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Auditing of quality assurance and maintenance of engineering department

Auditing of quality assurance and maintenance of engineering department , Audit checklist of quality assurance, Audit checklist for maintenance

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1
Definition
• “A quality assurance audit is a documented, systematic process,
performed in a planned manner by competent independent
personnel with the objective of evaluating the application by an
organization to the principles and requirements of defined
quality regulations and customer expectations”.
2
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, may identify changing trends in
performance, may identify deficiencies in staff knowledge or competence. Any such findings can then
become the basis for improvement activities.
• A key point to understand as part of the audit program, is the potential for learning and knowledge
transfer during the audit process. Where the auditor has a good understanding of the product or
process, he / she can use the audit as a form of training for the person being audited. 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
3
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.
4
Conti...
• 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.
5
Audit Format and Approaches
Manual GMP audit methods can be divided into categorie
Checklist format
GMP regulation approach
6
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Auditing of quality assurance and maintenance of engineering department

  • 2. Definition • “A quality assurance audit is a documented, systematic process, performed in a planned manner by competent independent personnel with the objective of evaluating the application by an organization to the principles and requirements of defined quality regulations and customer expectations”. 2
  • 3. 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, may identify changing trends in performance, may identify deficiencies in staff knowledge or competence. Any such findings can then become the basis for improvement activities. • A key point to understand as part of the audit program, is the potential for learning and knowledge transfer during the audit process. Where the auditor has a good understanding of the product or process, he / she can use the audit as a form of training for the person being audited. 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 3
  • 4. 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. 4
  • 5. Conti... • 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. 5
  • 6. Audit Format and Approaches Manual GMP audit methods can be divided into categorie Checklist format GMP regulation approach 6
  • 7. Checklist Format • Use checklist as GMP audit guides and reporting finding. • Series of questions or instructions are grouped in to logical order. • Blocks may be used to record answer and space may be provided to make comments. 7
  • 8. AUDIT CHECKLIST OF QUALITY ASSURANCE 8
  • 9. CHECKLIST KEY S= Satisfactory P= Partially Satisfactory I= Inadequate 1.SOPs 9
  • 10. a) up-to-date training records b) Trained under GMPs, SOPs, QAT or not c) Knowledgeable about their job functions d) Qualification relevant to the SOP e) Attiring appropriate garmenting SOP f) Checking given job description g) Up-to-date organizational chart 2.Personnel 10
  • 11. a) SOP prior to release b) Checklist prior to release c) Tracking procedure d) Batch examination i) True copy of master formula ii) Any changes to master formula iii) Present relevant signs iv) Present relevant data v) Relevant data accuracy vi) Yield calculation at each stage vii) Calculation verification viii) justification, explanation and authorization of deviations 3.Batch Record Review 11
  • 12. a) MDRs prepared within the last 6 months 1)Manufacturing deviation reports completion 2) Investigation and follow-up of SOP 3) MDRs filled out with the SOP 4) Documented investigation 5) Prevention of deviation recurring 6) Recommendation for corrective action b) Daily deviation reports c) Summarization of deviations 4.Deviation Reports 12
  • 22. Maintenance of Engineering Department • Any operation that is performed by the maintenance or engineering department must be covered by a written procedure. • Calibration records should be relatively easy to audit. • First, for each type of instrument, there should be a procedure detailing how the calibration is to be performed, what standard equipment is to used, and what deviation is permitted. • There should also be recommended corrective action to be taken if the deviation is exceeded. 22
  • 23. Conti.... • Examine several calibration forms and compare the recorded data with the requirement of SOP. • Calibration is probably the most exacting science practiced in the facility; accurate recording of figures essential. Overwriting figures is not acceptable since it inevitably leads to lack of clarity. • Preventive maintenance records should be reviewed together with breakdown records. If a piece of equipment is constantly breaking down, the preventive maintenance schedule may need to be revised. It is possible that if serviced more frequently, the breakdowns could be prevented. 23
  • 24. Audit Checklist for Maintenance 24
  • 25. CHECKLIST KEY S= Satisfactory P= Partially Satisfactory I= Inadequate 1.SOPs 25
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  • 33. 10.Receipt of New Equipment 33
  • 36. 13.Air Changes Test Records 36
  • 37. 14.Maintenance of Tablet Punches and Dies 37
  • 38. 38