AUDITING OF QUALITY ASSURANCE AND ENGINEERING DEPARTMENT.pptx

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 Definition Need of Auditing Objectives of QA Auditing Guidelines for QA Auditing Audit format and approaches QA Audit Checklist 2

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. 3

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 . 4

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 5

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. 6

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 . 7

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 9

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 10

11. QA Audit Checklist S- SATISFACTORY P-PARTIALLY SATISFACTORY I- INADEQUATE 1).SOP 11

12. 2) Personnel 12

13. 3) Deviation Reports 13

14. Webster's dictionary defines maintenance as: • To maintain. • Keep in existing condition. • Reserve or protect. •Keep from failure decline. The ultimate goal of maintenance is to provide optional reliability that meets the business needs of the company. Here "reliability" refers to the probability of failure free performance under stated condition. After understanding the meaning of maintenance, let's now see how a proactive maintenance function works. 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 14

15. Auditing the Maintenance Function The Literature Survey points out nine main sections of maintenance to be audited. The organization of maintenance function or department. Status of qualification and experience of maintenance staff and their performance. Corrective maintenance and management. Tools and other technical instrument needed for specific maintenance work, which depends on the nature of industry-specific needs. Replacement management of equipment parts and equipment itself, which is also known as "planned absolute of equipment“ . 15

16. Maintenance plans-development and implementation. Procedures: existence, structure, actual implementation. The management of information, reports and indication of performance. 9. Result of audit and corrective actions, needed and taken. 16

17. There Are two maintenance approaches namely: 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. 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. 17

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: Analysis of various documents. Interview of technicians in maintenance departments and discussion with maintenance engineers and senior maintenance staff. 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. Visits to actual production and other facilities to which services of the maintenance department are offered. 18

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 . 19

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. 20

21. REFERENCE Textbook of Audit and Regulatory compliance , Dr. Prem R.Goel ,Prof . Manohar Potdar , S imran shaikh , Nirali prakashan , first editon ,page no. 5.1-5.5 T ext book of Audit and Regulatory Compliance , Dr.Rageeb , Dr . Pranita , Prerana Publisher , PV Publication . Auditing of Quality assurance &Maintenance, PPT by, Priyanka Kandhare , aissms cop, 6april2020. Manual on Quality Assurance Programme Auditing, Manual from International Atomic Energy Agency, https://inis.iaea.org Audit Checklist For QA Maintainenece Dept,by Pharmaguddu , https://pharmaguddu.com Quality Audit Introduction, ccs university , https://ccsuniversity.ac.in 21

22. THANK YOU Email :[email protected] 22