Example of procedure for Preventive Action

Uncategorized 2 Minutes

1.0 PURPOSE

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.

2.0 SCOPE

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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3.0 RESPONSIBILITY

  • Management representative
  • All concerned process owners

4.0 PROCEDURE

  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.

    5.0 ASSOCIATED DOCUMENTS & RECORDS

    DESCRIPTIONFORMAT NUMBERRESPONSIBILITY
    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

    Published by Pretesh Biswas

    Pretesh Biswas has wealth of qualifications and experience in providing results-oriented solutions for your system development, training or auditing needs. He has helped dozens of organizations in implementing effective management systems to a number of standards. He provide a unique blend of specialized knowledge, experience, tools and interactive skills to help you develop systems that not only get certified, but also contribute to the bottom line. He has taught literally hundreds of students over the past 5 years. He has experience in training at hundreds of organizations in several industry sectors. His training is unique in that which can be customized as to your management system and activities and deliver them at your facility. This greatly accelerates the learning curve and application of the knowledge acquired. He is now ex-Certification body lead auditor now working as consultancy auditor. He has performed hundreds of audits in several industry sectors. As consultancy auditor, he not just report findings, but provide value-added service in recommending appropriate solutions. Experience Consultancy: He has helped over 100 clients in a wide variety of industries achieve ISO 9001,14001,27001,20000, OHSAS 18001 and TS 16949 certification. Industries include automotive, metal stamping and screw machine, fabrication, machining, assembly, Forging electrostatic and chrome plating, heat-treating, coatings, glass, plastic and rubber products, electrical and electronic equipment, assemblies & components, batteries, computer hardware and software, printing, placement and Security help, warehousing and distribution, repair facilities, consumer credit counseling agencies, banks, call centers, etc. Training: He has delivered public and on-site quality management training to over 1000 students. Courses include ISO/TS -RAB approved Lead Auditor, Internal Auditing, Implementation, Documentation, as well as customized ISO/TS courses, PPAP, FMEA, APQP and Control Plans. Auditing: He has conducted over 100 third party registration and surveillance audits and dozens of gap, internal and pre-assessment audits to ISO/QS/TS Standards, in the manufacturing and service sectors. Other services: He has provided business planning, restructuring, asset management, systems and process streamlining services to a variety of manufacturing and service clients such as printing, plastics, automotive, transportation and custom brokerage, warehousing and distribution, electrical and electronics, trading, equipment leasing, etc. Education & professional certification: Pretesh Biswas has held IRCA certified Lead Auditor for ISO 9001,14001 and 27001. He holds a Bachelor of Engineering degree in Mechanical Engineering and is a MBA in Systems and Marketing. Prior to becoming a business consultant 6 years ago, he has worked in several portfolios such as Marketing, operations, production, Quality and customer care. He is also certified in Six Sigma Black belt .

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