The objective of this document is to provide guidance in completion of the Corrective Action Response (CAR) Form. You may have received a CAR Form(s) as a result of an audit or investigation involving your area, department, or company. XXXX utilizes the CAR Form to document audit findings as well as the corrective actions utilized to prevent issues from reoccurring. The goal of the CAR is to find system-based improvements as opposed to finding someone to blame. Please ensure all fields of the CAR Form are completed.
If a meeting, training or "Read & Sign” action is used to communicate an issue to personnel, a copy of the meeting minutes, roster of who attended the training or document must be attached. If a plan is put in place to prevent reoccurrence, a description of the plan must be attached. If part of the corrective action is a policy or procedure written or changed, a copy of the vendor manual change must be attached. For internal XXXXXX departments, an unapproved TP-1 may be included with the knowledge that the CAR will remain open until an approved TP-1 is received by QA.
The necessity of determining "Root Cause" is imperative and the most important aspect of your response. What really is at the heart of the problem? Another important aspect is the “Comprehensive Corrective Action” block. What will we do to prevent reoccurrence? Included are instructions for completing the CAR and some examples. You may print this material out for continued reference.
The objective of this document is to provide guidance in completion of the Corrective Action Response (CAR) Form. You may have received a CAR Form(s) as a result of an audit or investigation involving your area, department, or company. XXXX utilizes the CAR Form to document audit findings as well as the corrective actions utilized to prevent issues from reoccurring. The goal of the CAR is to find system-based improvements as opposed to finding someone to blame. Please ensure all fields of the CAR Form are completed.
If a meeting, training or "Read & Sign” action is used to communicate an issue to personnel, a copy of the meeting minutes, roster of who attended the training or document must be attached. If a plan is put in place to prevent reoccurrence, a description of the plan must be attached. If part of the corrective action is a policy or procedure written or changed, a copy of the vendor manual change must be attached. For internal XXXXXX departments, an unapproved TP-1 may be included with the knowledge that the CAR will remain open until an approved TP-1 is received by QA.
The necessity of determining "Root Cause" is imperative and the most important aspect of your response. What really is at the heart of the problem? Another important aspect is the “Comprehensive Corrective Action” block. What will we do to prevent reoccurrence? Included are instructions for completing the CAR and some examples. You may print this material out for continued reference.
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