Validation Plan Template

Documentation template & evaluation instrument

Document ID: IIN311-G Effective Date: 26-AUG-2020 Rev : 3
Page: 1 of 11

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Validation Plan (VP)
Pre & Post Approval document

Validation Plan ETHILON Surgical Suture Packaging Process

Project Name Validation Plan

VP number VP-04-FEB-2022

Please delete all not used blue text. Change blue to black if needed.

Approval block:

Pre-approved by: Date

Fernando Beltre 01-Mar-2022

Leandro Sanz 01-Mar-2022

Carol Vargas 01-Mar-2022

Junior Jimenez 01-Mar-2022

Add/remove rows to include/remove additional signatures from VRB Members.

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1 General VP Information

☐ Initial validation ☐ Re-validation

1.1. Primary VP Type:
☒ Change to an existing validation ☐ Decommissioning

☐ Facility Test Method

1.2. VP Subject: (select as
☐ Utility ☒ Process
many as required)
☒ Equipment
1.3. Product family(s)/
Ethicon Non-Absorbable Monofilament Suture
subfamily(s):

SN-5667
SN-5698G
1.4. Applicable
SN-5669
products/models:
SN-5663
SN-5667G

Identifier No. Model Description

RK-MW01 Mono Winder Cutting sutures machine
DE-AM5A 5-A Suture attaching
machine
1.5. Machine/Instrument AW-0001 N/A Automatic Winder
identifier numbers machine
and description ST-T001 N/A Tensile testing machine
ES-SS01 AN 306 Sterilization machine
VA-V001 VP540 Packaging machine
ZT-4001 400 Printer machine

Add/delete rows as required

1.6. Area where the

change will be The validation plan will be executed on line 04, of J&J Dominican Republic.
performed:

1.7. ECR number: ECR-000342

Identifier No. Related Previous Documentation

number
RK-MW01 VP-00-OCT-2018.
1.8. Previous VP /
DE-AM5A VP-00-OCT-2018.
Validation Protocol or
legacy validation AW-0001 VP-00-OCT-2018.
documentation used ST-T001 VP-00-OCT-2018.
as support:
ES-SS01 VP-00-OCT-2018.
ZT-4001 VP-00-OCT-2018.
Add/delete rows as required

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2 Change Information

The VACMASTER VP540 machine is going to be implemented t To improve

2.1 Change Description the packaging process .
the VACMASTER VP540 machine is to be implemented
. This will allow to increase the packing volume from medium to
high volume. This machine will be be installed on the manufacturing line 4.

The reason for implementing these changes is to increase the productivity of

2.2 Reason for change the packaging process in the factory located in PIISA.This will help improve
delivery times, packaging quality

The changes are necessary because efficiency levels need to be improved in

the packaging process at the Johnson and Jhonsons Johnson’s production
plant.

It has to be validated to ensure that the company is complying with the

2.3 Justification for change regulations required by the entities.

The changes are intended to maximize the use of space and production
efficiency in the product line.

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3 Change impact assessment and validation scope determination

Before filling the table below, complete the questions of the Validation Plan impact assessment form IIN311-R (http://bit.ly/2KCR6

Impact assessment is the process by which the impact of equipment on the product quality is evaluated, and
the critical components of equipment/ system are identified. The amount of qualification effort and deliverables
needed as part of this validation plan are determined based on an impact assessment. The impact
assessment is based on a three level scale of the validation plan, the three level scale is defined on the
following table:

Applicable level of Impact of the change and amount of qualification/validation effort required

Impact Applicable impact

Description
Level category
With the change, the system under scope will affect critical quality
High attribute(s) of the product and/or will be affecting the product’s ☒ Direct Impact
quality and/or safety
The change will be made to a system that supports a direct impact
system. To be indirect impact, the system it is connected to must
Medium ☐ Indirect Impact
be able to detect and prevent quality-threatening effects of the
indirect impact system’s operation.
☐ Minimum (or non)
Low Has no influence upon product quality attributes.
Impact

The table below details all the deliverables that will be generated as part of this change depending on the
impact. Some deliverables may be considered as not applicable. Appropriate rationale is provided next to
each of them.

Legend:
✔ = Recommended to be performed. It may be avoided based on appropriate rationale.
VRB = indicates that the deliverable may be required as specified by the Validation Review
Board
✕ = Not recommended. It may be performed as per VRB decision.

