audit checklist

AUDIT CHECKLIST

I. Organization

A. ManagementThe key to the management of quality lies in objectives and organizational structure. Corporate policy should include the broad principles common to good quality programs. The organizational structure should clearly define the line of authority and responsibility for quality.

1. How well does corporate policy/objectives provide for effective quality control?

2. How well does the organizational structure define quality responsibility and authority?

3. How well is the QA/QC unit organizationally separate from the unit performing the manufacturing operations?

4. Is there an adequate ratio of management personnel to manufacturing personnel?

5. How well does the organizational structure provide for access to top management?

6. How well does the company self audit for quality, including documentation and follow up audits?

7. How well is the audit information used to define and implement corrective action?

II.FacilitiesThe manufacturing, inspection, and all areas of the facility must be well designed, organized and clean. Equipment must be maintained and environmental controls employed.

1. How clean are the facility (storage, manufacturing, and inspection) areas?

2. How clean are areas of the facility (offices, restrooms, break rooms, etc.)?

3. How adequate are procedures for cleaning, sanitation, and pest control?

4. How well are they followed?

5. Do the major areas have space to do the job required?

6. How organized do the major areas appear to be?

7. How well does the construction and placement and installation of equipment appear?

8. How adequate are procedures for equipment cleaning and maintenance?


10. How adequate and available are records of past maintenance?

11. How adequate are procedures/protocols for equipment qualification and validation?


13. How adequate are procedures for environmental controls (control of lighting, ventilation, temperature and humidity)?


III. Quality Systems

A. Quality DataQuality data (records of all inspections, evaluations and validations performed) should be periodically analyzed and used as a basis for action. It can be used to identify problems and trends, change processes, evaluate the effectiveness of corrective action and improve product quality.

1. How well are records of inspections, evaluations and validations maintained?

2. How well is the quality data used as a basis for action?

3. How well is the quality data used in furnishing “certificates of quality” to customers?

4. How well is the quality data used in the design of specifications for new products?

5. How well are quality programs, trends and results reported to upper management?

B. Documentation Control and Record Keeping Control of documentation is essential for the control of product. The operators and inspectors need complete instructions (e.g., drawings, specs, procedures, change notices, P0 requirements, etc.) in order to make and inspect the product. There must be a system in place to ensure that obsolete and superseded documents are not available for use.

1. How adequate are procedures, which cover the release, change, and superseding of all documentation?


3. How well do records reflect the incorporation of changes?

4. How well are documents stored and available for use?

5. How well are master records and/or history files maintained?

6. How well are complaint files maintained?

7. How well is access to original documentation files controlled?

8. How well is data retention maintained?

9. How well does corporate control?

C. Training/ Personnel Trained personnel in adequate numbers are needed to produce a quality product. Adherence to corporate policies and GMPs regarding cleanliness, garments and personal habits is essential.

1. How well does it appear that there are an adequate number of people to do the job (whole plant)?

2. How well does it appear that there are an adequate number of QC personnel?

3. How adequate are procedures governing the training of personnel?


5. How well are training sessions documented?

6. How well do people adhere to policies regarding cleanliness, personal habits (i.e., smoking) and wearing of proper garments/uniforms?

Comments:

IV. Manufacturing

A. Calibration Periodic inspection and calibration of tools, gages, testers, and equipment is vital to the production of a quality product. Inaccurate measuring instruments may lead to the acceptance of defective material.

1. How adequate are the calibration procedures


3. How adequate is the amount of calibration done on each piece of equipment?

4. How well do standards conform/trace back to National Standards?

5. How suitable are the tools/equipment used based on their intended use?

6. How well is the computer software validated?

B. Procurement and Materials A good quality end product necessitates having incoming materials of the same good quality. Suppliers should be monitored and incoming materials inspected to assure that requirements have been met. Further, materials must be identified and controlled throughout storage and use.

1. How well are suppliers evaluated and monitored?

2. How well are quality requirements specified?

3. How adequate are procedures for receipt, storage and movement of material?


5. How well are materials in storage identified and controlled?

6. How well are materials in stock/storage rotated?

7. How well are materials in inspection identified and controlled?

8. How well are materials in manufacturing (in-process) identified and controlled?

9. How adequate are storage areas and facilities?

10. How well is access to materials controlled?

11. How adequate are procedures for the prevention of damage, deterioration, and corrosion?


13. How adequate are procedures for incoming inspection?


15. How adequate is the incoming inspection of area and equipment?

16. How complete are incoming inspection reports/files?

17. How adequate are the certificates of compliance, which are used in place of inspection?

18. How well are inspection results used for corrective action?

19. How well is nonconforming material identified and controlled?

Comments:

C. Processing In-process inspection, whether by the operators or by QC inspectors, is one of the best ways to achieve a quality product. Many quality characteristics cannot be evaluated in the end product and therefore must be verified during the production process.

1. How adequate are the in-process procedures and/or process specifications?


3. How adequate are the inspection areas and equipment?

4. How complete are in-process inspection reports/files?


6. How well are process capabilities established and maintained?

7. How adequate are the procedures for review and processing?


9. How well are labels controlled?

Comments:

D. Final InspectionFinal inspection and testing are necessary to ensure the acceptability of the product. Rejections at the finished level should be investigated thoroughly and corrective actions implemented.

1. How adequate are the procedures used for the final inspection of finished product?


3. How well are certifications and in-process inspection records used in the final acceptance decisions?


5. How well are finished goods rejections investigated?

Comments:

E. Distribution 1. How is the traceability of the material/product maintained throughout the distribution chain?

2. Are there appropriate controls in the distribution chain to allow product

recall if required?

3. Is product reconciliation maintained throughout the distribution chain?

4. Who owns the various segments of the distribution supply chain?

5. What are the notification steps in the event of a distribution/supply failure and compromise?

6. Who is responsible for investigating distribution/supply chain issues?

Comments:

V. LaboratoryThe laboratory’s responsibility is to ensure the product manufactured is of the appropriate quality and efficacy.

1. How adequate is the GLP SOP?

2. Tour the lab. Is the lab clean and neat with enough space for the number of personnel using the lab as well as adequate space for the equipment necessary to perform testing required?

3. Review the reference standards SOP. How well is the procedure followed in reference to storage of the standards and labeling?

4. Review calibration and maintenance of lab equipment SOP. How well is the procedure followed when maintenance and calibration records of lab equipment are reviewed?

5. Are there specifications available for raw materials, in process materials and finished product? Review test records for raw materials, in process materials and finished product. Are records complete and do they satisfy the requirements of the specifications?

6. Are reagents used in the lab within expiry date? How is expiry date determined if not by the manufacturer?

7. Review equipment qualifications. Are the qualification records up to date and complete?

8. Are reserve samples of raw materials and finished product kept? Are finished product reserve samples stored under conditions specified by the product label?

9. Review lab investigations SOP. How well is the SOP followed with regards to client notification, timely closeout and CAPA resolution?

Comments:

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