if the SOP is fully
established, the processor 206 may provide a 100% score and if the SOP is not
established, the processor 206 may provide a score of 0. Further, if the SOP is partially
established, the processor 206 may provide a score ranging between 0 to 100% based
on a scoring scheme determined by either the auditor or the computing device 102 based
on an extent to which the SOP is established. Further, the auditor may judge the level
of identification of quality parameters (Qi) and the level of identification of entity
parameters (Ei) of each sub-clause based on whether the quality parameters (Qi) and the
entity parameters (Ei) are identified or not identified. In one exemplary embodiment,
the processor 206 may consider a score of 100% if the quality parameters Qi) and the
entity parameters (Ei) are identified and may provide a score of zero if the quality
parameters (Qi) and the entity parameters (Ei) are not identified. However, it may be
noted by a skilled person that the scoring may be provided by the processor 206 in an
alternative manner including but not limited to an absolute value, a grade etc. Further,
the auditor may also select the entity parameters out of Materials/Objects, Machine,
Human, Information, Energy and Environment that are relevant for the particular subclause being assessed. Once, said exercise is completed for each sub-clause, the
processor 206 calculates a score (I) according to equation (2)–
࢏ࡱ + ࢏ࡽ + ࢏ࡼ) = ࡵ
(2 (ࢅ/(
[044] where, i = 1, 2, 3,… N, denotes a number of sub-clauses for the clause and 1/Y denotes
a weight associated with calculation of the score (I). However, it may be noted by a
skilled person that said weight may be chosen based on the clause being evaluated or
the quality standard in question. In an exemplary embodiment, the weights may be
equal to one another In another embodiment, the weights 1/X and 1/Y are not equal to
one another. Further, in one exemplary embodiment, score calculation may be
performed by the score calculation unit 212 either alone or in conjunction with the
processor 206.
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[045] Upon calculation of score (S) at the first stage (Stage 1) and the calculation of the score
(I) at the second stage (Stage 2), the processor 206 may calculate a first cumulative
score (So) according to equation (3) –
S0 = (S+I)/Z (3)
where, 1/Z denotes the weight associated with the first two stages (Stage 1, Stage 2) of
assessment with respect to the remaining stages (Stages 3-7) of assessment. However,
it may be noted by a skilled person that said weight may be chosen based on the clause
being evaluated or the quality standard in question or the further stages to be
implemented. Further, in one exemplary embodiment, score calculation may be
performed by the score calculation unit 212 either alone or in conjunction with the
processor 206.
[046] It may be noted by a skilled person that stages 0-2 of the assessment are input stages
where the auditor refers to standard documents as obtained from the network entity 212.
The upcoming stages 3-6 are output stages with data being output for requirements of
the quality standard. Further, the final stage, i.e., Stage 7 is used to evaluate the
generated evidence.
[047] Now, figure 1C depicts the implementation of Stages 3-7 of the assessment. At the third
stage (Stage 3) of the assessment, a level of digitization utilized in sensing each entity
parameter (Ei) is assessed. In one exemplary embodiment, the auditor may assess the
level of digitization utilized in sensing entity parameter (Ei) based on whether the
sensing of the entity parameter (Ei) is implemented or not. Further, if the sensing of the
entity parameter (Ei) is implemented, it may then be assessed whether the entity
parameter (Ei) is sensed manually, partially manually, partially automatically or
automatically. Once, the exercise is completed, the processor 206 may calculate a score
(R). In one exemplary embodiment, if the sensing of the entity parameter (Ei) is not
implemented, the processor 206 may calculate or consider the score (R) as zero. On
similar lines, if the sensing of the entity parameter (Ei) is implemented manually,
partially manually and partially digitally, the processor 206 may calculate the score (R)
as 25%, 50% and 75% respectively. Further, if the sensing of the entity parameter (Ei)
is implemented digitally, the processor 206 may calculate or consider the score (R) as
100%. However, it may be noted by a skilled person that the scoring may be provided
by the processor 206 in an alternative manner including but not limited to an absolute
14
value, a grade etc. A person skilled in the art may appreciate that the above- mentioned
scores are not fixed but may vary depending on the requirement imposed by the auditor
or operator of the computing device. Further, in one exemplary embodiment, score
calculation may be performed by the score calculation unit 212 either alone or in
conjunction with the processor 206.
[048] At the fourth stage (Stage 4) of the assessment, a level of digitization utilized in
networking or storing the sensed entity parameters (Ei) is assessed. In one exemplary
embodiment, the auditor may assess the level of digitization utilized in storing each
sensed entity parameter (Ei) based on whether the sensed entity parameter (Ei) is stored
or not. If the entity parameter is stored, it may be assessed whether the sensed entity
parameter (Ei) is stored in a paper (Physical) form or entered into a digital form (Partial
physical) or both, or the entity parameter (Ei) is triggered physically and stored digitally
(Partial digital) or stored without human intervention (Digital). Once, the exercise is
completed, the processor 206 may calculate a score (N). In one exemplary embodiment,
if the storing of the sensed entity parameter (Ei) is not implemented, the processor 206
may calculate or consider the score (N) as zero. On similar lines, if the sensed entity
parameter (Ei) is stored partially physically or partially digitally, the processor 206 may
calculate and provide a score (N) ranging between 0 to 100% based on a scoring scheme
determined by either the auditor or the computing device 102 based on an extent to
which the sensed entity parameter (Ei) is stored physically and digitally. Further, if the
sensed entity parameter (Ei) is stored both physically and digitally or fully digitally, the
processor 206 may calculate or consider the score (N) as 100%. However, it may be
noted by a skilled person that the scoring may be provided by the processor 206 in an
alternative manner including but not limited to an absolute value, a grade etc. Further,
in one exemplary embodiment, score calculation may be performed by the score
calculation unit 212 either alone or in conjunction with the processor 206.
[049] At the fifth stage (Stage 5) of the assessment, a level of digitization utilized in making
decisions associated with the sensed entity parameters (Ei) is assessed. In one
exemplary embodiment, the auditor may assess the level of digitization utilized in
making decisions associated with the sensed entity parameters (Ei) based on whether
the decision-making is implemented or not. Further, it is also assessed whether the
decisions pertaining to the sensed entity parameters (Ei) are made based on physical
15
data, digital data, partially physical data, partially digital data or both physical and
digital data. Once, the exercise is completed, the processor 206 may calculate a score
(D). In one exemplary embodiment, if the decision-making is not implemented, the
processor 206 may consider the score (D) as 0. On similar lines, if the decision-making
is implemented based either digital data or both physical and digital data, the processor
206 may consider the score (D) as 100%. On similar lines, if the decision-making is
based on partially physical data or partial digital data, the processor 206 may calculate
and provide a score (D) ranging between 0 to 100% based on a scoring scheme
determined by either the auditor or the computing device 102 based on an extent to
which the decision-making is based on partially physical data and partial digital data.
However, it may be noted by a skilled person that the scoring may be provided by the
processor 206 in an alternative manner including but not limited to an absolute value, a
grade etc. Further, in one exemplary embodiment, score calculation may be performed
by the score calculation unit 212 either alone or in conjunction with the processor 206.
[050] At the sixth stage (Stage 6) of the assessment, a level of digitization utilized in
documentation of any action that needs to be taken on the sensed entity parameters (Ei)
is assessed. In one exemplary embodiment, the auditor may assess the level of
digitization utilized in documenting the actions that need to be taken on the sensed
entity parameters (Ei) based on whether the actions to be taken are documented or not.
Further, it is also assessed whether the actions to be taken are documented physically,
partially physically, partially digitally or fully digitally or both physically and digitally.
Once, the exercise is completed, the processor 206 may calculate a score (A). In one
exemplary embodiment, if the actions to be taken are not documented, the processor
206 may consider the score (A) as 0. On similar lines, if the actions to be taken are
documented both physically and digitally or only digitally, the processor 206 may
consider the score (A) as 100%. On similar lines, if the actions to be taken are
documented either partially physically or partially digitally, the processor 206 may
calculate and provide a score (A) ranging between 0 to 100% based on a scoring scheme
determined by either the auditor or the computing device 102 based on an extent to
which the actions to be taken are documented physically and digitally. However, it
may be noted by a skilled person that the scoring may be provided by the processor 206
in an alternative manner including but not limited to an absolute value, a grade etc.
