IBF
CORRECTIVE AND PREVENTIVE ACTION
IBF-005
Procedure
Approved By
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Name Date
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School Name / Procedure / IBF-005 / Prepared by: Bud CollierTitle: Corrective and Preventive Action / Date: 1/25/12 / Rev. 0 / Page 1 of 6
REVISION LOG
REVISION # / DATE / SECTION / PARAGRAPH0 / 7/1/97 / N/A / N/A
VERIFY THAT THIS IS THE CORRECT VERSION BEFORE USE
IBF / IBF-005Corrective and Preventive Action
Rev. 0 / Page 1 of 7
1.0PURPOSE: The purpose of this quality procedure is to describe the process to document customeractions, corrective actions, and preventive actions.
2.0SCOPE: This quality procedure is applicable to all personnel at the Houston, TX (School) location.
3.0POLICY:
3.1Non-conformities that have or potentially have major impacts on quality-related services, and/orprocesses or consist of a series of related minor non-conformities will be documented using this quality procedure.
3.2For non-conformities that have occurred, a customer action or corrective action non-conformity note (NCN) will be initiated to resolve the non-conformity. The corrective action section of the NCN will be used to document the action(s) taken to correct the non-conformity. The preventive action section of the NCN will be used to document the action(s) taken to prevent the reoccurrence of the non-conformity.
3.3For non-conformities that have not occurred, a preventive action NCN will be initiated to prevent the occurrence of the potential non-conformity. The preventive action section of the NCN will be used to document the action(s) taken to prevent the occurrence of the potential non-conformity.
4.0DEFINITIONS:
4.1Corrective Action – an action taken to eliminate the cause(s) of an existingnon-conformity or undesirable situation.
4.2Customer Action – an action taken to eliminate the cause(s) of an existing non-conformity or undesirable situation as identified by or on behalf of a customer. This can be any written or verbal expression of dissatisfaction related to identity, quality, reliability, safety, or performance of any product, service, and/or process.
4.3Non-conformity – is the inability of a product, service, and/or process to perform to its specified requirements.
4.4Preventive Action– (1) an action taken to prevent the recurrence of an existingnon-conformity or undesirable situation or (2) an action taken to eliminate the cause(s) of a potential non-conformity or undesirable situation in order to prevent occurrence.
4.5Root Cause – a detailed description of the cause of the non-conformity or undesirable situation.
5.0AUTHORITIES AND RESPONSIBILITIES:
5.1The Anti-Bullying Management Representative is responsible for approving and closing customer-related corrective actions, corrective actions, and/or preventive actions..
5.2The Manager(s) is responsible for providing appropriate feedback to the customer.
5.3Corrective Action Panels (CAP) can be established to review and status customer, corrective, and preventive actions.
5.4The Anti-Bullying Management Representativeis responsible for the customer action, corrective action, and preventive action process and for providing appropriate feedback to management and affected departments. The Anti-Bullying Management Representative is also delegated the same approval and closure authority as the Department Manager.
5.5The Anti-Bullying Management Representativeis responsible for documenting, reviewing, tracking the progress of, and maintaining completed customer actions, corrective actions, and preventive actions.The Anti-Bullying Management Representativeis also are responsible for maintaining the corrective action, preventive action (CAPA) database(s).
5.6Managers, when assigned a non-conformity, are responsible for determining the root cause of the non-conformity and preparing and implementing corrective and/or preventive action(s) to resolve the non-conformity. This may include design changes, drawing and document corrections, process changes, personnel training, etc.
6.0PROCESS:
6.1Initiating a Customer Action, Corrective Action, or Preventive Action:
6.1.1A customer action, corrective action, or preventive action can be initiated from the following sources:
Customer identified, either verbal or written
Internal and external quality audits
Customer or 3rd party audits
Self-identified product, service, and/or process non-conformities
Multiple related product, service, and/or process non-conformities
Customer satisfaction interviews and survey results
Note: the initiation of an action is not limited to the examples listed above. In addition, corrective action requirements may be flowed down to a supplier when it is determined that the supplier is responsible for the non-conformity.
6.1.2Any employee can initiate an action.
6.1.3When an action is identified the following information shall be provided to theAnti-Bullying Management Representative.
NCN type: customer, corrective, or preventive
Initiated by
Initiated date
Nature of non-conformity
Responsible area
Received from
Note: if the root cause, corrective action, preventive action, additional non-conforming product, and responsible party are known at the time of the above information, then the initiator or assignee can submit the information.
6.1.4The Anti-Bullying Management Representativewill initiate the action in the CAPA database and indicate its status as “Review”. The following table provides the numbering convention for actions.
