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Corrective Action Plan Template (WORD VERSION)

This document summarizes an audit report and corrective action plan for a supplier to the pharmaceutical industry. The summary includes information about the audit firm, dates, facility details, audit findings, agreed upon corrective actions and timelines. Site management is asked to sign confirming discussion and understanding of the findings, and whether the report can be shared with PSCI member companies.

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Mbonise Mboja
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208 views3 pages

Corrective Action Plan Template (WORD VERSION)

This document summarizes an audit report and corrective action plan for a supplier to the pharmaceutical industry. The summary includes information about the audit firm, dates, facility details, audit findings, agreed upon corrective actions and timelines. Site management is asked to sign confirming discussion and understanding of the findings, and whether the report can be shared with PSCI member companies.

Uploaded by

Mbonise Mboja
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Pharmaceutical Supply Chain Initiative (PSCI)


Corrective Action Plan Report
for PSCI Audit at Supplier to Pharmaceutical Industry
AUDITOR AND AUDIT REPORT INFORMATION
Report Number:  
Date of audit:   Date and type of
 
previous audit:
Audit Firm Name:
Lead Auditor Name:   Title:  
Names of further
auditors
Phone Number:   Email Address:  
FACILITY DETAILS
Company Name:  
Parent Company Name
(if applicable)  
Street Address:  
State/
City:   Province/  
County:
Postal/Zip Code:   Country:  
Facility Background Information
 API (active pharmaceutical ingredient) manufacture
 Biological manufacture
Please indicate which of the following  Chemical manufacture
 Contract Research Laboratories
best describes this facility (check all  Finished Formulations
that apply):  Logistics / Warehouse
 Primary Packaging
 Other (please describe)

Describe type of work currently being,


or proposed to be, performed at this  
facility, and product type(s):

SITE CONTACT INFORMATION


Site Representative
Name (host):   Title:  
Phone Number:   Email Address:  

Mar 2020 1 Version 2


PSCI Supplier Corrective Action Plan
Findings, Corrective Actions and Follow-up
Finding Finding Type* Description of Finding Agreed Corrective Recommended Verification Agreed by Verification Evidence Status
Number C= Critical Please describe the finding (as done in Actions Completion Method Management and and Comments Open/Closed
The reference O= Other the PSCI Audit Report) Details of actions to be taken Timescale Desktop / Name of Responsible Details on corrective action or comment
number of the Or to follow up on the Finding Timescale Follow-Up Person: evidence
Finding from the C= Critical (Immediate, 30, Visit Note if management agree
Audit Report, 60, 90,180,365 to the Finding, and
for example,
M = Major
days) document name of
Discrimination Mi = Minor
Please indicate responsible person
No.7
finding types

Note:
*Please note that there are two distinct findings classification methods (Critical/Other or Critical/Major/Minor). Once you have selected a method, please be consistent
throughout the audit report and Corrective Action Plan below. If in doubt, please contact the report owner (who is commissioning the audit) to confirm their preferred
method.

Critical Findings: Are very high risk findings that require immediate action to protect human life, the health of employees or the environment; May result in loss of license to operate or
serious damage to reputation; Require immediate corrective action by the supplier; Need to be communicated to the audit sponsor prior to audit report finalization.
Other Findings: Are all other major or minor audit findings, which need to be corrected by the supplier in an appropriate period of time
Major Findings: Findings that may pose major impacts to workers, the community, or the environment. Findings that may pose major regulatory non-compliances or illustrate systemic
program gaps.
Minor Findings: Findings that may pose minor impacts to workers, the community, the environment. Findings that may pose minor regulatory non-compliances.

Mar 2020 2 Version 2


PSCI Supplier Corrective Action Plan
Confirmation
Please sign this document confirming that the above findings have been discussed with and understood by you: (site management)
Site Representative Signature: Name

Title

Date
Auditor Signature: Name

Title

Date
Please indicate below if you, the site management, dispute any of the findings
I dispute the following numbered Findings:
Please indicate if this Audit Report and Corrective Action Plan can be shared with PSCI member companies.
Agree to share the completed Audit Report and Corrective Action Report with all PSCI members: Yes_______No_______
Agree to share completed Audit Report and corrective Action Report with only specific PSCI members: _______________________________________________

Signed: Title

Date
Site Comments:

Mar 2020 3 Version 2

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