16
Further, in one exemplary embodiment, score calculation may be performed by the
score calculation unit 212 either alone or in conjunction with the processor 206.
[051] At the seventh stage (Stage 7) of the assessment, a level of digitization of the available
documents/records (evidence), essential for auditing, is assessed. In one exemplary
embodiment, the auditor may assess a level of digitization in a manner in which the
documents/records are available to an auditor based on whether the actions to be taken
are documented or not. Further, it is also assessed whether documents/records are
available or not. If the documents/records are available, whether the same are available
in a physical form, partially physical form, partially digital form or fully digital form.
Once, the exercise is completed, the processor 206 may calculate a score (C). In one
exemplary embodiment, if the documents/records are not available to an auditor, the
processor 206 may consider or calculate the score (C) as 0. On similar lines, if the
documents/records are available in both physical and digital form or only digital form,
the processor 206 may consider or calculate the score (C) as 100%. On similar lines, if
the documents/records are available in either partially physical or partially digital form,
the processor 206 may calculate and provide a score (C) ranging between 0 to 100%
based on a scoring scheme determined by either the auditor or the computing device
102 based on an extent to which the documents/records are available in physical form
and digital form. However, it may be noted by a skilled person that the scoring may be
provided by the processor 206 in an alternative manner including but not limited to an
absolute value, a grade etc. Further, in one exemplary embodiment, score calculation
may be performed by the score calculation unit 212 either alone or in conjunction with
the processor 206.
[052] Upon calculation of the scores R, N, D, A and C in stages 3-7 for a given entity
parameter, the processor 206 may calculate an intermediate score (S1k) for the given
entity parameter based on the scores obtained in stages 3-7 according to equation (4) –
(4 (5) /࡯ + ࡭ + ࡰ + ࡺ + ࡾ) = ࢑૚ࡿ
[053] In one exemplary embodiment, the intermediate score (S1k) may be an average score
for the given entity parameter and hence, the dividing factor 1/5 as depicted in equation
(4) may vary depending upon the number of stages. Further, the processor 206 may
calculate the intermediate score (S1k) for each entity parameter that has been selected
17
by the auditor and upon completion of the exercise, may calculate a digitization score
(S2k) for the entity based on the intermediate scores calculated for each of the entity
parameters according to equation (5) –
(5) (࡮) ∗ (࢔/࢑૚ࡿ ∑) = S2k
[054] where, n denotes a number of entity parameters and B denotes a weight associated with
calculation of the digitization score (S2k). However, it may be noted by a skilled person
that said weight may be chosen based on the clause being evaluated or the quality
standard in question. Further, in one exemplary embodiment, score calculation may be
performed by the score calculation unit 212 either alone or in conjunction with the
processor 206.
[055] Moving on, upon calculation of the digitization score (S2k) for all the entity parameters
(Ei) associated with a given sub-clause, the processor 206 may calculate a second
cumulative score (S2) based on the digitization scores (S2k) of all the sub-clauses within
a given clause according to equation (6) –
(6 (100 *࢔/(࢑૛ࡿ)∑ =S2
where, n denotes the number of sub-clauses. Further, in one exemplary embodiment,
score calculation may be performed by the score calculation unit 212 either alone or in
conjunction with the processor 206.
[056] Next, the processor 206 may then calculate an overall score (S3) for each clause of the
one or more clauses based on the first cumulative score (So) and second cumulative
score (S2) according to equation (7) –
S3= (S2 + S0) (7)
[057] Further, in one exemplary embodiment, score calculation may be performed by the
score calculation unit 212 either alone or in conjunction with the processor 206.
[058] At last, the processor 206 may calculate a comprehensive score (S4) for the particular
quality standard based on the overall score (S3) of all the clauses pertaining to the
quality standard such that the comprehensive score (S4) indicates a level of digitization
of the QMS. The comprehensive score (S4) may be calculated by the processor 206
according to equation (8) –
૜ࡿ)∑) = S4
(8) ∗ ૚૙૙ (࢔/(
18
where, n indicate the number of clauses. Further, in one exemplary embodiment, score
calculation may be performed by the score calculation unit 212 either alone or in
conjunction with the processor 206.
[059] Based on the calculated scores at each stage and the comprehensive score (S4), the
processor 206 may determine whether the entity is compliant with a particular quality
standard or not and may also be able to determine a digitization readiness of the QMS.
In one exemplary embodiment, said determination may be made by the determination
unit 214 either alone or in conjunction with the processor 206. In particular, the
processor 206 may evaluate entity parameter-wise digitization readiness of the entity
which thereby allows in understanding which entity parameter needs more attention to
with respect to digitization and thereby proceed accordingly.
[060] It may be appreciated that the processor 206, based on the logics provided at various
stages may calculate the scores and once the scores are calculated for various samples
for a predefined time, then one or more machine learning models may be utilized to
provide the scores at various stages based on the historical information available with
the computing device 102.
[061] Figure 3 depicts, by way of a flowchart, a method 300 for assessing quality
management system (QMS) auditing in accordance with an embodiment of the present
disclosure. The order in which the method 300 is described is not intended to be
construed as a limitation, and any number of the described method steps may be
combined in any order to implement the method. Additionally, individual steps may be
deleted from the methods without departing from the spirit and scope of the subject
matter described.
[062] At step 302, the method 300 may include identifying, from a plurality of clauses, one
or more clauses to be audited. In one exemplary embodiment, the processor 206 may
be configured to facilitate identification of clauses for an auditor. In particular, the
processor 206 may determine for a particular quality standard, a plurality of applicable
clauses and may present the same to the auditor to allow an auditor to choose one or
more clauses that are most for auditing. In one exemplary embodiment, each clause
may comprise one or more sub-clauses and the auditor may upon choosing a clause
may be presented with the most relevant sub-clauses.
19
[063] At step 304, the method 300 may include calculating a score at each stage of a plurality
of stages of auditing for a clause of the identified one or more clauses. In one exemplary
embodiment, for calculation of score at each stage of auditing, the processor 206 may
be employed. Further, at each stage of auditing, score may be calculated based on at
least one of:
a level of understanding of scope of the clause,
a level of implementation of the clause,
a level of establishment of standard operating procedure (SOP) for the clause,
a level of identification of at least one of: quality parameters and entity
parameters for the clause, and
a level of digitization of each of the entity parameters for the clause.
[064] Based on the calculated scores at each stage of auditing, the method 300 may proceed
to step 306.
[065] At step 306a, the method 300 may include determining whether the entity is compliant
with the one or more quality standards. In one exemplary embodiment, for making said
determination, the processor 206 may be employed.
[066] At step 306b, the method 300 may include calculating a comprehensive score (S4) for
the one or more quality standards indicating a level of digitization of the QMS. In one
exemplary embodiment, for calculating the comprehensive score (S4), the processor
206 may be employed. Detailed explanation about how to calculate the comprehensive
score is provided in above paragraphs and same is omitted here for the sake of brevity.
[067] The illustrated steps are set out to explain the exemplary embodiments shown, and it
should be anticipated that ongoing technological development will change the manner
in which particular functions are performed. These examples are presented herein for
purposes of illustration, and not limitation. Further, the boundaries of the functional
building blocks have been arbitrarily defined herein for the convenience of the
description. Alternative boundaries can be defined so long as the specified functions
and relationships thereof are appropriately performed.
