Claims:We Claim:

1. A quality tool (PREDICTTM) used for predicting audit or inspection outcome at pharmaceutical manufacturing sites, wherein measurement is based on intangible data and the outcome is useful to interpret the probable outcome of regulatory inspections at a site.

2. A method of evaluation (PREDICTTM) of the site score of a pharmaceutical manufacturing site, wherein the predicted outcome comprises of three elements:

(i) first element or audit score (System score) being assessment of GMP system compliance via check points based on 132 vital parameters;
(ii) second element being SME readiness, which integrates aspects of SME readiness at sites; and
(iii) third element being data integrity compliance scores.

3. The method as claimed in claim 2, wherein the 132 parameters of the first element are categorized into three levels namely Patient Risk (Level-I), Product Quality Risk (Level-II) and Compliance Risk (Level-III).

4. The method as claimed in claim 2, wherein the first element is assessed according to the steps comprising of:
(i) associating each of the 132 parameters with a weightage (%) based on its relevance to patient (highest weightage), product and compliance;
(ii) providing a rating to each of the parameters;
(iii) obtaining the audit score for each of the parameters as a product of weightage and the rating; and
(iv) obtaining the final audit score on a scale of 1 to 24 as an average of the individual scores wherein:
a) Scores ranging from above 22-24 indicates that the site is highly compliant.
b) Scores ranging from above 18-22 indicates that the site is compliant with scope of improvement;
c) Scores ranging from 14-18 indicates that the site is partially compliant with gaps; and
d) Scores less than 14 indicate that the site is non complaint.

5. The method as claimed in claim 4, wherein in step (ii), each of the 132 parameters are assigned with ratings on a scale of 0 to 4 based on level of compliance, wherein:
a) 0 signifies “No process available”,
b) 1 signifies “Non-compliant process”,
c) 2 signifies “Partially compliant process”,
d) 3 signifies “Compliant with improvements” and,
e) 4 signifies “Highly compliant process”.

6. The method as claimed in claim 2, wherein the second element or the SME readiness is provided a score selected from:
a) “0” Need major change in SME at all levels including quality
b) “1” Few critical SMEs (audit facing) in quality requires replacement.
c) “2” Few critical SME ( audit facing) within other 5 systems requires replacement
d) “3” Challenge only with 1 or 2 SME (audit facing) which can be bridged by other competent staff under or at Peer level.
e) “4” Gap in Quality SME (audit facing) but can be trained.
f) “5” Gap in few other SMEs (audit facing) but can be trained.
g) “6” SME (mainly Quality) require extensive level of audit facing training while possessing requisite knowledge.
h) “7” SME (mainly but not only quality) require major level of strategic audit facing training.
i) “8” SME (mainly but not only quality) require low level of audit facing training.
j) “9” SME (mainly quality) requires only incidence related direction or guidance during audit to defend our case as required by regulation during inspection when required.
k) “10” SME (mainly quality) is self-sufficient in changing the course of inspection in our favour due to strong regulatory knowledge and negotiation capability.

7. The method as claimed in claim 2, wherein the third element or data integrity compliance is provided a score in percentage (%) based on the compliance level at the site.

Dated this 28th day of November 2019

SRIDEVI KRISHNAN
GENERAL MANAGER – CORPORATE PATENTS
PIRAMAL ENTERPRISES LIMITED
(APPLICANT)
To,
The Controller of Patents
The Patent Office, At Mumbai
, Description:FORM 2

THE PATENTS ACT, 1970
(39 of 1970)
&
The Patents Rules, 2003

COMPLETE SPECIFICATION
(See section 10 and rule 13)

MONITORING AUDIT READINESS OF PHARMACEUTICAL MANUFACTURING SITES

PIRAMAL ENTERPRISES LIMITED, a company incorporated under the Companies Act 1956, of Piramal Ananta, Agastya Corporate Park, Opposite Fire Brigade, Kamani Junction, LBS Marg, Kurla West, Mumbai - 400070, India

The following specification particularly describes the invention and the manner in which it is to be performed.

Field of the Invention
The present invention relates to a method of evaluating the audit readiness of a pharmaceutical manufacturing site. The method provides for converting an intangible measurement of quality culture in an organization to a tangible value via quantification and hence predicting of audit /inspection.

