2008-QOP-85-02 – Corrective and Preventive Action

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QMS Operational Procedure

QOP-85-02
Section 8.5 Section Revision: A Revision Date: 7/12/2010
Corrective and Preventive Action
Approved By: Todd Gifford Date: 7/12/2010

PURPOSE

The intent of this procedure is to describe the process at Dee Electronics for Corrective and Preventive Action (Section 8.5.2 and 8.5.3 of ISO 9001:2008).

The overall Responsibility and Authority for activities relating to this element of the standard have been assigned to the President. Team Members are charged with the responsibility to implement the procedure as written, and have been granted appropriate freedom and authority to do so.

APPLICATION

This process pertains to all aspects of the quality system at Dee Electronic; it is not restricted to product-related concerns or nonconformities. Process and system nonconformities are also provided for.

PROCEDURE

  1. The Corrective Action database of ECIS is utilized by team members universally to collect information for improving the effectiveness of the Quality System, such as:
    1. Customer concerns
    2. Inspection and testing results and trends
    3. Internal audit Nonconformances
    4. External audit Nonconformances
    5. Team member concerns
  2. Preventive Actions may be taken by management as a result of successful Corrective Action. When Corrective Action is applied to other Dee Electronics products, processes or locations, it is preventive action. Additional sources for Preventive Action include:
      1. Team member concerns
      2. Management Review ideas
      3. Industry and non-industry Best Practices
      4. Internal and external audit Observations
  3. If there is observable evidence that the problem already exists (Corrective Action called for):
      1. Team Members in the affected area devise a Corrective Action Plan.
      2. Team Members are trained as appropriate.
      3. Team Members implement Corrective Action Plan.  Utiliztion of the following tools is conducted when determining root cause: 5 Why’s and Cause/Effect (Fish Bone) Diagrams.
      4. Quality Control Coordinator and President follow up and determine the effectiveness of the CA.
      5. President revises documentation as necessary, maintains records and reports to management in Management Review.
  4. If there is no observable problem but there is a potential that one may exist in the near future (Preventive Action called for):
      1. President and affected Team Members brainstorm preventative solution(s).
      2. President proposes Preventive Action in Management Review moves ahead with implementation as appropriate.
      3. Quality practices, documented procedures, processes and forms are revised as needed.
      4. President revises and reissues quality system documentation, as necessary.
      5. Management provides necessary resources.
      6. Team Members are trained as appropriate.
      7. Team Members implement Preventive Action.
      8. President determines effectiveness of Preventive Action and reports during Management Review or prior if appropriate.
      9. President maintains records of Preventive Action in Internal Audit/Management Corrective/Preventive Action Form QF-82-02-01.
  5. Corrective and Preventive Actions are continuously assessed by:
      1. Internal quality audits.
      2. External quality audits.
      3. Feedback from Team Members.
      4. Feedback from Customers.
  6. The President and MR maintain electronic records (ECIS) related to Corrective and Preventive Action. See QOP-42-03, Control of Records, for retention details.
  7. Continual Improvement – Continual improvement actions are often defined as corrective and preventive actions.  This is especially true for preventive actions.  Operational Procedure QOP-85-01, Continual Improvement, and QOP-56-01, Management Review, explain how the corrective and preventive action system is used for facilitating continual improvement.
  8. The effectiveness of Corrective Action and Preventative Action taken is reviewed by ongoing statistical analysis (prompting for review of effectiveness of Corrective Actions and Preventative Actions) as well as reviewed in Management Review Meetings by reviewing Corrective Action and Preventative Action trending.  Records of these reviews are maintained in QF-85-02-01 and in the Management Review Meeting minutes.

ASSOCIATED DOCUMENTS

QF-56-01-01 Quality Form: Management Review Minutes

QF-85-01-01 Quality Form: Online Employee Feedback/Concern Form

QF-72-02-02 Quality Form: Online Customer Concern/Complaint/Feedback Form

QF-85-02-01 Quality Form: Corrective Action CAR/RMA Form

QF-82-02-01 Quality Form: Internal Audit/Management Corrective/Preventive Action Form

QOP-83-01 Operational Procedure: Control of Nonconforming Product

QOP-72-02 Operational Procedure: Customer Feedback and Complaints

QOP-85-01 Operational Procedure: Continual Improvement