[068] Furthermore, one or more computer-readable storage media may be utilized in
implementing embodiments consistent with the present disclosure. A computer-
20
readable storage medium refers to any type of physical memory on which information
or data readable by a processor may be stored. Thus, a computer-readable storage
medium may store instructions for execution by one or more processors, including
instructions for causing the processor(s) to perform steps or stages consistent with the
embodiments described herein. The term “computer- readable medium” should be
understood to include tangible items and exclude carrier waves and transient signals,
i.e., are non-transitory. Examples include random access memory (RAM), read-only
memory (ROM), volatile memory, non-volatile memory, hard drives, CD ROMs,
DVDs, flash drives, disks, and any other known physical storage media.
[069] Suitable processors include, by way of example, a general-purpose processor, a special
purpose processor, a conventional processor, a digital signal processor (DSP), a graphic
processing unit (GPU), a plurality of microprocessors, one or more microprocessors in
association with a DSP core, a controller, a microcontroller, Application Specific
Integrated Circuits (ASICs), Field Programmable Gate Arrays (FPGAs) circuits, any
other type of integrated circuit (IC), and/or a state machine.
21
We Claim:
1. An assessment method for quality management system (QMS) auditing, wherein the QMS
comprises a plurality of clauses corresponding to one or more quality standards to be
complied by an entity, the method comprising:
identifying (302), from the plurality of clauses, one or more clauses to be audited,
wherein the one or more clauses are associated with a quality standard of the one or more
quality standards;
for a clause of the identified one or more clauses, calculating (304) a score at each
stage of a plurality of stages of auditing, wherein the score at each stage of auditing is
calculated based on at least one of:
a level of understanding of scope of the clause
a level of implementation of the clause,
a level of establishment of standard operating procedure (SOP) for the clause,
a level of identification of at least one of: quality parameters and entity
parameters for the clause, and
a level of digitization of each of the entity parameters for the clause;
based on the calculated score at each stage of auditing for each of the one or more
clauses, performing (306) at least one of:
determining (306a) whether the entity is compliant with the one or more quality
standards; and
calculating (306b) a comprehensive score (S4) for the one or more quality
standards indicating a level of digitization of the QMS.
2. The method as claimed in claim 1, wherein each clause comprises one or more sub-clauses.
3. The method as claimed in claim 1, wherein calculating a score at each stage of a plurality of
stages of auditing further comprises:
calculating a score (S) at first stage of the plurality of stages of auditing based on a
level of understanding of the clause (U) and a level of implementation (T) of the clause;
22
calculating a score (I) at second stage of the plurality of stages of the auditing based
on a level of establishment of standard operating procedure (SOP) (P) for the clause and the
level of identification of at least one of: quality parameters (Qi) and entity parameters (Ei)
for the clause; and
calculating a first cumulative score (So) based on the score calculated at the first stage
and the second stage.
4. The method as claimed in claim 1, further comprises:
calculating an intermediate score (S1k) corresponding to subsequent stages of auditing
based on the level of digitization of the entity parameter, wherein the intermediate score is
calculated based on a level of digitization in at least one of: sensing of the entity parameter,
storing the entity parameter, making decisions associated with the sensed and stored entity
parameter, taking actions on the sensed and stored entity parameter and presenting one or
more evidence documents presented to an auditor.
5. The method as claimed in claim 4, further comprising:
calculating a digitization score (S2k) for the entity based on the level of digitization
achieved for each of the entity parameters (Ei).
6. The method as claimed in claim 5, further comprising:
calculating a second cumulative score (S2) corresponding to the level of digitization
of the one or more sub-clauses of each clause.
7. The method as claimed in claim 1, further comprises:
calculating an overall score (S3) for each clause of the one or more clauses based on
the first cumulative score (So) and the second cumulative score (S2).
8. The method as claimed in claim 1, wherein calculating the comprehensive score (S4) further
comprises:
calculating the comprehensive score (S4) for each quality standard based on the overall
score (S3) of each clause of the one or more clauses associated with each quality standard.
9. A computing device (102) for assessing quality management system (QMS) auditing,
wherein the QMS comprises a plurality of clauses corresponding to one or more quality
standards to be complied by an entity, the computing device comprising:
a memory (204); and
23
a processor (206) operatively and communicatively coupled to the memory (204),
wherein the processor (206) is configured to:
identify, from the plurality of clauses, one or more clauses to be audited, wherein
the one or more clauses are associated with a quality standard of the one or more
quality standards;
for a clause of the identified one or more clauses, calculate a score at each stage
of a plurality of stages of auditing, wherein the score at each stage of auditing is
calculated based on at least one of:
a level of understanding of scope of the clause
a level of implementation of the clause,
a level of establishment of standard operating procedure (SOP) for the
clause,
a level of identification of at least one of: quality parameters and entity
parameters for the clause, and
a level of digitization of each of the entity parameters for the clause;
based on the calculated score at each stage of auditing for each of the one or
more clauses, perform at least one of:
determine whether the entity is compliant with the one or more quality
standards; and
calculate a comprehensive score (S4) for the one or more quality
standards indicating a level of digitization of the QMS.
10. The computing device as claimed in claim 9, wherein each clause comprises one or more
sub-clauses.
11. The computing device as claimed in claim 9, wherein to calculate a score at each stage of
the plurality of stages of auditing, the processor (206) is further configured to:
calculate a score (S) at first stage of the plurality of stages of auditing based on a level
of understanding of the clause (U) and a level of implementation (T) of the clause;
calculate the score (I) at second stage of the plurality of stages of the auditing based
on a level of establishment of standard operating procedure (SOP) (P) for the clause and the
level of identification of at least one of: quality parameters (Qi) and entity parameters (Ei)
for the clause; and
24
calculate a first cumulative score (So) based on the score calculated at the first stage
and the second stage.
12. The computing device as claimed in claim 9, wherein the processor (206) is further
configured to:
calculate an intermediate score (S1k) corresponding to subsequent stages of auditing
based on the level of digitization of the entity parameter, wherein the intermediate score is
calculated based on a level of digitization in at least one of: sensing of the entity parameter,
storing the entity parameter, making decisions associated with the sensed and stored entity
parameter, taking actions on the sensed and stored entity parameter and presenting one or
more evidence documents presented to an auditor.
13. The computing device as claimed in claim 12, wherein the processor (206) is further
configured to:
calculate a digitization score (S2k) for the entity based on the level of digitization
achieved for each of the entity parameters (Ei).
14. The computing device as claimed in claim 13, wherein the processor is further configured
to:
calculate a second cumulative score (S2) corresponding to the level of digitization of
the one or more sub-clauses of each clause.
15. The computing device as claimed in claim 9, wherein the processor (206) is further
configured to:
calculate an overall score (S3) for each clause of the one or more clauses based on the
first cumulative score (So) and the second cumulative score (S2).
16. The computing device as claimed in claim 9, wherein to calculate the comprehensive score,
the processor (206) is further configured to:
calculate the comprehensive score (S4) for each quality standard based on the overall
score (S3) of each clause of the one or more clauses associated with each quality standard.
TECHNICAL FIELD
[001] The present invention generally relates to the field of assessment methodologies and
more particularly relates to assessment of quality management system (QMS) auditing
towards digitization and implementation.
BACKGROUND OF INVENTION
[002] The following description includes information that may be useful in understanding the
present invention. It is not an admission that any of the information provided herein is
prior art or relevant to the presently claimed invention, or that any publication
specifically or implicitly referenced is prior art.
[003] With the start of the fourth industrial revolution or Industry 4.0 (I4.0), the principles of
the I4.0 has been influenced all cross domains of the manufacturing industry. Further,
the quality domain of the manufacturing industry is greatly benefited by the
implementation of I4.0 and has emerged as a new era as Quality 4.0 (Q4.0).
[004] Many digital technologies have been researched to get insights related to the benefits
and challenges associated with use of I4.0 or Q4.0 within the manufacturing industries.
