Validation Master Planqms.ccholdingsltd.com/P3026F(1) Validation Master Plan... · 2020. 7. 8. · Document No. XXXX/NNNN Version: A Page 2 of 14 Title; P3026F(1) Validation Master

Document No. XXXX/NNNN

Version: A Page 1 of 14

Title;

P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed

Validation Master Plan

For

Report No;

Author;

Report Approval Production Manager Print Name

Signature Date

Engineering Manager Print Name

Signature Date

Quality Manager Print Name

Signature Date



Title;


1 Revision History

Changed By Revision Date Reason for Change

Osman Edoo 01 26-Jul-2017 New Document

2 Introduction

The Purpose of this validation master plan is to define the steps that will be taken to validate device

xxxxx.

This validation will be conducted in accordance with ISO 13485 and where applicable 21 CFR Part 11. In

addition, this validation will be completed in line with Clement Clarke International procedures P3026 –

Validation Lifecycle, P0042 – Product Design, Layout and Process Control, P0758- New Product

Development, P3101 - Documentation Standards, P0765 – Application of Risk Management to Medical

Devices and where applicable, P0005 Computer Software Validation

3 Scope

The scope of this validation masterplan is specifically for the:

➢ Tooling /moulding validation

➢ Assembly validation

➢ Measurement system validation

➢ Packaging validation

➢ Brought in components



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The following will be out of scope for this validation:

➢ Design validation – Covered under design validation master plan XXXXX

4 Definitions

URS – User Requirement Specification

DQ – Design qualification

IQ – Installation Qualification

OQ – Operational Qualification

PQ – Process Qualification

5 Internal and External Document References

ISO 13485 - Medical devices - Quality management systems

21 CFR Part 11 - Computer systems validation

P3026 – Validation Lifecycle

P0042 – Product Design

Layout and Process Control

P0758- New Product Development

P3101 - Documentation Standards

P0765 – Application of Risk Management to Medical Devices

P0005 - Computer Software Validation – where relevant & applicable

P0042 – Engineering Change Control Process



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6 Responsibilities

Validation Activity Ownership (Participants) Lead Person

Validation Master Plan CCI QA/Product Engineering

Tooling/mould validation CCI

QA/Product Engineering

Assembly validation CCI


Measurement System Validation CCI

QA/RA Engineer

Packaging validation CCI


Risk Management CCI

QA/RA Engineer/ Maetrics Senior Associate



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7 Device

Insert Image

Device Name

Device XXXX in made up of:

Component Name/Type

Component Reference

Material Reference Number

Material Manufacturer Masterbatch Reference Number

Masterbatch % Manufacturer



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8 Validation Master Plan

The Validation of Device XXXX will be conducted in the following manner:

Figure One: Moulding/Tooling validation flow path



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Figure Two: Assembly validation flow path



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Figure Three: Measurement system validation flow path



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Figure Four: Brought in components validation flow path



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Figure Five: Packaging system validation flow path

8.1 Key Notes

➢ The validation / acceptance criteria will be defined by the above mentioned input documents for

each validation process.

➢ Any deviation from the validation plan and subsequent validation protocol will be documented

within the protocol and a risk assessment undertaken to ensure due diligence

➢ All Deviations will be reported in the final validation summary report

➢ Any deviation from P3026 from outset will be reported in this validation master plan (Appendix

One)

Document No. XXXX/NNNN Version: A Page 11 of 14

Title;

Print date:15 December 2017, 11:09:00 – Uncontrolled if Printed P3026F(1) Validation Master Plan iss 1 CCI.docx

9 Appendix One – Risk Assessment of deviation from validation masterplan

Risk management to be applied as per P0765.

Figure One: Risk scoring Matrix to be applied to deviations from the validation master plan

Risk Scoring Matrix

Severity of Harm

Negligible Minor Serious Critical Catastrophic

1 2 3 4 5

Pro

bab

ility

of

Occ

urr

ence

of

Har

m

5 L M H H H

4 L M M H H

3 L L M M H

2 L L L M M

1 L L L L L


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Table One: Risk assessment

Deviation Risk to validation Occurrence Severity

Overall Score Existing Controls

Action required

Revised Occurrence

Revised Severity

Overall Revised Score

e.g; Engineering - Stabilisation Time

Stabilisation time not determined

5 1 6 1) Moulding currently running in production with a stabilisation time of 15mins 2) Data from Cap study demonstrates acceptable CpK

None 5 1 6


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Deviation Risk Assessment Approval Production Manager Print Name

Signature Date

Engineering Manager Print Name

Signature Date

Quality Manager Print Name

Signature Date


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Documents

Validation Master Planqms.ccholdingsltd.com/P3026F(1) Validation Master Plan... · 2020. 7. 8. · Document No. XXXX/NNNN Version: A Page 2 of 14 Title; P3026F(1) Validation Master