Corrective and Preventive Action - DOC - DOC by hcj


									                          QMS Operational Procedure OP-85-03
                             CORRECTIVE AND PREVENTIVE ACTION
                           Eff. Date: 00/00/00                         Rev.: 1   Pg. 1 of 4

      The purpose of this procedure is to provide for a system and instructions, and
      to assign responsibilities for initiating, requesting, implementing, and verifying
      the effectiveness of corrective and preventive actions.

      This procedure applies to preventing and correcting nonconformities related to
      materials, components, subassemblies, finished products, manufacturing
      processes, and the quality system.
      NOTE: Accusonic Products recognizes an important distinction between
      preventive and corrective action in the phase of identifying the problem that
      needs to be corrected or prevented. Accordingly, the present procedure has
      separate sections for handling the two types of actions in this phase (Section 1
      and 2). However, in subsequent phases preventive and corrective actions are
      processed through the same system and both types of actions are referred to
      as corrective actions (Section 3).


1     Corrective actions
1.1   Corrective actions are implemented to address actual nonconformities.
      Initiation of a corrective action request (CAR) may be proposed by anyone in
      the organization, but all CARs must be authorized by Quality Assurance or the
      President. This is to prioritize and direct resources where corrective actions
      are most urgent.

1.2   Requests to initiate a CAR are made in writing to Quality Assurance or, if
      Quality Assurance activities are involved, to the President. The request
      includes a description of the unsatisfactory condition to be corrected and
      explain how quality is affected.

1.3   CARs may be directed to the company's internal departments as well as to its
      suppliers and subcontractors.

1.4   Corrective actions may be requested in the following cases:
       Identification of a nonconforming product;
       Problem with a process or work operation;
       A nonconformity identified during a statutory and regulatory or third-party
        audit (internal audits have their own CAR system);
       Customer or statutory and regulatory complaint;
                Operational Procedure         QOP-85-03       Rev.: 1      Pg. 2 of 4

       Nonconforming delivery from a supplier;
       Identification of any other component, device, process or condition that does
        not conform with specifications, documented quality system, or requirements
        of the ISO 9001 standard or applicable regulations.
2     Preventive actions
2.1   Preventive actions are implemented where there is an increased risk for a
      potential nonconformity. The need for a preventive action is identified on the
      basis of information regarding capability and performance of processes and
      work operations, product nonconformity rates, customer complaints, and
      effectiveness of the quality system.

2.2   Quality Assurance is responsible for collecting, compiling and reviewing the
      pertinent information, to include:
       Reject and scrap rates;
       Product nonconformity reports;
       Production equipment maintenance records;
       Customer complaints; and
       Quality system audit records.
2.3   Preventive actions are initiated when quality performance data indicates that
      there are trends of decreasing quality capability and/or effectiveness of the
      quality system. For example: increasing incidence of product nonconformities
      traceable to the same common cause; excessive equipment problems; or
      increasing number of audit findings against the same element of the quality
      system or department.

2.4   When a problem requiring preventive action is identified, the process of
      dealing with the problem follows the same steps that apply to corrective
      actions, as described in this procedure in Clause 3, Requesting and
      Processing CARs. In subsequent processing stages both types of actions are
      referred to as corrective actions.

3     Requesting and processing CARs (applies also to preventive actions)
3.1   Corrective and preventive actions are requested using the CAR form, a model
      of which is provided in Form F-85-03-1, Corrective Action Request. The
      requests include description of the unsatisfactory condition that needs to be
      corrected and are addressed to the manager responsible for the condition.
      The same CAR form is also used to request corrective actions from suppliers.

3.2   Upon receiving a request for corrective action, the responsible manager
      investigates the cause of the problem that initiated the request, proposes a
      corrective action to be taken, and indicates the date by which the corrective
      action will be fully implemented.
                 Operational Procedure          QOP-85-03         Rev.: 1       Pg. 3 of 4

3.3   The results of the investigation of what caused the nonconformity, and the
      proposed corrective action are documented in the CAR form. The form is then
      forwarded to Quality Assurance or the President for review and approval of the
      proposed action.
             (Approval at this stage is not mandatory but it helps to ensure that the
             proposed actions are indeed relevant and practical, and that there will be
             resources necessary to implement them).
3.4   Any implemented changes are reviewed with respect to their impact on current
      documentation, and the documentation is updated as appropriate.
      Documentation changes are recorded in the CAR form.

3.5   On, or immediately after, the due date for implementation of a corrective
      action, Quality Assurance or the President follows up with an inquiry or an
      audit to determine if the corrective action has been implemented and if it is
      effective. When there is objective evidence that the corrective action is
      effective, the CAR can be closed out. If more work is needed to fully
      implement the action, a new follow-up date is set.

       Form F-85-03-1, Corrective Action Request
       Operational Procedure OP-83-01, Control of Nonconforming Product
       Corrective and preventive action records: Records of corrective and
        preventive actions, and their implementation and closeout. Based on form F-
        85-03-1, Corrective Action Request.
                                                          CORRECTIVE AND PREVENTIVE ACTION
                                              Operational Procedure                              QOP-85-03             Rev.: 1               Pg. 4 of 4

                                         CORRECTIVE/PREVENTIVE ACTION REQUEST                                                         No.:

                                             Date: 00-00-00                                                   Revision: 1              F-85-03-1
Department/Vendor:       You can also use the form for requesting actions from vendors and subcontractors                             Corrective    
Product/Process:                                                                                                                      Preventive    
Documentation:       Use if the action is against, or related to documentation
Originated by: Name/title of the person requesting the action

Date:                                          NONCONFORMING CONDITION
        Originator use this block to describe the nonconforming condition

                                                            Originator (Sign):                         Responsible Manager/Supervisor (Sign):

Date:                                       CORRECTIVE/PREVENTIVE ACTION                                           Due Date:
   Responsible manager/supervisor use this block to propose a corrective action

                                                            Originator (Sign):                         Responsible Manager/Supervisor (Sign):

Due Date:                                        FOLLOW-UP AND CLOSEOUT                                            New Due Date:

Approved       Yes           No  Extension                                    Approved       Yes      No
Evidence Reviewed:                                                               Evidence Reviewed:
Document or reference items and objective evidence
that was reviewed for closeout

Originator (Sign):                                                               Originator (Sign):

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