This Slideshare Contain a Brief information about the How Auditing Of QA Department is considered and followed in the Industry to get . Desired Quality product throughout the all production step and in the batch . Objective importance and Advantages of QA Auditing are explained here. In this slide for giving out and detailed study About it .

1. AUDITING OF QUALITY ASSURANCE
MAINTENANCE DEPARTMENT
PRESENTED BY
MAIND SHANKAR
M.PHARM (QA)
GUIDED BY
MS. POOJA LANKE
ASS. PROFESSOR AISSMS COP ,PUNE
Date :13/06/2023

2. Index
1) Definition
2) Need of Auditing
3) Objectives of QA Auditing
4) Guidelines for QA Auditing
5) Audit format and approaches
6) QA Audit Checklist
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3. Definition
• “A quality assurance audit is a documented ,systematic process
,performed in a planned manner by competent independent personnel
with the objectives of evaluating the application by an organization to the
principles and requirements of defined quality regulations and customer
expectations”
• The word independent is very important here , and is used in the sense
that the Reviewer (Auditors) is neither the person responsible for the
performance under review nor the immediate supervisor of that person .
• An independant audit provides an unbiased (Clear) picture of
performance.
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4. Need of Auditing
• Both the quality assurance department and the Engineering department
service industries and auditing of service industries to the pharmaceutical
industry is considered as critical .
• The engineering department is considerd as the heart of the pharmaceutical
industry and if there are problems with heart industry may not be able perform
up to its optimal potential .
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5. Objectives of Auditing Quality
Assurance
• An audit is a "benchmarking process", i.e. an audit will give a status of the current
performance of a process. This status can be measured against a published standard,
or an approved operating procedure.
• The audit may identify shortcomings in process performance, changing trends in
performance, deficiencies in staff knowledge or competence. Any such findings can
be concidered for improvement activities.
• Deficiencies are identified any corrective actions are taken .
• A key point to understand as part of the audit program, is the potential for learning
and knowledge transfer during the audit process .
• By explaining the reasons for particular requirements, or test points, or record
requirements, the person being audited can personally develop their process or
product knowledge.
• Regulatory and standard compliance
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6. Conti..
• Quality assurance auditing is a concept widely used in internal, external and
customer audits for measuring QA within the enterprise.
• The greater challenge is ensuring that procedures correctly mirror documented
standards. Because a single document or research cycle for any mfg. product can
result in abundance of documents and forms, companies establish QA departments
to ensure process quality can be maintained.
• Its important to regularly audit the QA procedures so that the management can
evaluate the efficiency of these procedures.
• A large amount of QA work involves in-process tests and on-line inspections that
should be audited along with the specific departments.
• The purpose of this audit is to evaluate the overall operation of the QA unit &, in
particular, those functions that, by their nature, are not included in other
departmental audits.
• The goal of QA audit, then, is to continually improve and ultimately, build
confidence in your product.
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7. Guidelines for QA Auditing
• This audit refer specifically to one or more paragraphs of 21 CFR 211.
• SOPS should be reviewed for conformity with the requirements of 21 CFR.
• Irrespective of the response, select a batch with a deviation report attached
and check that the batch was not released prior to satisfactory resolution of
the problem, including QA approval.
• If no such batches are observed, but there is no written procedure, a
satisfactory procedure may actually be in place, but should be formalized in
a company SOP.
• There should be a checklist for batch record release to ensure that the
person releasing the batch has actually reviewed all the necessary
documents prior to release.
• QA is responsible for ensuring that deviations are thoroughly investigated
are documented so proper care have to taken .
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8. Audit Format and Approaches
So, the basic premise is that "A quality product can only be produced and
distributed by:
Quality inputs
Quality process
Hence, Quality Assurance Audit should be checked for the quality of all inputs,
processes and also confirm that the output i.e., the finished pharmaceutical
product also meets the desired quality specifications and requirements of the
ultimate customer or uses of the finished product“
*Questioning Theory:
It says; the auditors should ask questions about every "Input" and "Process" to
satisfy himself about their quality e.g.;
How?
What?
When?
Where?
Who?
Why?

