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Quality audit


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Quality audit

  1. 1.  A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements, and whether these arrangements are implemented effectively and are suitable to achieve objectives 2
  2. 2.  To collect objective evidence to permit an informed judgment about the status of the systems or product being audited 3
  3. 3.  Internal (First Party, Self)  This type includes audits by company employees, consultants and contractors 5
  4. 4.  External i. Supplier Audit ○ Second Party  Customer employee(s) audit your company or  Your employee(s) audit a company which supplies your company with a product or service 6
  5. 5. ii. Independent Organization  Third Party Audit ○ A customer wants an audit of your company 7
  6. 6. 1. Compliance (do we comply with the standard)  Example: Desk audit of high level systems2. System (the theory)  Example: Audit of Document Control3. Process (the practice)  Example: Audit of any process (manufacturing)4. Product (the result)  Example: Audit of finished products to fulfil technical specifications 8
  7. 7. 1. Auditor: A person who has appropriate qualifications and performs audits.2. Client: A person or organization requesting the audit. For internal audits, this is the Management Representative.3. Auditee: An organization, facility or person being audited. 9
  8. 8. 4. Quality System: The organizational structure, responsibilities, procedures, processes and resources for implementing quality management.5. Observation: A statement of fact made during an audit and substantiated by objective evidence.6. Nonconformity: The non-fulfillment of specified requirements. 10
  9. 9. 7. Objective Evidence: Qualitative or quantitative information, records or statements of fact pertaining to the quality of an item or service or to the existence and implementation of a quality system element, which is based on observation, measurement or test and which can be verified. 11
  10. 10. (A) Imposed upon manufacturer or supplier Third party (on Customer, orRegulatory behalf of potential customer customer) 12
  11. 11. (B) Performed by manufacturer(i) Internal (self- (ii) External inspection) 13
  12. 12. Internal (self- External inspection)• Overall • supplier• Departmental • contract manufacturer• Product-orientated • contract packager• System-orientated • Of contract warehouse/distributor 14
  13. 13. • Determine the level of compliance• Build confidence (hopefully) in GMP and the QA system• Build interdepartmental trust, understanding, and communication (if the audit is done properly and tactfully)• Determine measures necessary to improve, e.g.,:• Premises, equipment, environment• Operations, actions, procedures• Personnel/training• Provide a stimulus for improvement• Recommend corrective action• Monitor improvement 15
  14. 14. • Establish and monitor capability of supplier or contractor to deliver• goods and services that are fit for purpose (and on time, and in the quantity required)• Build mutual confidence• Promote understanding and communication between the parties involved (both sides can learn!)• And in general, as listed for “internal” 16
  15. 15. Plan and prepare Arrange and Follow-up announce Arrive at site ofFormal report, with audit, meet, explain recommendations purpose Informal oral Perform report of audit finding 17
  16. 16. 18
  17. 17. examination of1. established methods2. instructions3. work flow for processes4. maintenance programs for production equipment5. material handling6. housekeeping around the work area 19
  18. 18.  Here company’s procedures are validated Processes are sub-parts of a system.  Process audits are generally a part of larger system(s) audit.  However , they can be performed independently ○ An internal audit may indicate need to perform a specific process audit Almost always, one or more other process(es) will interact with any given process. One very important issue to consider is the effectiveness of communications between systems and/or processes. 20
  19. 19. Inter-relation between different processes 21
  20. 20. 1. Documents a. Quality and GMP regulations, standards, and guidelines (local, national, and international) b. Previous audit and follow-up reports c. Auditee’s own documents and records d. Audit checklists  requires that auditor evaluates a certain number of procedures, plans and documents2. The auditors own eyes, ears, brain, words, character, etc.3. The auditing plan 22
  21. 21. 1. Is there a documented sanitation program?2. Are the specifics of the program followed?3. Are there standard operating procedures (SSOPs)?4. Is a pre-operational audit conducted prior to production?5. Are corrective actions taken in response to pre-op findings?6. What are the general conditions in the plant?7. Are the floors, walls and ceilings in good condition?8. Are the exterior structure and grounds maintained in a condition to prevent contamination? 23