Background of the Invention
Pharmaceutical products due to their nature of use need a high level of quality assurance. This is because they are used either as a prophylactic or curative drugs. While being used as a prophylactic they are expected to not lead to any complication or health hazard, whether short term or a long term. While being used as a curative, since they are used on patients who already have an underlying medical condition, the product is expected to cure the condition and while doing so should not cause any adverse reaction.

Unlike other high risk industries like automotive, aerospace which also play with human and animal lives; pharmaceutical industries take a more conservative approach. The reason behind this conservative approach is a high risk due to delayed detection of hazards to the biological race. To explain this, in case of a technical issue with an automobile or an aircraft, while it risks the lives to the extent of hazard when it crashes etc., the risk is immediate and future hazards can be prevented by a recall. In case of pharmaceutical industry, the knowledge of hazard caused by a drug to the human race could surface out after a few years or a decade and by which time there would be no way to reverse the onset of such damage that will definitely occur in those patients who have already consumed that drug. This is the reason pharmaceutical inventions undergo multiple clinical studies before they are commercialized and require a strict adherence to regulatory guidance on a continued basis.

Unfortunately, pharmaceutical regulatory guidance is still under the phase of harmonization and it varies from country to country. For e.g. CFRs in US, EU annexes in Europe, Orange guide in UK, WHO in rest of the world and so on. For a company of a global standard complying to all the regulations where it markets its product individually is an extremely onerous task and complicates its quality system too. This requires a harmonized approach to one quality system that fits to all the norms. In order to do this, it is important for a company to design a common platform to lay its standards, execute and then it is important to understand the stage at which they are in complying with these standards.

“Write what you do and do what you have written” are golden words in GxP compliance. Assessment of these words though is fairly complicated, runs through a stepwise approach in checking around 800 Standard Operating Procedures (SOPs) in a typical Pharma plant, each SOP running into several pages and steps. Most companies use an internal audit program as dip stick to measure the level of compliance. This however is a sample based check and can miss vital over trivial if not performed by an experienced auditor. It also has some level of variable outcome on assessment from auditor to auditor.

Companies also use various metric to understand where they stand in respect of key metrics on compliance. Key metrics are however individually tracked and do not give an overall inference on a company’s compliance. What it measures is an intangible sense of compliance. This often lead to a pitfall in compliance focus and surprises during regulatory audit leading to import alert or statement of non-compliance leading to high business and reputation impact as well as non-availability of product to the patients.

Therefore there is a need for a tangible value that can sense compliance risk and obtain the required attention from the quality point of view. It also enables channelizing the attention to where it is needed. Additionally it comes as a ready reckoner to preparing for any regulatory inspections. The inventors of the present invention have provided a quality tool to obtain this quantitative measurement.

Summary of the Invention
In an aspect, the present invention relates to a quality tool (PREDICTTM) used for predicting audit or inspection outcome at pharmaceutical manufacturing sites, wherein measurement is based on intangible data and the outcome is useful to interpret the probable outcome of regulatory inspections at a site.

In another aspect, the present invention provides a method of evaluation (PREDICTTM) of the site score of a pharmaceutical manufacturing site, wherein the predicted outcome comprises of three elements; first element or audit score (System score) being assessment of GMP system compliance via check points based on 132 vital parameters, second element being SME readiness, which integrates aspects of SME readiness at pharmaceutical manufacturing sites and the third element being data integrity compliance scores of pharmaceutical manufacturing site.

In another aspect, the present invention provides the method, wherein the 132 parameters of the first element are categorized into three levels namely Patient Risk (Level-I), Product Quality Risk (Level-II) and Compliance Risk (Level-III).

In another aspect, the present invention provides a method of assessing the first element or audit score as described herein.

In yet another aspect, the present invention provides a method of assessing the second element or the SME readiness as described herein.

In a further aspect, the present invention provides a method of assessing the third element or data integrity compliance by providing a score in percentage (%) based on evaluating compliance level at the site with regards to regulatory requirements (163 parameters) and also level of automation (Mainly in Quality control, Quality Assurance and Production department) at each pharmaceutical manufacturing sites.

In another aspect, the present invention provides a method of evaluating site score of a pharmaceutical manufacturing site, wherein the predicted outcome is determined by compilation of GMP audit score(system score), SME score and data integrity compliance score of the site.