However, there is still room for monitoring the digital technologies’ impact on product
lifecycle regulatory compliance. In the context of digitization efforts in the
manufacturing sector, many countries depict high readiness while certain countries are
depicting a slow-paced digital readiness. The reason being, manufacturers are still not
aware or are lacking maturity in terms of understanding the need of digitization in the
organisation. Self-assessment/ auditing of the organisation shall provide insights on
areas where digital adoption is necessary. In this regard, quality management plays
crucial role. Quality 4.0 being a relatively new concept, poses many challenges for the
industries as they find it difficult to assess whether they are ready for implementation
of Quality 4.0 or not. Many models of assessment are available, but most of the do not
assess Quality 4.0 from the delivery excellence perspective. In delivery excellence, a
dedicated quality department manages quality and that is accomplished through audits,
process monitoring, conformance of the product with standards. The industry’s
digitization roadmap should begin with an assessment of the industry's digital maturity
level which is severely lacking.
3
[005] There is therefore a need for a maturity model capable of assessing the digital readiness
along with functions of quality management in delivery excellence.
OBJECT OF THE INVENTION
[006] An object of the invention is to assess an organization’s maturity towards digitalization
of QMS, during audits resulting in the identification of gaps in both digitization and
QMS implementation.
SUMMARY OF THE INVENTION
[007] The present disclosure overcomes one or more shortcomings of the prior art and
provides additional advantages. Embodiments and aspects of the disclosure described
in detail herein are considered a part of the claimed disclosure.
[008] In one non-limiting embodiment of the present disclosure, an assessment method for
quality management system (QMS) auditing is disclosed. In one aspect, the QMS
comprises a plurality of clauses corresponding to one or more quality standards to be
complied by an entity. The method comprises identifying, from the plurality of clauses,
one or more clauses to be audited. In one aspect, the one or more clauses are associated
with a quality standard of the one or more quality standards. Further, for a clause of the
identified one or more clauses, the method further comprises calculating a score at each
stage of a plurality of stages of auditing. In one aspect, the score at each stage of
auditing is calculated based on at least one of: a level of understanding of scope of the
clause, a level of implementation of the clause, a level of establishment of standard
operating procedure (SOP) for the clause, a level of identification of at least one of:
quality parameters and entity parameters for the clause, and a level of digitization of
each of the entity parameters for the clause. Based on the calculated score at each stage
of auditing for each of the one or more clauses, the method further comprises
performing at least one of: determining whether the entity is compliant with the one or
more quality standards and calculating a comprehensive score for the one or more
quality standards indicating a level of digitization of the QMS.
4
[009] In another non-limiting embodiment of the present disclosure, each clause comprises
one or more sub-clauses.
[010] In yet another non-limiting embodiment of the present disclosure, calculating a score
at each stage of a plurality of stages of auditing further comprises calculating a score
(S) at first stage of the plurality of stages of auditing based on a level of understanding
of the clause and a level of implementation of the clause. The method further comprises
calculating a score (I) at second stage of the plurality of stages of the auditing based on
a level of establishment of standard operating procedure (SOP) for the clause and the
level of identification of at least one of: quality parameters and entity parameters for
the clause and calculating a first cumulative score based on the score calculated at the
first stage and the second stage.
[011] In yet another non-limiting embodiment of the present disclosure, the method further
comprises further comprises calculating an intermediate score corresponding to
subsequent stages of auditing based on the level of digitization of the entity parameter.
In one aspect, the intermediate score is calculated based on a level of digitization in at
least one of: sensing of the entity parameter, storing the entity parameter, making
decisions associated with the sensed and stored entity parameter, taking actions on the
sensed and stored entity parameter and presenting one or more evidence documents
presented to an auditor.
[012] In yet another non-limiting embodiment of the present disclosure, the method further
comprises calculating a digitization score for the entity based on the level of digitization
achieved for each of the entity parameters.
[013] In yet another non-limiting embodiment of the present disclosure, the method further
comprises calculating a second cumulative score corresponding to the level of
digitization of the one or more sub-clauses of each clause.
[014] In yet another non-limiting embodiment of the present disclosure, the method further
comprises calculating an overall score for each clause of the one or more clauses based
on the first cumulative score and the second cumulative score.
[015] In yet another non-limiting embodiment of the present disclosure, calculating the
comprehensive score further comprises calculating the comprehensive score for each
5
quality standard based on the overall score of each clause of the one or more clauses
associated with each quality standard.
[016] In yet another non-limiting embodiment of the present disclosure, a computing device
for assessing quality management system (QMS) auditing is disclosed. In one aspect,
the QMS comprises a plurality of clauses corresponding to one or more quality
standards to be complied by an entity. The computing device comprises a memory and
a processor operatively and communicatively coupled to the memory. In one aspect,
the processor is configured to identify, from the plurality of clauses, one or more clauses
to be audited. In one aspect, the one or more clauses are associated with a quality
standard of the one or more quality standards. For a clause of the identified one or more
clauses, the processor is further configured to calculate a score at each stage of a
plurality of stages of auditing. In one aspect the score at each stage of auditing is
calculated based on at least one of: a level of understanding of scope of the clause, a
level of implementation of the clause, a level of establishment of standard operating
procedure (SOP) for the clause, a level of identification of at least one of: quality
parameters and entity parameters for the clause, and a level of digitization of each of
the entity parameters for the clause. Based on the calculated score at each stage of
auditing for each of the one or more clauses, the processor is further configured to
perform at least one of: determine whether the entity is compliant with the one or more
quality standards and calculate a comprehensive score for the one or more quality
standards indicating a level of digitization of the QMS.
[017] In yet another non-limiting embodiment of the present disclosure, to calculate a score
at each stage of a plurality of stages of auditing, the processor is further configured to
calculate a score (S) at first stage of the plurality of stages of auditing based on a level
of understanding of the clause and a level of implementation of the clause. The
processor is further configured to calculate a score (I) at second stage of the plurality
of stages of the auditing based on a level of establishment of standard operating
procedure (SOP) for the clause and the level of identification of at least one of: quality
parameters and entity parameters for the clause and the processor is further configured
to calculate a first cumulative score based on the score calculated at the first stage and
the second stage.
6
[018] In yet another non-limiting embodiment of the present disclosure, the processor is
further configured to calculate an intermediate score corresponding to subsequent
stages of auditing based on the level of digitization of the entity parameter. In one
aspect, the intermediate score is calculated based on a level of digitization in at least
one of: sensing of the entity parameter, storing the entity parameter, making decisions
associated with the sensed and stored entity parameter, taking actions on the sensed and
stored entity parameter and presenting one or more evidence documents presented to
an auditor.
[019] In yet another non-limiting embodiment of the present disclosure, the processor is
further configured to calculate a digitization score for the entity based on the level of
digitization achieved for each of the entity parameters.
[020] In yet another non-limiting embodiment of the present disclosure, the processor is
further configured to calculate a second cumulative score corresponding to the level of
digitization of the one or more sub-clauses of each clause.
[021] In yet another non-limiting embodiment of the present disclosure, the processor is
further configured to calculate an overall score for each clause of the one or more
clauses based on the first cumulative score and second cumulative score.
[022] In yet another non-limiting embodiment of the present disclosure, to calculate the
comprehensive score, the processor is further configured to calculate the
comprehensive score for each quality standard based on the overall score of each clause
of the one or more clauses associated with each quality standard.
[023] The foregoing summary is illustrative only and is not intended to be in any way limiting.
In addition to the illustrative aspects, embodiments, and features described above,
further aspects, embodiments, and features will become apparent by reference to the
drawings and the following detailed description.
BRIEF DESCRIPTION OF DRAWINGS
[024] The features, nature, and advantages of the present disclosure will become more
apparent from the detailed description set forth below when taken in conjunction with
the drawings in which like reference characters identify correspondingly throughout.
7
Some embodiments of system and/or methods in accordance with embodiments of the
present subject matter are now described, by way of example only, and with reference
to the accompanying Figs., in which:
[025] Figures 1A-1D depict exemplary environments 100A-100D of a computing device for
assessing quality management system (QMS) auditing in accordance with an
embodiment of the present disclosure,
[026] Figure 2 depicts a block diagram 200 of a computing device for assessing quality
management system (QMS) auditing in accordance with an embodiment of the present
disclosure, and
[027] Figure 3 depicts, by way of a flow chart, a method 300 for assessing quality
management system (QMS) auditing in accordance with an embodiment of the present
disclosure.
