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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
Document No. XXXX/NNNN
Version: A Page 2 of 14
Title;
P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed
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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Title;
P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed
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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Title;
P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed
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
QA/Product Engineering
Measurement System Validation CCI
QA/RA Engineer
Packaging validation CCI
QA/Product Engineering
Risk Management CCI
QA/RA Engineer/ Maetrics Senior Associate
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Title;
P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed
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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Title;
P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed
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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Version: A Page 7 of 14
Title;
P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed
Figure Two: Assembly validation flow path
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Title;
P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed
Figure Three: Measurement system validation flow path
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Title;
P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed
Figure Four: Brought in components validation flow path
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Title;
P3026F(1) Validation Master Plan, Issue 1, 31 Oct 2017 – Uncontrolled if Printed
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)
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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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Title;
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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
Document No. XXXX/NNNN Version: A Page 14 of 14
Title;
Print date:15 December 2017, 11:09:00 – Uncontrolled if Printed P3026F(1) Validation Master Plan iss 1 CCI.docx