These and other aspects and advantages of the present invention will be apparent to those skilled in the art from the following description.

Brief Description of Drawings of the Invention
Figure 1 - Schematic representation of PredictTM Outcome Model.
Figure 2 - Schematic representation for system score (Audit score) (First element)
Figure 3 - PredictTM Interpretation and Outcome
Figure 4 - Schematic process flow representation of Audit score (System Score)
Figure 5 - PredictTM Outcome of Example 1
Figure 6 - PredictTM Outcome of Example 2
Figure 7 - PredictTM Outcome of Example 3
Figure 8 - PredictTM Outcome of Example 4

Detailed Description of the Invention
It should be understood that the detailed description and specific examples, while indicating embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art. One skilled in the art, based upon the description herein, may utilize the present invention to its fullest extent. The following specific embodiments are to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs.

Definitions
For the purpose of the disclosure, listed below are definitions of various terms used to describe the present invention. Unless otherwise indicated, these definitions apply to the terms as they are used throughout the specification and the appended claims, either individually or as part of a larger group. They should not be interpreted in the literal sense. They are not general definitions and are relevant only for this application.

It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise.

It should be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.

In an embodiment, there is provided a quality tool (PREDICTTM) used for predicting audit/inspection outcome at pharmaceutical manufacturing sites, wherein measurement is based on intangible data and the outcome is useful to interpret the probable outcome of regulatory inspections at a pharmaceutical manufacturing site.

In an embodiment, there is provided a method of evaluation (PREDICTTM) of the site score of a pharmaceutical manufacturing site, wherein the predicted outcome comprises of three elements:
1. The first element or audit score assesses the GMP six system compliance via check points. These check points are based on 132 vital parameters with varying criticality based on patient risk, product risk and pharmaceutical GMP risk linked to FDA’s six systems.
2. The second element is SME readiness. It further integrates aspects of SME readiness at sites which is key for successful audit outcome.
3. The third element is data integrity compliance scores as data integrity (DI) forms integral part of good quality system.
All three elements together form basis of predicting audit outcome. PredictTM outcome is combination of tangible and intangible data providing visibility to management on what would be outcome if audit /inspection is triggered at sites.

In an embodiment, the six systems of the first element are selected from the group consisting of:
(i) Facility And Equipment System,
(ii) Laboratory Control System,
(iii) Material System,
(iv) Packaging and Labelling System,
(v) Production System, and
(vi) Quality Management Systems.

In an embodiment, the Facility And Equipment System comprises of the parameters selected from the group consisting of:
1. Equipment cleaning and sanitization,
2. Prevention of cross-contamination, isolation and containment,
3. Air handling systems,
4. Appropriate use of equipment operations substances,
5. Calibration program,
6. Clean rooms control, maintenance and cleaning,
7. Control system for implementing changes in the equipment,
8. Documented investigation into any unexpected discrepancy,
9. Environmental zoning,
10. Equipment surfaces should not be reactive, additive, or absorptive,
11. Facilities Maintenance,
12. Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) of facilities, utilities and equipment,
13. Informational Technology Good Manufacturing Practices (IT GMP), validation and security,
14. Planned preventive maintenance program,
15. Adequacy of equipment design, size, and location,
16. Design guidelines,
17. Equipment identification practices,
18. Facilities Cleaning,
19. Layout & drawings,
20. Lighting, potable water, washing and toilet facilities, sewage and refuse disposal,
21. Pest control,
22. Sanitation of the building,
23. Technical / Design files, and
24. Zone Ownership.

In an embodiment, the Laboratory Control System comprises of the parameters selected from the group consisting of:
1. Laboratory methods, standards and controls,
2. Qualification and Validation of all QC methods,
3. Qualification of all Laboratory Equipment,
4. Raw data definition, standards, control and verification,
5. Reference standards management,
6. Retained samples, requirements and management,
7. Specifications, standards, and sampling plans,
8. Stability testing,
9. Acceptance Activities and in-process release,
10. Adequacy of equipment and facility for intended use,
11. OOS & Out of trend (OOT) Investigations,
12. Sample handling, storage, and integrity,
13. Test data review and authorization,
14. Validation and security of computerized or automated processes,
15. Adequacy of staffing for laboratory operations,
16. Calibration program,
17. Equipment List,
18. Maintenance program,
19. Method validation policy and standards, and
20. Trending, reporting, and statistical quality control.

