Your Federal Quarterly Tax Payments are due April 15th Get Help Now >>

Corrective and Preventive Action (CAPA) Procedure by odq14517

VIEWS: 504 PAGES: 6

									       -1

                             Corrective and Preventive Action (CAPA) Procedure                                                  Page 1 of 6
Prepared By: L. Fellner                                                                                              Approved By: C. Harvin
Issue Date: 10/2006                                                                                                  Revised Date: 03/2010
Document Number: QP-06                                                                                               Revision Number: 8




                                                             Table of Contents



            Scope......................................................................................................... page 2

            Job Responsibilities .................................................................................. page 2

            Corrective Action Process ........................................................................ page 3

            Preventive Action Process ........................................................................ page 4

            Revision History ....................................................................................... page 6




Disclaimer: This document contains proprietary information to Ace World Wide and may not be used or disclosed to
others, except with the written permission of Ace World Wide.

Master documents are available on the AWW intranet as controlled documents. Any paper copy of this document
will be considered uncontrolled.
         -2

                        Corrective and Preventive Action (CAPA) Procedure                     Page 2 of 6
Prepared By: L. Fellner                                                               Approved By: C. Harvin
Issue Date: 10/2006                                                                   Revised Date: 03/2010
Document Number: QP-06                                                                Revision Number: 8


Scope:

This procedure defines the process that AWW will use to define, initiate, approve and close all corrective
or preventive actions for the business to continuously improve the quality objectives and the quality
management system. The procedure will also define the timing and documentation needed to ensure that
actions taken have been completed and are effective.

Job Responsibilities:

   1. Management Representative has the responsibility ensure that data is analyzed and corrective or
      preventive action is taken according to this procedure. The Management Representative also has the
      responsibility to verify closure of actions taken and assign and verify effectiveness checks.

   2. Operations Managers have the responsibility to ensure this procedure is understood and followed by
      all employees.

   3. Employees have the responsibility to understand this procedure in the event they are assigned to
      assist in a corrective or preventive action.




Disclaimer: This document contains proprietary information to Ace World Wide and may not be used or disclosed to
others, except with the written permission of Ace World Wide.

Master documents are available on the AWW intranet as controlled documents. Any paper copy of this document
will be considered uncontrolled.
       -3

                        Corrective and Preventive Action (CAPA) Procedure                     Page 3 of 6
Prepared By: L. Fellner                                                               Approved By: C. Harvin
Issue Date: 10/2006                                                                   Revised Date: 03/2010
Document Number: QP-06                                                                Revision Number: 8

Corrective Action Process

   1. Corrective actions can be initiated by anyone who detects a quality issue that needs immediate
      attention, or is initiated by triggered corrective action criteria.

   2. Corrective actions initiated by triggered corrective action criteria are a result of data analysis of the
      various processes in the quality system. These processes include:

            a. Internal and External Audits – Any finding or nonconformance found during an audit, this is
               further defined in the Internal Audit Procedure QP-03.

            b. Management Reviews – Any finding determined during the review, this is further defined in
               section 5.6 of the AWW Quality Manual.

            c. Customer Complaints – Corrective actions are issued based on the priority and frequency of
               complaint as defined in the Customer Complaint Procedure QP-05.

            d. Nonconforming Material – Any NCR issued determined to be caused by Ace.
               NOTE: NCR’s that have the same categorization can be consolidated into one CAR if
               within a 3-month period of time.

            e. Process Audits – Monthly Cycle Count accuracy percentage less than 95% (Defects), or
               monthly percentage of a single error summary is greater than 0.75% for combined
               modalities.

            f. Inspection Activities (RAIF, PAIF, and AAIF) – Monthly accuracy percentage less than
               95% (Defects), or monthly percentage of a single error summary is greater than 4% for
               combined modalities.

            g. Pick to Ship Cycle Time – If cycle time exceeds 3 days due to AWW fault for 3 orders in
               one month.

            h. Supplier Defects – 3 similar supplier defects for 1 supplier in the same category, this is
               further defined in the Purchasing Process Procedure QP-10.

   3. Corrective action that is not initiated by corrective action criteria can be presented in writing or
      verbally to an Operations Manager or the Management Representative. The request will be
      reviewed by the Management Representative to determine if it is suitable for a corrective action.




Disclaimer: This document contains proprietary information to Ace World Wide and may not be used or disclosed to
others, except with the written permission of Ace World Wide.

Master documents are available on the AWW intranet as controlled documents. Any paper copy of this document
will be considered uncontrolled.
       -4

                        Corrective and Preventive Action (CAPA) Procedure                     Page 4 of 6
Prepared By: L. Fellner                                                               Approved By: C. Harvin
Issue Date: 10/2006                                                                   Revised Date: 03/2010
Document Number: QP-06                                                                Revision Number: 8

   4. Once the need for corrective action is determined, a Corrective Action Request (CAR) Form F-06 is
      initiated and a team is assigned. The team is given 30 days to determine root cause and identify an
      action plan and assign due dates to each action item.

   5. Upon completion of each action item, evidence for that action item will be turned in to the
      Management Representative to ensure that the CAR is being carried out as planned. If any action
      item is not acceptable or the evidence is not satisfactory to satisfy any action item, the Management
      Representative will go over the changes needed with the responsible individuals to correct any
      discrepancies. After successful completion of all action items, the Management Representative will
      review and approve.

