CAPA Procedure

-1 Corrective and Preventive Action (CAPA) Procedure Prepared Prepare d By: L. Fellner Issue Date: 10/2006 Document Docume nt Number: QP-06

Page 1 of 6 Approved By: C. Harvin Revised Date: 03/2010 Revision Number: Nu mber: 8

Table of Contents

Scope................................................................................... Scope............................ ............................................................................. ...................... page 2 Job Responsibilities Responsibilities .................................................. ................................ page 2 Corrective Action Process .................................................. ...................... page 3 Preventi Preve ntive ve Action Process Proce ss.................................................. .................................................. ...................... page 4 Revision Revision History ........................................................ ....................................................................................... ............................... page 6

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-2 Corrective and Preventive Action (CAPA) Procedure Prepared By: L. Fellner Issue Date: 10/2006 Document Number: QP-06

Page 2 of 6 Approved By: C. Harvin Revised Date: 03/2010 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.




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 a ction 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 nonconfor mance 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 de fined 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 cyc le 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.




4. Once the need for corrective action is determined, a Corrective Act ion 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 tha t 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 Re presentative 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 de termine 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




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 tha t 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.




Revision History

Rev 0 1

Date 10/2006 05/2007

Author R. Samant R. Samant

Approver C. Givens C. Harvin

2

10/2007

R. Samant

C. Harvin

3

04/2008

R. Samant

M. Vlaj

4

06/2008

R. Samant

M. Vlaj

5

02/2009

A. Rodriguez

M. Vlaj

6

08/2009

L. Lockwood

C. Harvin

7

12/2009

L. Fellner

C. Harvin

8

03/2010

L. Fellner

C. Harvin

Reason for Change Original Issue Dropped error percentage: - 0.75% for Process Audits - 4% for Inspections Added details to CAR assignment as Corrective/Preventive in point 5. - 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. -Took out definitions of corrective and preventive action (point 1). - Reviewed procedure and incorporated needed updates - Changed responsibility of CAR from person to team. - Point 5 - Clarified identification of a “preventive action” - Separated “Preventive” and “Corrective” action processes - Clarified definition of preventive action Added a note in 2.d. stating that similar NCR’s can be consolidated into 1 CAR


CAPA Procedure

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