[028] It should be appreciated by those skilled in the art that any block diagrams herein
represent conceptual views of illustrative systems embodying the principles of the
present subject matter. Similarly, it will be appreciated that any flow charts, flow
diagrams, state transition diagrams, pseudo code, and the like represent various
processes which may be substantially represented in a computer readable medium and
executed by a computer or processor, whether or not such computer or processor is
explicitly shown.
DETAILED DESCRIPTION
[029] The foregoing has broadly outlined the features and technical advantages of the present
disclosure in order that the detailed description of the disclosure that follows may be
better understood. It should be appreciated by those skilled in the art that the conception
and specific embodiment disclosed may be readily utilized as a basis for modifying or
designing other structures for carrying out the same purposes of the present disclosure.
[030] The novel features which are believed to be characteristic of the disclosure, both as to
its organization and method of operation, together with further objects and advantages
will be better understood from the following description when considered in connection
8
with the accompanying figures. It is to be expressly understood, however, that each of
the figures is provided for the purpose of illustration and description only and is not
intended as a definition of the limits of the present disclosure.
[031] The present disclosure is directed towards assessing an entity’s maturity towards
digitization of QMS, during audits and thereby identify gaps in both digitization and
QMS implementation. It may be noted by a skilled person that the entity may be an
industry, or an organization associated with manufacturing sector. Further, the present
disclosure provides freedom to the auditors to perform audits clause-wise and/or as per
a checklist method. A skilled person may select any audit methodology based on their
preference. In particular, the present disclosure employs a scoring-based methodology
to evaluate the quality standard compliance of the entity and the maturing of digitization
of the QMS. A detailed description of the disclosure is provided in the upcoming
paragraphs in conjunction with figures 1A-1D and 2.
[032] Figures 1A-1D depict exemplary environments 100A-100D of a computing device for
assessing quality management system (QMS) auditing in accordance with an
embodiment of the present disclosure. In particular, figure 1A depicts an exemplary
environment of a computing device 102 that performs the assessment in various stages.
The various stages illustrated in Figure 1A are listed as follows –
Stage 0 – Clause identification
Stage 1 – Scope of Clause
Stage 2 – Identify
Stage 3 – Sense parameters
Stage 4 – Network (Store)
Stage 5 – Decide
Stage 6 – Action
Stage 7 – QMS Documents and Records
However, it may be noted by a skilled person that the number of stages and the order
of implementation may vary based on the requirement.
[033] At each stage of auditing, starting from the first stage (Stage 1) till the seventh stage
(Stage 7), a score is calculated based on which it is determined whether the entity is
complying the quality standards or not and the current level of digitization of the QMS.
A detailed description of the implementation of each of the above-mentioned stages (as
9
presented in figures 1A-1D) is explained in forthcoming paragraphs in conjunction with
figure 2.
[034] Figure 2 depicts an exemplary block diagram 200 of a computing device 102 for
assessing quality QMS auditing in accordance with an embodiment of the present
disclosure. The computing device 102 comprises an I/O interface 202, a memory 204,
a processor 206 and units 208. The processor 206 may be operatively coupled to the
I/O interface 202 and the memory 204. In one exemplary embodiment, the units 208
may comprise an identification unit 210, a score calculation unit 212 and a
determination unit 214.
[035] Further, in one implementation, the processor 206 may be implemented as one or more
microprocessors, microcomputers, microcontrollers, digital signal processors, central
processing units, state machines, logic circuitries, and/or any devices that manipulate
signals based on operational instructions. Among other capabilities, the at least one
processor 206 may be configured to fetch and execute computer-readable instructions
stored in the memory 204. The I/O interface 202 may include a variety of software and
hardware interfaces, for example, a web interface, a graphical user interface, and the
like.
[036] The I/O interface 202 may include a variety of software and hardware interfaces, for
example, a web interface, a graphical user interface, and the like. The I/O interface 202
may enable the computing device 102 or specifically the processor 206 to communicate
with other components such as a network entity 216 and any other components (not
shown in figures). The I/O interface 202 may facilitate multiple communications within
a wide variety of networks and protocol types, including wired networks, for example,
LAN, cable, etc., and wireless networks, such as WLAN, cellular, or satellite.
[037] According to embodiments of present disclosure, the units 208 may comprise dedicated
hardware components like processor, microprocessor, microcontrollers, applicationspecific integrated circuit (ASIC) which interacts with each other for performing
various operations of the computing device 102. It must be understood to a person
skilled in art that the processor 206 may also perform all the functions of the units 208
according to various embodiments of the present disclosure.
10
[038] Referring back to figure 1A, at stage 0, the processor 206 may be configured to facilitate
identification of clauses for an auditor. In particular, the processor 206 may determine
for a particular quality standard, a plurality of applicable clauses and may present the
same to the auditor to allow an auditor to choose one or more clauses that are most
relevant for auditing. In one exemplary embodiment, each clause may comprise one or
more sub-clauses and the auditor, upon selection of a clause, may be presented with the
sub-clauses. In an embodiment, the auditor may be provided with set of most relevant
sub-clauses instead of all sub clauses. For instance, for a particular quality standard, the
clauses may comprise management responsibility, resource management, product
realization, general etc., and each clause may include one or more sub-clauses. For
instance, the clause “general” may include sub-clauses like roles undertaken, procedure
for documentation requirements etc. Further, for each identified clause, relevant
documents may be accessed through the network entity 212. In one exemplary
embodiment, the identification of clauses may be performed by the identification unit
210 either alone or in conjunction with the processor 206.
[039] Upon identification of the clauses, the assessment may move onto the next stage i.e.,
the first stage (Stage 1) as illustrated in figure 1A. At stage 1 of the assessment, the
scope of the clause is assessed. In particular, for assessing the scope of the clause, the
auditor may judge a level of understanding (U) and a level of implementation (I) for
each sub-clause of the one or more clauses. In one exemplary embodiment, the auditor
may judge the level of understanding (U) of each-sub clause of a clause based on
whether the sub-clause is fully understood, partially understood or not understood.
Further, in one exemplary embodiment, the auditor may judge the level of
implementation (I) of each sub-clause based on whether the sub-clause is fully
implemented, partially implemented or not implemented. Once, said exercise is
completed for each sub-clause, the processor 206 calculates a score (S) according to
equation (1) –
࢏ࢀ + ࢏ࢁ) = ܁
(1 (ࢄ/(
[040] wherein, i = 1, 2, 3,… N, denotes a number of sub-clauses for the clause and 1/X
indicates a weight associated with calculation of the score (S). It may be noted by a
skilled person that said weight may be chosen based on the clause being evaluated or
the quality standard in question. Further, in one exemplary embodiment, score
11
calculation may be performed by the score calculation unit 212 either alone or in
conjunction with the processor 206.
[041] In one exemplary embodiment, if the scope of a given sub-clause is fully understood,
the processor 206 may provide or calculate a 100% score and if the scope of the subclause is not understood, the processor 206 may calculate or provide a score of 0.
Similarly, if each sub-clause is fully implemented, the processor 206 may calculate or
provide a 100% score and if each sub-clause if not implemented at all, the processor
206 may calculate or provide a score 0. Further, if the scope of the sub-clause is partially
understood and if the sub-clause is partially implemented, the processor 206 may
calculate a score ranging between 0 to 100% based on a scoring scheme determined by
either the auditor or the computing device 102 based on an extent to which the scope
of the sub-clause is understood and an extent to which the sub-clause is implemented.
However, it may be noted by a skilled person that the scoring may be provided by the
processor 206 in an alternative manner including but not limited to an absolute value, a
grade etc.