9. • Ask as many questions as you think needed, without hesitation to
see that the minimum quality of all inputs and processes is
satisfactorily met.
The range of questions should cover following and many other areas as
well e.g.:
• Personnel
• Buildings
• Equipment
• Systems
• Processes
• Quality control
• Manufacturing
• Validation
• Outsourcing
• Complaints and product returns
• Security Safety and many more
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10. •If the auditors ask questions and satisfied with the answers and proofs of their
answers by documentation system or any other way.
•The audit should normally be called satisfactory.
•In short, the manufacturer does the activities to produce a quality finished
product and the auditor verifies the manufacturer has actually done all those using
appropriate inputs and hence the finished product produced by him can assure the
quality of the product to the ultimate customer and sees that the customer is not
only satisfied but delighted.
•The actual entire audit process has been described in detail with a detailed
questionnaire
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11. QA Audit Checklist S- SATISFACTORY
P-PARTIALLY SATISFACTORY
I- INADEQUATE
1).SOP
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12. 2) Personnel
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13. 3) Deviation Reports
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14. Webster's dictionary defines maintenance as:
• To maintain.
• Keep in existing condition.
• Reserve or protect.
•Keep from failure decline.
1. The ultimate goal of maintenance is to provide optional reliability that
meets the business needs of the company.
2. Here "reliability" refers to the probability of failure free performance under
stated condition.
3. After understanding the meaning of maintenance, let's now see how a
proactive maintenance function works.
4. John Day a noted proactive maintenance advocate and management expert
says, maintenance is a strategy to achieve world-class production through
reliability.
Audit Of Maintenance Department
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15. Auditing the Maintenance Function
• The Literature Survey points out nine main sections of
maintenance to be audited.
1. The organization of maintenance function or department.
2. Status of qualification and experience of maintenance
staff and their performance.
3. Corrective maintenance and management.
4. Tools and other technical instrument needed for specific
maintenance work, which depends on the nature of
industry-specific needs.
5. Replacement management of equipment parts and
equipment itself, which is also known as "planned
absolute of equipment“ .
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16. 6. Maintenance plans-development and implementation.
7. Procedures: existence, structure, actual implementation.
8. The management of information, reports and indication of
performance.
9. Result of audit and corrective actions, needed and taken.
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17. There Are two maintenance
approaches namely:
(a) Reactive Maintenance System (RMS): RMS responds to a work request or
identified need, usually production identified and depends on rapid response
measure if effective. The goals of this abstract are to reduce response time to a
minimum and to reduce equipment downtime to an acceptable level.
• This is the approach used by most operations today including pharmaceutical
manufacturing environment. It may incorporate what is termed as preventive
maintenance programme and may use proactive technologies.
(a) Proactive Maintenance System (PMS): PMS responds priority to equipment
assessment and predictive procedures. The overwhelming majority of corrective,
preventive and modification work is generated internally in the maintenance
function as a result of inspection and predictive procedures.
• The goals of this method are continuous equipment maintenance specification,
maintenance of productive capacity and continuous improvement.
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18. The main objective of an audit of maintenance department is to
identify those areas of potential optimization and proposed
organizational and maintenance resource changes that will make
the function more effective.
Maintenance of audit is based on:
(a) Analysis of various documents.
(b) Interview of technicians in maintenance departments and
discussion with maintenance engineers and senior maintenance
staff.
(c) Sometimes views of production and other department personnel
is also taken into account as part of maintenance department
audits so see the customer satisfaction evaluation.
(d) Visits to actual production and other facilities to which services of
the maintenance department are offered.
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19. A good maintenance audit helps in
 Determining whether management of the main aspects of maintenance
(e.g., spare parts, change parts, personnel, work method, safety tools,
time and cost analysis of maintenance, etc.) is adequate.
 Analysis of down time will help in production.
 Scheduling department to make production schedules more reliable.
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20. Common issues often defeated in
maintenance audit
 Unsuitable organization structure of department (e.g. excess or lack
of staff).
 Training deficit (lack of staff training).
 Bad structuring (especially no staff present at key moments).
 Shortage of spares.
 Lack of inventory or over inventory.
 Lack of key tools .
 Maintenance store badly organized and lack of space.
 No preventive maintenance plans.
 Inadequate preventive maintenance plans.
 Lack of awareness on the use of personnel protective equipment.
 In short, Audit of maintenance is very important and useful in any
pharmaceutical Organization.
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21. REFERENCE
1. Textbook of Audit and Regulatory compliance , Dr. Prem R.Goel
,Prof .Manohar Potdar ,Simran shaikh ,Nirali prakashan, first editon
,page no. 5.1-5.5
2. Text book of Audit and Regulatory Compliance , Dr.Rageeb , Dr.
Pranita , Prerana Publisher , PV Publication .
3. Auditing of Quality assurance &Maintenance, PPT by, Priyanka
Kandhare, aissms cop, 6april2020.
4. Manual on Quality Assurance Programme Auditing, Manual from
International Atomic Energy Agency, https://inis.iaea.org
5. Audit Checklist For QA Maintainenece Dept,by Pharmaguddu,
https://pharmaguddu.com
6. Quality Audit Introduction, ccs university , https://ccsuniversity.ac.in
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22. Email :shankarpatil8485@gmail.com
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