   6. The Management Representative and the CAR team will determine and document how the
      effectiveness will be determined. Effectiveness means that the actions taken have eliminated the
      nonconformance.

   7. If the effectiveness check comes back unsuccessful, the CAR will remain open and another round of
      effectiveness will be performed. If the second round of effectiveness check still comes back
      unsuccessful, the managers and the management representative will review the CAR and determine
      what changes are needed. This may include modifying the root cause or modifying or adding action
      items to the CAR.

   8. After decided changes have been added to the CAR and completed, another effectiveness check will
      be done. The process for verifying effectiveness is repeated until the effectiveness has been
      satisfied. The Management Representative will then approve the effectiveness check and close the
      CAR.


Preventive Action Process

   1. Preventive actions are initiated to prevent the occurrence of potential nonconformities and can be
      initiated by anyone who detects a process improvement opportunity within the organization.
      Preventive actions may be but are not limited to:

            a. Implementing new equipment or software

            b. Simplifying a process

            c. Six sigma projects

            d. Internal and ISO Audit Observations


Disclaimer: This document contains proprietary information to Ace World Wide and may not be used or disclosed to
others, except with the written permission of Ace World Wide.

Master documents are available on the AWW intranet as controlled documents. Any paper copy of this document
will be considered uncontrolled.
       -5

                        Corrective and Preventive Action (CAPA) Procedure                     Page 5 of 6
Prepared By: L. Fellner                                                               Approved By: C. Harvin
Issue Date: 10/2006                                                                   Revised Date: 03/2010
Document Number: QP-06                                                                Revision Number: 8

   2. The request will be reviewed by the Management Representative to determine if it is suitable for a
      preventive action (i.e., what are we preventing from happening? How much money and/or time are
      we saving, how will it make work easier/more efficient?). If approved, a Preventive Action Request
      (PAR) Form F-67 is initiated and a team is assigned to come up with a preventive action plan and
      assign due dates to each action item.

   3. Upon completion of each action item, evidence for that action item will be turned in to the
      Management Representative to ensure that the PAR is being carried out as planned. If any action
      item is not acceptable or the evidence is not satisfactory to satisfy any action item, the Management
      Representative will go over the changes needed with the responsible individuals to correct any
      discrepancies. After successful completion of all action items, the Management Representative will
      review and approve.

   4. The Management Representative and the PAR team will determine and document how the
      effectiveness will be determined. Effectiveness means that the actions taken have resulted in
      expected benefits of implementation.

   5. If the effectiveness check comes back unsuccessful, the PAR will remain open and another round of
      effectiveness will be performed. If the second round of effectiveness check still comes back
      unsuccessful, the managers and the management representative will review the PAR and determine
      what changes are needed. This may include modifying or adding action items to the PAR.

   6. After decided changes have been added to the PAR and completed, another effectiveness check will
      be done. The process for verifying effectiveness is repeated until the effectiveness has been
      satisfied. The Management Representative will then approve the effectiveness check and close the
      PAR.




Disclaimer: This document contains proprietary information to Ace World Wide and may not be used or disclosed to
others, except with the written permission of Ace World Wide.

Master documents are available on the AWW intranet as controlled documents. Any paper copy of this document
will be considered uncontrolled.
       -6

                        Corrective and Preventive Action (CAPA) Procedure                     Page 6 of 6
Prepared By: L. Fellner                                                               Approved By: C. Harvin
Issue Date: 10/2006                                                                   Revised Date: 03/2010
Document Number: QP-06                                                                Revision Number: 8

                                               Revision History


Rev     Date          Author                          Approver                     Reason for Change
 0     10/2006 R. Samant                       C. Givens                               Original Issue
 1     05/2007 R. Samant                       C. Harvin                       Dropped error percentage:
                                                                              - 0.75% for Process Audits
                                                                                   - 4% for Inspections
 2     10/2007 R. Samant                       C. Harvin                          Added details to CAR
                                                                                       assignment as
                                                                            Corrective/Preventive in point
                                                                                              5.
 3     04/2008 R. Samant                       M. Vlaj                        - Changed Corrective action
                                                                                  criteria for inspection
                                                                              activities to say that a CAR
                                                                            will be done if one modality’s
                                                                            percentage falls less than 95%
                                                                            for three consecutive months.
                                                                                   - Added definition of
                                                                              corrective and preventative
                                                                                           action.
 4     06/2008 R. Samant                       M. Vlaj                           -Took out definitions of
                                                                                corrective and preventive
                                                                                      action (point 1).
 5     02/2009 A. Rodriguez                    M. Vlaj                         - Reviewed procedure and
                                                                             incorporated needed updates
                                                                              - Changed responsibility of
                                                                               CAR from person to team.
 6     08/2009 L. Lockwood                     C. Harvin                            - Point 5 - Clarified
                                                                            identification of a “preventive
                                                                                           action”
 7     12/2009 L. Fellner                      C. Harvin                     - Separated “Preventive” and
                                                                            “Corrective” action processes
                                                                                 - Clarified definition of
                                                                                     preventive action
 8     03/2010 L. Fellner                      C. Harvin                      Added a note in 2.d. stating
                                                                               that similar NCR’s can be
                                                                                consolidated into 1 CAR




Disclaimer: This document contains proprietary information to Ace World Wide and may not be used or disclosed to
others, except with the written permission of Ace World Wide.

Master documents are available on the AWW intranet as controlled documents. Any paper copy of this document
will be considered uncontrolled.

								
To top