NCN Type / Numbering ConventionCustomer / CA-yy-xxx
Corrective / CA-yy-xxx
Preventive / PA-yy-xxx
where, yy is the year (2-digit) the action was initiated and xxx is a sequential number
6.1.5The Anti-Bullying Management Representative will distribute the draft action to the initiator or assignee to complete the following sections of the NCN report:
- root cause
- corrective action (if applicable)
- preventive action
- identification of additional non-conforming product (not required for OMOHC)
The Anti-Bullying Management Representativewill typically request a 5 day turn-around for the responses.
6.1.6When the applicable root cause, corrective action, preventive action, and additional non-conforming product responses are received from the initiator or assignee, A standard 90 day target due date will be assigned unless a longer target due date is negotiated.
6.2Reviewing and Approving a Customer Action, CorrectiveActon, or Preventive Action:
6.2.1Each action will be reviewed, approved, and closed following the table below.
NCN Type / Reviewers / Approvers(includes Closure)Customer Actions / Anti-Bullying Management Representativepersonnel, Program Managers, and/orCAP members /
- Group President(or designee)
- Program Managers(or designee)
- Director of Technical Services/
Corrective Actions Preventive Actions / Anti-Bullying Management RepresentativeISO Administration Section personnel, Program Managers, and/or CAP members /
- Group President(or designee)
- Program Managers (or designee)
- Director of Technical Services/
Note:If an action has been assigned directly (“Responsible for Completion”) to one of the approvers listed in the above table, he/she may not approve or close the action.
6.2.2When responses for the root cause, corrective action, preventive action, and non-conforming product sections of the NCN are completed, ISO Administration Section personnel will conduct a review or submit the draft action for review.
6.2.4When the review of the action is complete, the Anti-Bullying Management Representativewill update the action in the CAPA database, if necessary, and print the NCN report for approval signature (see table for list of approvers).
6.2.5When the NCN report is approved, the Anti-Bullying Management Representativewill change the action status to “Approved” in the CAPA database and list the objective evidence required to close the action.
6.2.6The Anti-Bullying Management Representative will inform managersor personnel assigned the action that it was approved and provide the list of objective evidence required to close the action.
6.3Statusing a Customer Action, Corrective Action, or Preventive Actions:
6.3.1As the action approaches its due date, The Anti-Bullying Management Representative will request objective evidence and target due date status for each approved action from managers assigned the action.
6.3.2As the individual objective evidence is received for each action and deemed to be complete and effective, The Anti-Bullying Management Representativemaystatus the objective evidencein the CAPA database by adding “(complete)”. Changes in target due date will be recorded in the CAPA database and do not require a revision and re-approval of the action.
6.3.3Where timely and/or effective corrective actions are not being achieved, The Anti-Bullying Management Representativewill regularly review established completion metrics with the responsible Program Management (e.g., during monthly management reviews). This notification may lead to the following actions:
- Management’s involvement in directing the owner(s) to address overdue action(s)
- Extending due dates
- Revision of actions
6.3.4The status of customer actions, corrective actions, and preventive actions(including overdue actions) will be discussed in the quarterly quality management reviews. Senior Management involvement in directing the owner(s) toaddress overdue action(s) will be requested as necessary.
6.4Closing a Customer Action, Corrective Action, or Preventive Action: Once all of the submitted objective evidence is submitted and meets ISO Administration Section personnel expectations, the approved action, with the objective evidence attached, will be routed for review and closed by the same authority (or their designee) that approved it. Once the action is closed, the Anti-Bullying Management Representative will change the action status to “Closed” in the CAPA database.
Note: The objective evidence must show the actions were effectively implemented.
6.5Revising a Customer Action, Corrective Action, or Preventive Action:
6.5.1If an action requires a revision to the root cause or corrective or preventive actions, then the action shall be re-approved by the same authority that approved the original action.
6.5.2The initiator of the revision shall contactthe Anti-Bullying Management Representative to initiate the revision process.
6.5.3The original, approved action will be marked as “revised” and attached to the revised, approved action.
6.5.4The revised action will be entered into the CAPA database and revised objective evidence will be documented, if necessary.
7.0TRAINING AND CERTIFICATION: N/A
8.0DOCUMENT CONTROL:
8.1This Work Instruction will be reviewed periodically or as needed. The previous revision will be marked “Obsolete” on the front page and as a minimum the previous revision must be retained
9.0ATTACHMENTS: N/A
10.0REFERENCES:
10.1
VERIFY THAT THIS IS THE CORRECT VERSION BEFORE USE.