Pharmaceutical Supply Chain Initiative

Corrective Action Plan Report Template

Version 5.0
December 2021

Overview
Guidance for completion
Cells in this colour should be completed by the supplier
Cells in this colour should be completed by the auditor

1. Audit Information
Audit report number:
Report owner:

Date of audit: DD/MM/YYYY

2. Auditor Information
Audit firm name:

3. Facility Details
Company name:
Site name:
Parent company name:
Site street address:
Site city:
Site postal/zip code:
Duns number (9 digit code):

4. Site Contact Information

Site representative name (host):
Phone number:
Management representative name:
HSE representative name:
HR representative name:
5. Findings Summary

Finding classification method Critical/Major/Minor

Section Critical
Management Systems
Ethics
Human Rights & Labor
Environmental Compliance and Risk
Management
Health and Safety Compliance and Risk
Management

Definitions:
Critical Findings: Are very high risk findings that require immediate action to protect human life, the health of em
immediate corrective action by the supplier; Need to be communicated to the audit sponsor prior to audit report f
Major Findings: Findings that may pose major impacts to workers, the community, or the environment. Findings
Minor Findings: Findings that may pose minor impacts to workers, the community, the environment. Findings th
Non-Finding remarks: Are where the auditor wishes to raise an important comment, but this comment would no
Site state/province/county:
Site country:

Title:
Email address:
Title:
Title:
Title:
 Major Minor

ect human life, the health of employees or the environment; May result in loss of license to operate or serious damage to reputation; Re
sponsor prior to audit report finalization.
, or the environment. Findings that may pose major regulatory non-compliances or illustrate systemic program gaps.
, the environment. Findings that may pose minor regulatory non-compliances.
nt, but this comment would not constitute any type of finding.
Guidance notes:

This is the company paying/sponsoring the audit. If a PSCI

Member, the name should be removed before the report is
uploaded to the PSCI audit sharing platform.

If different from company name

If applicable

The person that hosted the audit

If applicable
If applicable
lt in loss of license to operate or serious damage to reputation; Require

ompliances or illustrate systemic program gaps.

pliances.
Corrective Action Plan

Finding number Finding Type

Reference the question number from the audit C= Critical
report where the finding is recorded M = Major
Mi = Minor
Please indicate finding types
Note
It is not possible in an audit, with a limited time frame, to identify every area requiring attention. It is the responsib
the most important buildings, facilities, and EHS topics could be inspected or discussed during the audit.

Critical Findings: Are very high risk findings that require immediate action to protect human life, the health of emp
communicated to the audit sponsor prior to audit report finalization.
Major Findings: Findings that may pose major impacts to workers, the community, or the environment. Findings t
Minor Findings: Findings that may pose minor impacts to workers, the community, the environment. Findings tha

Confirmation

Version 1 - Audit Closing Meeting

Please sign this document confirming that the above findings have been discussed with and un

Site Representative Electronic Signature:

Insert signature

Auditor Electronic Signature:

Insert signature

Please indicate below if you, the site management, dispute any of the findings:

I dispute the following numbered findings:

Version 2

Site Representative Electronic Signature:

Insert signature
PSCI Member Electronic Signature:

Insert signature

Please indicate below if you, the site management, dispute any of the findings:

I dispute the following numbered Findings:

Version 3

Site Representative Electronic Signature:

Insert signature

PSCI Member Electronic Signature:

Insert signature

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 membe

Agree to share the completed Audit Report and Corrective Action Report with all current and future PS

Agree to share completed Audit Report and Corrective Action Report with only specific PSCI members
of members can be found at https://pscinitiative.org/members):

Electronic Signature:

Insert signature
Site comments:
 Description of Finding Corrective Actions
Please describe the finding (as done in the Details of actions to be taken to
PSCI Audit Report) follow up on the Finding
uiring attention. It is the responsibility of the audited party to establish, implement, and maintain effective systems and procedures that c
scussed during the audit.

tect human life, the health of employees or the environment; May result in loss of license to operate or serious damage to reputation; Re

ty, or the environment. Findings that may pose major regulatory non-compliances or illustrate systemic program gaps.
ty, the environment. Findings that may pose minor regulatory non-compliances.

been discussed with and understood by you (the site management)

Name:

Title:

Date:

Name:

Title:

Date:

he findings:

Name:

Title:

Date:
 Name:

Title:

Date:

he findings:

Name:

Title:

Date:

Name:

Title:

Date:

he findings:

be shared with PSCI member companies.

with all current and future PSCI members:

h only specific PSCI members (please list, the full list

Name:

Title:

Date:
 Completion Timescale Verification Method
Timescale (Immediate, 30, 60, Desktop / Follow-Up Visit
90,180,365 days)
maintain effective systems and procedures that comply with the regulatory requirements. Due to the size of the site only

se to operate or serious damage to reputation; Require immediate corrective action by the supplier; Need to be

ustrate systemic program gaps.

Guidance Note
At the end of the audit, the site management are asked to sign this
document (in cell C39-41) to document their agreement on the findings
list and the proposed corrective actions. This can be done by signing a
print out of the draft CAP.

To add an electronic signature, insert a suitable scanned image or photo

of it and fill in your details in the adjacent cells. We recommend that you
use Microsoft Paint to resize your photos. To do so please follow these
instructions:
1) To start Microsoft Paint, click 'Start', 'Programs', 'Accessories', then
'Paint'.
2) Open the image file you wish to edit.
3) Click the 'Home' Menu at the top and select "Resize”.
4) Choose a percentage figure to resize the image: to avoid distortion,
choose the same percentage for horizontal and vertical stretch. Click OK.
5) Once you have the desired size, click File > Save As (to prevent
overwriting the original image).
Save As jpeg (this provides compression to make the file smaller) and
insert this picture in the relevant box.

Version 2 is to be used to reflect updates or changes to the CAP. New

versions of the CAP report should be signed by the site management and
the PSCI member company.
Version 3 is to be used to reflect updates or changes to the CAP. New
versions of the CAP report should be signed by the site management and
the PSCI member company.

Please select from dropdown list

 Responsible Person Verification Evidence and Status
Note if management agree to the Comments Open/Closed or comment
Finding, and document name of Detail of corrective actions
responsible person taken
requirements. Due to the size of the site only

e action by the supplier; Need to be

e site management are asked to sign this

to document their agreement on the findings
ective actions. This can be done by signing a

ature, insert a suitable scanned image or photo

in the adjacent cells. We recommend that you
ze your photos. To do so please follow these

, click 'Start', 'Programs', 'Accessories', then

u wish to edit.
at the top and select "Resize”.
gure to resize the image: to avoid distortion,
age for horizontal and vertical stretch. Click OK.
ired size, click File > Save As (to prevent
age).
es compression to make the file smaller) and
levant box.

reflect updates or changes to the CAP. New

t should be signed by the site management and
ny.
 reflect updates or changes to the CAP. New
t should be signed by the site management and
ny.
Guidance Note

Please select from the dropdown list for 'Finding number',

'Finding Type', 'Completion Timescale', 'Verification Method' and
'Status' columns.