In an embodiment, the Material System comprises of the parameters selected from the group consisting of:
1. Bill of Materials,
2. Environmentally controlled storage conditions,
3. Finished product distribution records by lot,
4. Identification & Quality Status,
5. Lot traceability of components making up a batch,
6. Purified Water system control,
7. Specifications and acceptance testing of raw materials,
8. API, excipient, reagent and reference material control,
9. Control of quarantine goods,
10. Control of reject goods,
11. Expiry dating and retest requirements,
12. Incoming goods acceptance checks,
13. Lot numbering control,
14. Pack Range Control – Artwork, components, pack codes,
15. Qualification of cold chain or supply chain,
16. Reconciliation,
17. Reprocessing / rework control,
18. Sampling plan,
19. Supplier management,
20. Authority to Destroy and destruction of records,
21. Control of Distributors, records, Technical Agreements,
22. Control of returned or salvaged goods,
23. Inventory Management,
24. Raw materials segregation and labeling,
25. Testing or validation of supplier's test results for components, containers and closures, and
26. Warehouse controls and First-in-first-out (FIFO).

In an embodiment, the Packaging and Labelling System comprises of the parameters selected from the group consisting of:
1. Adequate inspection (proofing) of incoming labeling,
2. Control of bulk and unlabelled product,
3. Examination of the labeled finished product,
4. In-process inspection of product,
5. Master Packaging Instructions and Records,
6. QA In-process control checks for labeling / packaging operations,
7. Specifications for packaging & labeling materials,
8. Conformance to tamper-evident packaging (TEP) requirements,
9. Controls and management of packaging operations,
10. Line clearance, inspection, and documentation,
11. Product segregation and labeling,
12. Sampling plan and acceptance operations for packaging and labeling materials,
13. Storage, issue, inspection and reconciliation of labels and printed materials, returns after issue,
14. Validation and security of computerized / automated labeling/packaging processes,
15. Validation of packaging and labeling operation,
16. Control of issuance of labeling, examination of issued labels and reconciliation of used labels,
17. Monitoring of printing devices, and
18. Physical/spatial separation between different labeling and packaging lines.

In an embodiment, the Production System comprises of the parameters selected from the group consisting of:
1. Component cleaning validation,
2. Dispensary operations,
3. Equipment cleaning & use logs,
4. In process controls,
5. In-process and final product specifications,
6. Justification and consistency of in-process specifications and drug product final specifications,
7. Key manufacturing processes,
8. Master Manufacturing Instructions and Records,
9. Process validation,
10. Process validation (including CSV and security of computerized /automated processes),
11. Validation of homogeneity,
12. Validation of shelf life (stability testing),
13. Adequate procedure and practice for charge-in of components,
14. Development products manufacture and controls (Technology Transfer),
15. Environmental monitoring,
16. Gowning regimes and requirements,
17. Personnel entry qualification,
18. Personnel hygiene & medical fitness,
19. Pre-process checks, line clearance, and equipment cleaning,
20. Yield calculations and acceptance limits at critical process stages,
21. Control of microbiological spoilage,
22. Facility cleaning validation,
23. Identity of equipment contents, phase of manufacture/status, and
24. Process descriptions (by process).

In an embodiment, the Quality Management Systems comprises of the parameters selected from the group consisting of:
1. Adverse Drug Event (ADE) Management,
2. Annual Product Review, controls charts and summary,
3. Batch manufacturing record/Batch packing record (BMR/BPR) reviews ,approval, archival and retrieval,
4. Customer complaint management,
5. Management of CAPA (FAR, FAR closure and concomitant CAPA),
6. Non-conforming materials, root cause investigation and impact assessment,
7. Previous regulatory observation closure, Establishment Inspection Report (EIR) and Regulatory compliance,
8. Recall Management,
9. Risk assessment and Mitigation Plans,
10. Stability programme management,
11. Technology transfer,
12. Validation management including Validation master plan (VMP) and Quality peer review,
13. Change control (In plant modification, material handling, packaging & labelling etc.),
14. Deviation Management (product, process & utilities),
15. Product disposition,
16. Quality audits and auditing,
17. Documentation management, Record management and Archive – check for data traceability and real time recordings, alignment of e-copies and respective hard copies generated,
18. Management Review and Escalation procedure,
19. Quality Planning, and
20. Training & Qualification Management.

