Quality Audit and Supplier Audits
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Questions and Answers

What is the main goal of GMP manufacturing audits?

  • To reduce variability in the quality of final product
  • To manufacture a product that consistently meets specifications (correct)
  • To demonstrate a proactive approach to process improvement
  • To uncover inaccuracies in production processes

    • What is an outcome of implementing GMP manufacturing audits?

  • Increase in variability in the quality of final product
  • Decrease in the production of acceptable products
  • Uncontrolled change in production processes
  • Improvement in product stability (correct)

    • What is not a focus of GMP manufacturing audits?

  • Product control
  • Quality control
  • Financial control (correct)
  • Process control

    • What is a benefit of implementing GMP manufacturing audits?

    <p>Demonstrate a proactive approach to process improvement</p> Signup and view all the answers

    What is an outcome of regular GMP manufacturing audits?

    <p>Uncovering of inaccuracies</p> Signup and view all the answers

    What is a key aspect of GMP manufacturing audits?

    <p>Ensure production of acceptable products at each step of the production process</p> Signup and view all the answers

    What is the primary purpose of a quality audit?

    <p>To improve the quality system</p> Signup and view all the answers

    What is the purpose of self-inspection in a company?

    <p>To evaluate whether a company's operations remain compliant with GMP</p> Signup and view all the answers

    What should a self-inspection program cover?

    <p>All GMP requirements, especially on production and quality control</p> Signup and view all the answers

    When should a self-inspection be performed?

    <p>Routinely on events such as product recalls and repeated rejections</p> Signup and view all the answers

    Who should be part of the self-inspection team?

    <p>Personnel who can evaluate the situation objectively and have no conflict of interest</p> Signup and view all the answers

    What should be included in a self-inspection report?

    <p>Results, evaluation, conclusions, and recommended corrective measures</p> Signup and view all the answers

    What is the role of the QC department in supplier audits?

    <p>To evaluate suppliers and approve them before they are included in approved suppliers' lists</p> Signup and view all the answers

    What should be taken into account when evaluating suppliers?

    <p>Both the supplier's history and nature of materials to be supplied</p> Signup and view all the answers

    What is the first step in planning an audit?

    <p>Identify the purpose and scope of the audit</p> Signup and view all the answers

    What should be considered when selecting a manufacturing process to audit?

    <p>The process with ongoing record of problems</p> Signup and view all the answers

    What should be done with problems discovered during an audit?

    <p>Document them and inform all those affected</p> Signup and view all the answers

    What is a Sanitation Standard Operating Procedure (SSOP) document?

    <p>A document that describes procedures to ensure cleaning and sanitation activities are performed correctly</p> Signup and view all the answers

    What are analytical control procedures used for?

    <p>To adapt methods to a company's needs while ensuring accuracy and replication</p> Signup and view all the answers

    What is a risk deviation?

    <p>A manufacturing process deviation that could result in the production of a product not meeting its quality objectives</p> Signup and view all the answers

    What should be monitored after an audit?

    <p>The corrective action results</p> Signup and view all the answers

    What should be included in an audit plan?

    <p>The purpose and scope of the audit, auditee and units to be audited, audit team members, and standard being audited against</p> Signup and view all the answers

    What is a non-risk deviation?

    <p>A manufacturing process deviation that is unlikely to result in an off-quality product</p> Signup and view all the answers

    What is the purpose of an audit?

    <p>To identify areas for improvement in manufacturing processes</p> Signup and view all the answers

    What is the primary goal of manufacturing audits?

    <p>To assist in the resolution of problems found in the process</p> Signup and view all the answers

    What is required for a complete manufacturing audit?

    <p>Complete understanding of process, equipment, and specifications</p> Signup and view all the answers

    What is one of the unit operations to be considered in a manufacturing audit?

    <p>CONTROLLING- valves, thermometers, scales, etc.</p> Signup and view all the answers

    What is the purpose of emphasizing good practices in manufacturing audits?

    <p>To put value on good practices</p> Signup and view all the answers

    What is meant to be assisted in a manufacturing audit?

    <p>The resolution of problems found in the process</p> Signup and view all the answers

    What is the relationship between manufacturing audits and process problems?