[042] Moving on, at the second stage (Stage 2) of auditing as illustrated in figure 1B. At stage
2 of the assessment, it is assessed whether the necessary Standard Operating Procedures
(SOP), quality parameters and entity parameters are identified and established. In
accordance with an embodiment of the present disclosure, the SOP may be developed
based on the quality parameters (Qi) and entity parameters (Ei) for the process and
product. In one exemplary embodiment, the quality parameters (Qi) may comprise the
parameters which are measured as part of the quality management strategies and may
be subject to identification by the entity based on their quality objectives. Further, the
entity parameters (Ei) may include parameters such as Materials/Objects, Machine,
Human, Information, Energy and Environment and the quality parameters (Qi) may be
identified into separate entity parameters (Ei). The quality parameters (Qi) once
categorized may lead to the identification of new quality parameters (Qi) thus resulting
in modification in SOPs. For instance, for the entity parameter – Materials/Objects, new
quality parameters (Qi) may be identified, including but not limited to quality of
product, dimensions, shape etc. Hence, the quality parameters (Qi) and entity
parameters (Ei) are interdependent with SOP.
12
[043] Referring back to figure 1B, to assess whether the necessary Standard Operating
Procedures (SOP), quality parameters (Qi) and entity parameters (Ei) are identified and
established, the auditor may judge a level of establishment of SOP (P), a level of
identification of quality parameters (Qi) and a level of identification of entity
parameters (Ei). For instance, the auditor may judge the level of establishment of SOP
(P) of each-sub clause based on whether the sub-clause is fully established, partially
established or not established. In one exemplary embodiment, if the SOP is fully
established, the processor 206 may provide a 100% score and if the SOP is not
established, the processor 206 may provide a score of 0. Further, if the SOP is partially
established, the processor 206 may provide a score ranging between 0 to 100% based
on a scoring scheme determined by either the auditor or the computing device 102 based
on an extent to which the SOP is established. Further, the auditor may judge the level
of identification of quality parameters (Qi) and the level of identification of entity
parameters (Ei) of each sub-clause based on whether the quality parameters (Qi) and the
entity parameters (Ei) are identified or not identified. In one exemplary embodiment,
the processor 206 may consider a score of 100% if the quality parameters Qi) and the
entity parameters (Ei) are identified and may provide a score of zero if the quality
parameters (Qi) and the entity parameters (Ei) are not identified. However, it may be
noted by a skilled person that the scoring may be provided by the processor 206 in an
alternative manner including but not limited to an absolute value, a grade etc. Further,
the auditor may also select the entity parameters out of Materials/Objects, Machine,
Human, Information, Energy and Environment that are relevant for the particular subclause being assessed. Once, said exercise is completed for each sub-clause, the
processor 206 calculates a score (I) according to equation (2)–
࢏ࡱ + ࢏ࡽ + ࢏ࡼ) = ࡵ
(2 (ࢅ/(
[044] where, i = 1, 2, 3,… N, denotes a number of sub-clauses for the clause and 1/Y denotes
a weight associated with calculation of the score (I). However, it may be noted by a
skilled person that said weight may be chosen based on the clause being evaluated or
the quality standard in question. In an exemplary embodiment, the weights may be
equal to one another In another embodiment, the weights 1/X and 1/Y are not equal to
one another. Further, in one exemplary embodiment, score calculation may be
performed by the score calculation unit 212 either alone or in conjunction with the
processor 206.
13
[045] Upon calculation of score (S) at the first stage (Stage 1) and the calculation of the score
(I) at the second stage (Stage 2), the processor 206 may calculate a first cumulative
score (So) according to equation (3) –
S0 = (S+I)/Z (3)
where, 1/Z denotes the weight associated with the first two stages (Stage 1, Stage 2) of
assessment with respect to the remaining stages (Stages 3-7) of assessment. However,
it may be noted by a skilled person that said weight may be chosen based on the clause
being evaluated or the quality standard in question or the further stages to be
implemented. Further, in one exemplary embodiment, score calculation may be
performed by the score calculation unit 212 either alone or in conjunction with the
processor 206.
[046] It may be noted by a skilled person that stages 0-2 of the assessment are input stages
where the auditor refers to standard documents as obtained from the network entity 212.
The upcoming stages 3-6 are output stages with data being output for requirements of
the quality standard. Further, the final stage, i.e., Stage 7 is used to evaluate the
generated evidence.
[047] Now, figure 1C depicts the implementation of Stages 3-7 of the assessment. At the third
stage (Stage 3) of the assessment, a level of digitization utilized in sensing each entity
parameter (Ei) is assessed. In one exemplary embodiment, the auditor may assess the
level of digitization utilized in sensing entity parameter (Ei) based on whether the
sensing of the entity parameter (Ei) is implemented or not. Further, if the sensing of the
entity parameter (Ei) is implemented, it may then be assessed whether the entity
parameter (Ei) is sensed manually, partially manually, partially automatically or
automatically. Once, the exercise is completed, the processor 206 may calculate a score
(R). In one exemplary embodiment, if the sensing of the entity parameter (Ei) is not
implemented, the processor 206 may calculate or consider the score (R) as zero. On
similar lines, if the sensing of the entity parameter (Ei) is implemented manually,
partially manually and partially digitally, the processor 206 may calculate the score (R)
as 25%, 50% and 75% respectively. Further, if the sensing of the entity parameter (Ei)
is implemented digitally, the processor 206 may calculate or consider the score (R) as
100%. However, it may be noted by a skilled person that the scoring may be provided
by the processor 206 in an alternative manner including but not limited to an absolute
14
value, a grade etc. A person skilled in the art may appreciate that the above- mentioned
scores are not fixed but may vary depending on the requirement imposed by the auditor
or operator of the computing device. Further, in one exemplary embodiment, score
calculation may be performed by the score calculation unit 212 either alone or in
conjunction with the processor 206.
[048] At the fourth stage (Stage 4) of the assessment, a level of digitization utilized in
networking or storing the sensed entity parameters (Ei) is assessed. In one exemplary
embodiment, the auditor may assess the level of digitization utilized in storing each
sensed entity parameter (Ei) based on whether the sensed entity parameter (Ei) is stored
or not. If the entity parameter is stored, it may be assessed whether the sensed entity
parameter (Ei) is stored in a paper (Physical) form or entered into a digital form (Partial
physical) or both, or the entity parameter (Ei) is triggered physically and stored digitally
(Partial digital) or stored without human intervention (Digital). Once, the exercise is
completed, the processor 206 may calculate a score (N). In one exemplary embodiment,
if the storing of the sensed entity parameter (Ei) is not implemented, the processor 206
may calculate or consider the score (N) as zero. On similar lines, if the sensed entity
parameter (Ei) is stored partially physically or partially digitally, the processor 206 may
calculate and provide a score (N) ranging between 0 to 100% based on a scoring scheme
determined by either the auditor or the computing device 102 based on an extent to
which the sensed entity parameter (Ei) is stored physically and digitally. Further, if the
sensed entity parameter (Ei) is stored both physically and digitally or fully digitally, the
processor 206 may calculate or consider the score (N) as 100%. However, it may be
noted by a skilled person that the scoring may be provided by the processor 206 in an
alternative manner including but not limited to an absolute value, a grade etc. Further,
in one exemplary embodiment, score calculation may be performed by the score
calculation unit 212 either alone or in conjunction with the processor 206.
[049] At the fifth stage (Stage 5) of the assessment, a level of digitization utilized in making
decisions associated with the sensed entity parameters (Ei) is assessed. In one
exemplary embodiment, the auditor may assess the level of digitization utilized in
making decisions associated with the sensed entity parameters (Ei) based on whether
the decision-making is implemented or not. Further, it is also assessed whether the
decisions pertaining to the sensed entity parameters (Ei) are made based on physical
15
data, digital data, partially physical data, partially digital data or both physical and
digital data. Once, the exercise is completed, the processor 206 may calculate a score
(D). In one exemplary embodiment, if the decision-making is not implemented, the
processor 206 may consider the score (D) as 0. On similar lines, if the decision-making
is implemented based either digital data or both physical and digital data, the processor
206 may consider the score (D) as 100%. On similar lines, if the decision-making is
based on partially physical data or partial digital data, the processor 206 may calculate
and provide a score (D) ranging between 0 to 100% based on a scoring scheme
determined by either the auditor or the computing device 102 based on an extent to
which the decision-making is based on partially physical data and partial digital data.