In an embodiment, each of the parameters is categorized into three levels namely Patient Risk (Level-I), Product Quality Risk (Level-II) and Compliance Risk (Level-III). For instance, the parameter “Training & Qualification Management” is categorized into Compliance Risk level while the parameter “Product segregation and labeling” is categorized into Product Quality Risk level” and “Prevention of cross-contamination, isolation and containment” is categorized into Patient Risk.

In an embodiment, there is provided a method to evaluate the audit readiness of a pharmaceutical manufacturing site via an Audit score card (System score) comprising quantification of each of the 132 parameters, based on level of compliance, each of the 132 parameters are assigned with ratings on a scale of 0 to 4 wherein:
• 0 signifies “No process available”,
• 1 signifies “Non-compliant process”,
• 2 signifies “Partially compliant process”,
• 3 signifies “Compliant with improvements” and,
• 4 signifies “Highly compliant process”.

As illustrations:
- All parameters which are classified as Level - I can be assigned a scoring of ‘0’, ‘3’ or ‘4’ based on the level of compliance as defined herein above.
- All parameters which are classified as Level - II can be assigned a scoring of ‘0’, ‘2’, ‘3’ or ‘4’ based on the level of compliance as defined herein above.
- All parameters which are classified as Level - III can be assigned a scoring of ‘0’, ‘1’, ‘2’, ‘3’ or ‘4’, based on the level of compliance as defined herein above.

In an embodiment, each of the 132 parameters are associated with a weightage (%) based on its relevance to patient (highest weightage), product and compliance; providing a rating (from 0 to 4) to each of the parameters and obtaining the audit score for each of the parameters as a product of weightage and the rating. The final audit score would be an average of the individual scores.

Considering the factors indicated above, each of the manufacturing site will perform their assessment and provide ratings based on the level of compliance, the scores will then be validated during corporate audits. Scores computed by corporate auditor will be considered as final and resultant score would be on a scale of 1 to 24. The determination of site being audit compliant is based on the scores wherein:
(i) Scores ranging from above 22 - 24 indicates that the site is highly compliant.
(ii) Scores ranging from above 18-22 indicates that the site is compliant with scope of improvement;
(iii) Scores ranging from 14-18 indicates that the site is partially compliant with gaps; and
(iv) Scores less than 14 indicate that the site is non complaint.
(v) Scoring is done on scale of 1 to 24 and score is interpreted as depicted in Figure 2.

In an embodiment, there is provided a method, wherein the first element is assessed according to the steps comprising of:
(i) associating each of the 132 parameters with a weightage (%) based on its relevance to patient (highest weightage), product and compliance;
(ii) providing a rating to each of the parameters;
(iii) obtaining the audit score for each of the parameters as a product of weightage and the rating; and
(iv) obtaining the final audit score on a scale of 1 to 24 as an average of the individual scores wherein:
a) Scores ranging from above 22 - 24 indicates that the site is highly compliant.
b) Scores ranging from above 18-22 indicates that the site is compliant with scope of improvement;
c) Scores ranging from 14-18 indicates that the site is partially compliant with gaps; and
d) Scores less than 14 indicate that the site is non complaint.

In an embodiment, the second element provides for Subject Matter Expert (SME), evaluated and scored by corporate auditors based on the performance of site during corporate audit. The scoring criteria for SME level are defined as follows:-
a) “0” Need major change in SME at all levels including quality
b) “1” Few critical SMEs (audit facing) in quality requires replacement.
c) “2” Few critical SME ( audit facing) within other 5 systems requires replacement
d) “3” Challenge only with 1 or 2 SME (audit facing) which can be bridged by other competent staff under or at Peer level.
e) “4” Gap in Quality SME ( audit facing) but can be trained
f) “5” Gap in few other SMEs ( audit facing) but can be trained
g) “6” SME ( mainly Quality) require extensive level of audit facing training while possessing requisite knowledge
h) “7” SME (mainly but not only quality) require major level of strategic audit facing training.
i) “8” SME (mainly but not only quality) require low level of audit facing training.
j) “9” SME (mainly quality) requires only incidence related direction or guidance during audit to defend our case as required by regulation during inspection when required.
k) “10” SME (mainly quality) is self-sufficient in changing the course of inspection in our favour due to strong regulatory knowledge and negotiation capability.

