Example of procedure for Preventive Action


The purpose of the procedure is:

  • To determine and implement preventive actions, both internally and within the supply chain.
  • To eliminate the causes of non-conformities in-order to minimize the likelihood of its recurrence.


This procedure is applicable to all the following systems and standards

  • ISO 29001:2020/ API Spec Q1, 9th edition
  • API Spec …..
  • API Spec …..
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  • Management representative
  • All concerned process owners


  1. The Management determines action to eliminate the causes to potential nonconformities in order to prevent their occurrence.
  2. Preventive Actions are appropriate to the effects of the potential problems.
  3. The preventive action requires the following:
    • Identifying the areas of improvement.
    • The effective handling of customer complaints and reports of actual non-conformances.
    • Reviewing of nonconformities including customer complaints.
    • Determining potential nonconformities and their causes.
    • Evaluating the need for action to prevent occurrence of nonconformities.
    • Determining and implementing action needed.
    • Identifying the timeframe and responsible person(s) for implementing a preventive action.
    • Preventive actions are implemented to prevent and eliminate non-conformance to a degree, appropriate to the magnitude of problems and commensurate to the risks encountered.
    • Records of the results of action taken.
    • Reviewing the effectiveness of preventive action taken.
    • MOC when the preventive actions require new or changed controls within the Quality Management System.
  4. Preventive actions which are implemented are monitored and audited by the Management Representative & Quality Systems Manager to assess the effectiveness of the action taken.
  5. Records of Preventive Actions taken are maintained and retained for five years.

4.1 Effectiveness Review on Preventive Action:

  1. In XXX, effectiveness of the Preventive action taken is reviewed through a NC closure verification checklist.
  2. Management Representative reviews effectively and may insist for more action, if required. This activity is subject to further evaluation at the time of the Management Review.

4.2 Areas of responsibility:

  1. The management and all employee of the respective location are responsible for introducing preventive action in the company
  2. All employees in departments, which influence product quality are obliged to:
    • Identify and eliminate potential non conformities
    • Introduce effective preventive measures and show that these are effective

4.3 Source of information:

  1. It is necessary for appropriate sources of information to be checked so that potential cause of discrepancy can be recognised, analysed and eliminated.
  2. Such sources are:
    • Quality data from processes
    • Data and trends from goods inwards inspection
    • Data on scrap material
    • Data on rework
    • Results of intermediary and final inspection and checking
    • Results of system, procedure and process audits
  3. The Management Representative/Quality Systems Managereither carry out these checks himself or organise and assess them
  4. Common problem solving methodologies like QC story, Fish-Bone diagrams are used to solve the problems.
  5. The results of the problem solving methodology are documented appropriately by concerned personnel and these documents are subject to verification during MRM.


    Customer Complaint RecordXXX / QA / 14QA/QC Engineer
    Non conformance Product ReportXXX / QA / 42QA/QC Engineer
    Non conformance ReportXXX / MR / 09Management Representative
    Preventive Action RequestXXX / MR / 17Management Representative

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