However, it may be noted by a skilled person that the scoring may be provided by the
processor 206 in an alternative manner including but not limited to an absolute value, a
grade etc. Further, in one exemplary embodiment, score calculation may be performed
by the score calculation unit 212 either alone or in conjunction with the processor 206.
[050] At the sixth stage (Stage 6) of the assessment, a level of digitization utilized in
documentation of any action that needs to be taken on the sensed entity parameters (Ei)
is assessed. In one exemplary embodiment, the auditor may assess the level of
digitization utilized in documenting the actions that need to be taken on the sensed
entity parameters (Ei) based on whether the actions to be taken are documented or not.
Further, it is also assessed whether the actions to be taken are documented physically,
partially physically, partially digitally or fully digitally or both physically and digitally.
Once, the exercise is completed, the processor 206 may calculate a score (A). In one
exemplary embodiment, if the actions to be taken are not documented, the processor
206 may consider the score (A) as 0. On similar lines, if the actions to be taken are
documented both physically and digitally or only digitally, the processor 206 may
consider the score (A) as 100%. On similar lines, if the actions to be taken are
documented either partially physically or partially digitally, the processor 206 may
calculate and provide a score (A) ranging between 0 to 100% based on a scoring scheme
determined by either the auditor or the computing device 102 based on an extent to
which the actions to be taken are documented physically and digitally. However, it
may be noted by a skilled person that the scoring may be provided by the processor 206
in an alternative manner including but not limited to an absolute value, a grade etc.
16
Further, in one exemplary embodiment, score calculation may be performed by the
score calculation unit 212 either alone or in conjunction with the processor 206.
[051] At the seventh stage (Stage 7) of the assessment, a level of digitization of the available
documents/records (evidence), essential for auditing, is assessed. In one exemplary
embodiment, the auditor may assess a level of digitization in a manner in which the
documents/records are available to an auditor based on whether the actions to be taken
are documented or not. Further, it is also assessed whether documents/records are
available or not. If the documents/records are available, whether the same are available
in a physical form, partially physical form, partially digital form or fully digital form.
Once, the exercise is completed, the processor 206 may calculate a score (C). In one
exemplary embodiment, if the documents/records are not available to an auditor, the
processor 206 may consider or calculate the score (C) as 0. On similar lines, if the
documents/records are available in both physical and digital form or only digital form,
the processor 206 may consider or calculate the score (C) as 100%. On similar lines, if
the documents/records are available in either partially physical or partially digital form,
the processor 206 may calculate and provide a score (C) ranging between 0 to 100%
based on a scoring scheme determined by either the auditor or the computing device
102 based on an extent to which the documents/records are available in physical form
and digital form. However, it may be noted by a skilled person that the scoring may be
provided by the processor 206 in an alternative manner including but not limited to an
absolute value, a grade etc. Further, in one exemplary embodiment, score calculation
may be performed by the score calculation unit 212 either alone or in conjunction with
the processor 206.
[052] Upon calculation of the scores R, N, D, A and C in stages 3-7 for a given entity
parameter, the processor 206 may calculate an intermediate score (S1k) for the given
entity parameter based on the scores obtained in stages 3-7 according to equation (4) –
(4 (5) /࡯ + ࡭ + ࡰ + ࡺ + ࡾ) = ࢑૚ࡿ
[053] In one exemplary embodiment, the intermediate score (S1k) may be an average score
for the given entity parameter and hence, the dividing factor 1/5 as depicted in equation
(4) may vary depending upon the number of stages. Further, the processor 206 may
calculate the intermediate score (S1k) for each entity parameter that has been selected
17
by the auditor and upon completion of the exercise, may calculate a digitization score
(S2k) for the entity based on the intermediate scores calculated for each of the entity
parameters according to equation (5) –
(5) (࡮) ∗ (࢔/࢑૚ࡿ ∑) = S2k
[054] where, n denotes a number of entity parameters and B denotes a weight associated with
calculation of the digitization score (S2k). However, it may be noted by a skilled person
that said weight may be chosen based on the clause being evaluated or the quality
standard in question. Further, in one exemplary embodiment, score calculation may be
performed by the score calculation unit 212 either alone or in conjunction with the
processor 206.
[055] Moving on, upon calculation of the digitization score (S2k) for all the entity parameters
(Ei) associated with a given sub-clause, the processor 206 may calculate a second
cumulative score (S2) based on the digitization scores (S2k) of all the sub-clauses within
a given clause according to equation (6) –
(6 (100 *࢔/(࢑૛ࡿ)∑ =S2
where, n denotes the number of sub-clauses. Further, in one exemplary embodiment,
score calculation may be performed by the score calculation unit 212 either alone or in
conjunction with the processor 206.
[056] Next, the processor 206 may then calculate an overall score (S3) for each clause of the
one or more clauses based on the first cumulative score (So) and second cumulative
score (S2) according to equation (7) –
S3= (S2 + S0) (7)
[057] Further, in one exemplary embodiment, score calculation may be performed by the
score calculation unit 212 either alone or in conjunction with the processor 206.
[058] At last, the processor 206 may calculate a comprehensive score (S4) for the particular
quality standard based on the overall score (S3) of all the clauses pertaining to the
quality standard such that the comprehensive score (S4) indicates a level of digitization
of the QMS. The comprehensive score (S4) may be calculated by the processor 206
according to equation (8) –
૜ࡿ)∑) = S4
(8) ∗ ૚૙૙ (࢔/(
18
where, n indicate the number of clauses. Further, in one exemplary embodiment, score
calculation may be performed by the score calculation unit 212 either alone or in
conjunction with the processor 206.
[059] Based on the calculated scores at each stage and the comprehensive score (S4), the
processor 206 may determine whether the entity is compliant with a particular quality
standard or not and may also be able to determine a digitization readiness of the QMS.
In one exemplary embodiment, said determination may be made by the determination
unit 214 either alone or in conjunction with the processor 206. In particular, the
processor 206 may evaluate entity parameter-wise digitization readiness of the entity
which thereby allows in understanding which entity parameter needs more attention to
with respect to digitization and thereby proceed accordingly.
[060] It may be appreciated that the processor 206, based on the logics provided at various
stages may calculate the scores and once the scores are calculated for various samples
for a predefined time, then one or more machine learning models may be utilized to
provide the scores at various stages based on the historical information available with
the computing device 102.
[061] Figure 3 depicts, by way of a flowchart, a method 300 for assessing quality
management system (QMS) auditing in accordance with an embodiment of the present
disclosure. The order in which the method 300 is described is not intended to be
construed as a limitation, and any number of the described method steps may be
combined in any order to implement the method. Additionally, individual steps may be
deleted from the methods without departing from the spirit and scope of the subject
matter described.
[062] At step 302, the method 300 may include identifying, from a plurality of clauses, one
or more clauses to be audited. In one exemplary embodiment, the processor 206 may
be configured to facilitate identification of clauses for an auditor. In particular, the
processor 206 may determine for a particular quality standard, a plurality of applicable
clauses and may present the same to the auditor to allow an auditor to choose one or
more clauses that are most for auditing. In one exemplary embodiment, each clause
may comprise one or more sub-clauses and the auditor may upon choosing a clause
may be presented with the most relevant sub-clauses.
19
[063] At step 304, the method 300 may include calculating a score at each stage of a plurality
of stages of auditing for a clause of the identified one or more clauses. In one exemplary
embodiment, for calculation of score at each stage of auditing, the processor 206 may
be employed. Further, at each stage of auditing, score may be calculated based on at
least one of:
a level of understanding of scope of the clause,
a level of implementation of the clause,
a level of establishment of standard operating procedure (SOP) for the clause,
a level of identification of at least one of: quality parameters and entity
parameters for the clause, and
a level of digitization of each of the entity parameters for the clause.
[064] Based on the calculated scores at each stage of auditing, the method 300 may proceed
to step 306.