    <p>Manufacturing audits are meant to resolve process problems</p> Signup and view all the answers

    What is included in the unit operations to be considered in a manufacturing audit?

    <p>All of the above including SEPARATION OF SOLIDS FROM LIQUIDS</p> Signup and view all the answers

    What is the purpose of prioritizing corrective actions in a manufacturing audit?

    <p>To assist in the resolution of problems found in the process</p> Signup and view all the answers

    Study Notes

    Quality Audit

    • A quality audit is an examination and assessment of all or part of a quality system with the specific purpose of improving it.
    • Quality audits can be conducted by internal or external audit teams.
    • Audits may also be extended to suppliers and contractors, if necessary.
    • A report should be made at the completion of each quality audit.

    World Health Organization (WHO) Principles on Self-Inspection

    • The purpose of self-inspection is to:
      • Evaluate whether a company's operations remain compliant with GMP
      • Assist in ensuring quality improvement
    • A self-inspection program should:
      • Cover all GMP requirements, particularly on production and quality control
      • Have written instructions that provide minimum and uniform standards
      • Be designed to detect shortcomings in the implementation of GMP
      • Recommend corrective actions
      • Set a timetable for corrective action to be completed
    • Self-inspection should be performed routinely on events such as product recalls, repeated rejections, or when a GMP inspection is announced by the national food regulatory authority.
    • A self-inspection team should consist of personnel who:
      • Can evaluate the situation objectively
      • Have no conflict of interest
      • Have experience as observers of a self-inspection team before becoming a team member
      • Can lead the self-inspection team if they have experience as a team member already
    • An effective follow-up program should be implemented, and the procedure should be documented.

    Supplier's Audit

    • The QC department should have responsibility, together with other relevant departments, for approving suppliers.
    • Suppliers should be evaluated and approved before they are included in approved suppliers' lists.
    • The evaluation should take into account the supplier's history and nature of materials to be supplied.

    Manufacturing Audits

    • The purpose of manufacturing audits is to:
      • Manufacture a product that consistently meets specifications
      • Ensure the production of acceptable products at each step of the production process
      • Improve product stability
      • Reduce variability in the quality of the final product and in the processing steps
      • Uncover inaccuracies
      • Encourage ongoing corrective action
      • Demonstrate a proactive approach to process improvement
    • Focus areas for manufacturing audits include:
      • Process control
      • Unit operations to be considered, such as cleaning, disintegration, evaporating, heating, separation of solids from liquids, drying, materials handling, packaging, and mixing
    • Requirements for manufacturing audits include:
      • Complete understanding of process, equipment, and specifications

    Steps in Process Control Audits

    • Planning the audit:
      • Identify purpose and scope of audit
      • Identify auditee and units to be audited
      • Identify audit team members
      • Identify standard being audited against
      • Determine date and place of audit, duration of audit, and date of release of results
    • Selecting the manufacturing process to audit:
      • Consider processes with history of success, but it is preferable to audit first the process that has an ongoing record of problems
    • Deciding who will conduct the audit:
      • Audit team members should be familiar with the process and have audit experience
    • Deciding the frequency of the audit:
      • Determine the frequency of the audit based on the process and its history
    • Recording the audit schedule:
      • Record the audit schedule on a form
    • Conducting the audit:
      • Conduct the audit according to the audit schedule
    • Documenting problems:
      • Document problems discovered during the audit
    • Informing all those affected:
      • Inform all those affected by the audit results
    • Monitoring corrective action results:
      • Monitor corrective action results and implement changes as necessary

    Areas to Consider When Auditing

    • Product-specific manufacturing procedures
    • Standard sanitary operation procedures (SSOP)
    • Analytical control procedures
    • Product-dependent operations
    • Product-independent operations

    Audit Deviations

    • Risk deviations:
      • Deviations from risk requirements
      • Practices that could result in the production, nondetection, or prolonged manufacture of a product not meeting its quality objectives
    • Non-risk deviations:
      • Manufacturing process deviations not categorized as risk deviations
      • Substitute procedures used by the plant, provided that the procedure is not likely to result in the production or nondetection of an off-quality product or decrease in safety

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    Description

    This quiz covers the basics of quality audit, including its purpose, types, and reports. It also extends to audits of suppliers and contractors, as per FDA Philippines guidelines.

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