In an embodiment, the third element provides for scores from Data Integrity (DI) compliance and provides percentage compliance level at each site with regards to regulatory requirements (163 parameters) and also level of automation (Mainly in Quality control, Quality Assurance and Production department) at each pharmaceutical manufacturing sites.

In a further embodiment the predicted outcome is determined by compilation of Audit score (system score), SME score & DI score of respective site. Interpretation of sites outcome and scores is depicted in Figure 3.

Based on compilation of the scores in Figure 3, predict outcome is interpreted as provided in Table 1.
Table 1
PredictTM Interpretation
Predict Outcome Predict Score Observation Severity Number & category Regulations
Red (Poor) 1 High Double digit WL/483
Critical/RUA FDA
EU/MHRA
Yellow
(Moderate) 3 Moderate = 7 483,
No critical,
Major: Several or category A type FDA
EU/MHRA
Light Green
(Good) 4 Low = 3 483,
No critical, Major: Few FDA
EU/MHRA
Dark Green
(Excellent) 5 Continuous Improvement or non-systemic gaps 0-2 483
No critical/No Major FDA
EU/MHRA

Examples

Example 1:
The score of site “A” for Quality tools are on lower side as per table 2, where audit score observed is poor and site is non-compliant against the six system requirement. Also few SME are found less competent during audit facing but can be trained and DI score observed is on lower side as below:-
Table 2
Quality Tool Scores of Site A
Audit Score 14
DI Score 51
SME Score 5
The result is depicted in Figure 5.

Predict Interpretation of Site A based on Figure 5:
Based on the computation of above scores of quality tool, the outcome of site A for regulatory audit is predicted poor (Red block) and with double digit WL/483 can be interpreted. This weak condition of site A can be improved by mainly focusing on improvement in six system compliance, training the SME in relevant subject and by increasing compliance of DI score.

Example 2:
The score of site “A” for Quality tools are improvised as per table 3, where audit score observed is moderate and site is partially compliant with gaps against the six system requirement. Also SME ( mainly Quality) require extensive level of audit facing training while possessing requisite knowledge and DI score observed at moderate side as below:-
Table 3
Quality Tool Scores of Site A
Audit Score 16
DI Score 65
SME Score 6
The result is depicted in Figure 6.

Predict Interpretation of Site A based on Figure 6:
Based on the computation of above scores, the outcome for site A for regulatory audit is predicted moderate (Yellow block) and less than seven 483 can be interpreted with no critical observation. This can be improved by mainly focusing on improvement in six system compliance, training the SME in respective subject and by increasing compliance of DI score.
Example 3:
The score of site “A” for Quality tools are with some improvements as per table 4, where audit score is observed to be good and site is compliant with scope of improvement against the six system requirement. Also SME (mainly but not only quality) require low level of audit facing training and DI score observed at above qualifying level as below:-
Table 4
Quality Tool Scores of Site A
Audit Score 19
DI Score 75
SME Score 8
The result is depicted in Figure 7.

Predict Interpretation of Site A based on Figure 7:
Based on the computation of above scores, the outcome for site A for regulatory audit is predicted good (light green) and less than three 483 can be interpreted with no critical and few major observation. This can be improved by mainly focusing on improvement in six system compliance, training the SME in audit facing and by increasing compliance of DI score.
Example 4:
The score of site “A” for Quality tools are with some improvements as per table 5, where audit score observed is excellent and site is highly compliant against the six system requirement. Also SME (mainly quality) requires only incidence related direction or guidance during audit to defend our case as required by regulation during inspection when required and DI score observed at good complaint level as below:-
Table 5
Quality Tool Scores of Site A
Audit Score 23
DI Score 94
SME Score 9
The result is depicted in Figure 8.

Predict Interpretation of Site A based on Figure 8:
Based on the computation of above scores, the outcome for site A for regulatory audit is predicted excellent (dark green) and less than two 483 can be interpreted with no critical and no major observation.