[065] At step 306a, the method 300 may include determining whether the entity is compliant
with the one or more quality standards. In one exemplary embodiment, for making said
determination, the processor 206 may be employed.
[066] At step 306b, the method 300 may include calculating a comprehensive score (S4) for
the one or more quality standards indicating a level of digitization of the QMS. In one
exemplary embodiment, for calculating the comprehensive score (S4), the processor
206 may be employed. Detailed explanation about how to calculate the comprehensive
score is provided in above paragraphs and same is omitted here for the sake of brevity.
[067] The illustrated steps are set out to explain the exemplary embodiments shown, and it
should be anticipated that ongoing technological development will change the manner
in which particular functions are performed. These examples are presented herein for
purposes of illustration, and not limitation. Further, the boundaries of the functional
building blocks have been arbitrarily defined herein for the convenience of the
description. Alternative boundaries can be defined so long as the specified functions
and relationships thereof are appropriately performed.
[068] Furthermore, one or more computer-readable storage media may be utilized in
implementing embodiments consistent with the present disclosure. A computer-
20
readable storage medium refers to any type of physical memory on which information
or data readable by a processor may be stored. Thus, a computer-readable storage
medium may store instructions for execution by one or more processors, including
instructions for causing the processor(s) to perform steps or stages consistent with the
embodiments described herein. The term “computer- readable medium” should be
understood to include tangible items and exclude carrier waves and transient signals,
i.e., are non-transitory. Examples include random access memory (RAM), read-only
memory (ROM), volatile memory, non-volatile memory, hard drives, CD ROMs,
DVDs, flash drives, disks, and any other known physical storage media.
[069] Suitable processors include, by way of example, a general-purpose processor, a special
purpose processor, a conventional processor, a digital signal processor (DSP), a graphic
processing unit (GPU), a plurality of microprocessors, one or more microprocessors in
association with a DSP core, a controller, a microcontroller, Application Specific
Integrated Circuits (ASICs), Field Programmable Gate Arrays (FPGAs) circuits, any
other type of integrated circuit (IC), and/or a state machine.
21
We Claim:
1. An assessment method for quality management system (QMS) auditing, wherein the QMS
comprises a plurality of clauses corresponding to one or more quality standards to be
complied by an entity, the method comprising:
identifying (302), from the plurality of clauses, one or more clauses to be audited,
wherein the one or more clauses are associated with a quality standard of the one or more
quality standards;
for a clause of the identified one or more clauses, calculating (304) a score at each
stage of a plurality of stages of auditing, wherein the score at each stage of auditing is
calculated based on at least one of:
a level of understanding of scope of the clause
a level of implementation of the clause,
a level of establishment of standard operating procedure (SOP) for the clause,
a level of identification of at least one of: quality parameters and entity
parameters for the clause, and
a level of digitization of each of the entity parameters for the clause;
based on the calculated score at each stage of auditing for each of the one or more
clauses, performing (306) at least one of:
determining (306a) whether the entity is compliant with the one or more quality
standards; and
calculating (306b) a comprehensive score (S4) for the one or more quality
standards indicating a level of digitization of the QMS.
2. The method as claimed in claim 1, wherein each clause comprises one or more sub-clauses.
3. The method as claimed in claim 1, wherein calculating a score at each stage of a plurality of
stages of auditing further comprises:
calculating a score (S) at first stage of the plurality of stages of auditing based on a
level of understanding of the clause (U) and a level of implementation (T) of the clause;
22
calculating a score (I) at second stage of the plurality of stages of the auditing based
on a level of establishment of standard operating procedure (SOP) (P) for the clause and the
level of identification of at least one of: quality parameters (Qi) and entity parameters (Ei)
for the clause; and
calculating a first cumulative score (So) based on the score calculated at the first stage
and the second stage.
4. The method as claimed in claim 1, further comprises:
calculating an intermediate score (S1k) corresponding to subsequent stages of auditing
based on the level of digitization of the entity parameter, wherein the intermediate score is
calculated based on a level of digitization in at least one of: sensing of the entity parameter,
storing the entity parameter, making decisions associated with the sensed and stored entity
parameter, taking actions on the sensed and stored entity parameter and presenting one or
more evidence documents presented to an auditor.
5. The method as claimed in claim 4, further comprising:
calculating a digitization score (S2k) for the entity based on the level of digitization
achieved for each of the entity parameters (Ei).
6. The method as claimed in claim 5, further comprising:
calculating a second cumulative score (S2) corresponding to the level of digitization
of the one or more sub-clauses of each clause.
7. The method as claimed in claim 1, further comprises:
calculating an overall score (S3) for each clause of the one or more clauses based on
the first cumulative score (So) and the second cumulative score (S2).
8. The method as claimed in claim 1, wherein calculating the comprehensive score (S4) further
comprises:
calculating the comprehensive score (S4) for each quality standard based on the overall
score (S3) of each clause of the one or more clauses associated with each quality standard.
9. A computing device (102) for assessing quality management system (QMS) auditing,
wherein the QMS comprises a plurality of clauses corresponding to one or more quality
standards to be complied by an entity, the computing device comprising:
a memory (204); and
23
a processor (206) operatively and communicatively coupled to the memory (204),
wherein the processor (206) is configured to:
identify, from the plurality of clauses, one or more clauses to be audited, wherein
the one or more clauses are associated with a quality standard of the one or more
quality standards;
for a clause of the identified one or more clauses, calculate a score at each stage
of a plurality of stages of auditing, wherein the score at each stage of auditing is
calculated based on at least one of:
a level of understanding of scope of the clause
a level of implementation of the clause,
a level of establishment of standard operating procedure (SOP) for the
clause,
a level of identification of at least one of: quality parameters and entity
parameters for the clause, and
a level of digitization of each of the entity parameters for the clause;
based on the calculated score at each stage of auditing for each of the one or
more clauses, perform at least one of:
determine whether the entity is compliant with the one or more quality
standards; and
calculate a comprehensive score (S4) for the one or more quality
standards indicating a level of digitization of the QMS.
10. The computing device as claimed in claim 9, wherein each clause comprises one or more
sub-clauses.
11. The computing device as claimed in claim 9, wherein to calculate a score at each stage of
the plurality of stages of auditing, the processor (206) is further configured to:
calculate a score (S) at first stage of the plurality of stages of auditing based on a level
of understanding of the clause (U) and a level of implementation (T) of the clause;
calculate the score (I) at second stage of the plurality of stages of the auditing based
on a level of establishment of standard operating procedure (SOP) (P) for the clause and the
level of identification of at least one of: quality parameters (Qi) and entity parameters (Ei)
for the clause; and
24
calculate a first cumulative score (So) based on the score calculated at the first stage
and the second stage.
12. The computing device as claimed in claim 9, wherein the processor (206) is further
configured to:
calculate an intermediate score (S1k) corresponding to subsequent stages of auditing
based on the level of digitization of the entity parameter, wherein the intermediate score is
calculated based on a level of digitization in at least one of: sensing of the entity parameter,
storing the entity parameter, making decisions associated with the sensed and stored entity
parameter, taking actions on the sensed and stored entity parameter and presenting one or
more evidence documents presented to an auditor.
13. The computing device as claimed in claim 12, wherein the processor (206) is further
configured to:
calculate a digitization score (S2k) for the entity based on the level of digitization
achieved for each of the entity parameters (Ei).
14. The computing device as claimed in claim 13, wherein the processor is further configured
to:
calculate a second cumulative score (S2) corresponding to the level of digitization of
the one or more sub-clauses of each clause.
15. The computing device as claimed in claim 9, wherein the processor (206) is further
configured to:
calculate an overall score (S3) for each clause of the one or more clauses based on the
first cumulative score (So) and the second cumulative score (S2).
16. The computing device as claimed in claim 9, wherein to calculate the comprehensive score,
the processor (206) is further configured to:
calculate the comprehensive score (S4) for each quality standard based on the overall
score (S3) of each clause of the one or more clauses associated with each quality standard.