Validation lifecycle System Impact Level

Deliverable
Phase High Medium Low
User Requirement(s) Specification
VRB ✕ ✕
(URS)
Functional Requirements Specifications
VRB ✕ ✕
(FRS)
Design Phase
Design Specifications
VRB ✕ ✕
(DS)
Risk Assessment
✔ ✕ ✕
(RA)

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Design Qualification
VRB ✕ ✕
(DQ)
Factory/Site Acceptance Test
VRB ✕ ✕
(FAT) & (SAT)
Installation Qualification
✔ VRB ✕
(IQ)
Process Characterization Study VRB VRB ✕
(CS)
Operational Qualification VRB ✕
✔
Qualification (OQ)
performance Phase
Performance Qualification
✔ VRB ✕
(PQ)

Training ✔ ✔ ✕

Calibration ✔ ✔ ✔

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4 Validation Deliverables:

Based on the impact assessment of section 3, indicate on following table which validation-related documents will
be completed to successfully conclude each validation phase. If considered as not applicable, justification for no-
execution can be found on the right:
Check if
Deliverable Justification if not applicable
applicable

Risk Assessment
☒ N/A
(RA)

Installation
Qualification ☒ N/A
(IQ)

Test Method
Validation ☒ N/A
(TMV)

Process
Characterization
Study ☒ N/A
(CS)

Operational
Qualification ☒ N/A
(OQ)

Performance
Qualification ☒ N/A
(PQ)

Other validation-
related ☐ Other validation-related documentation is not required
documentation

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5 Deliverables Control
Following table is a list of validation related deliverables that will be generated. The following table is
intended to be as follow up tool of all the requirements.

Protocol No. Protocol Title Protocol Completed by Verified by

(Signature / Date) (Signature / Date)

IQ- 01 04-Mar- Installation Qualification protocol

2022 for VacMaster VP540 - VA-V001

OQ- 04 01-Mar- Operational Qualification protocol

2022 for VacMaster VP540 - VA-V001

Performance Qualification
PQ- 04 01-Mar-
protocol for VacMaster VP540 -
2022
VA-V001

RA- 04 01-Mar- Risk Assessment protocol for

2022 VacMaster VP540 - VA-V001

TMV- 04 01-Mar- Test Method Validation protocol

2022 for VacMaster VP540 - VA-V001

Characterization Study protocol

C
for VacMaster VP540 - VA-V001

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6 Additional Deliverables
Following table is a list of other related deliverables that will be generated as part of this VP. The
following table is intended to be as follow up tool of all the requirements.

Type of Completed by Verified by

Action description
Action (Signature / Date) (Signature / Date)

N/ An Other additional
related deliverables
A are not required.

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7 VP Dates

7.1 Proposed Start Date 07-Mar-2022

7.2 Proposed End date 11-Abril-2022

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IIN311-G Re 3 Validation Plan Template Page: 11 of
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1. Evaluation Results
Completion Accuracy Comprehension Organization Conventions Final score
(Average)
5 5 4 3 4 4.2=8.4

1. Evaluation Rubric

Each case study / reading will be 5 valuated in points each. The 5-point score will be an average of the 5
different categories shown below:

Score Completion Accuracy Comprehension Organization Conventions

5 The answer is All information provided Content demonstrates a Content is well- No major grammatical
complete. is accurate. deep understanding of, organized and easy to or spelling errors. No
and engagement with, read. Points follow a more than two minor
the text(s). logical progression. errors.
4 The answer is missing All information provided Content demonstrates Content is well- No major grammatical
slight details is accurate. understanding of, and organized and easy to or spelling errors. No
engagement with, the read. Points follow a more than five minor
text(s), logical progression. errors.
3 The answer is missing Most information Content demonstrates Content is organized Some major and minor
multiple details. provided is accurate. basic understanding of and easy to read. errors that don’t
the text(s). Points follow a mostly necessarily impair
logical progression. communication.
2 Content suggests lack Some information Content demonstrates Content may be Major and minor errors
of preparation or provided is accurate. less than basic unorganized and significantly weaken
comprehension. understanding of the difficult to read. Points quality of
text(s). do not follow a solidly communication,
logical progression. although still
comprehensible.
1 Content only marginally A small amount of the Content demonstrates a Content is unorganized, Communication
related to the information is accurate. lack of understanding of illogical, and difficult to seriously impaired by
question/prompt. the text(s). read. multitude of
spelling/grammatical
errors.
0 Content fails to meet None of the information Content demonstrates a Content is very poorly Multitude of major and
the basic requirements provided is accurate. complete lack of organized, illogical, and minor errors make
of the task. understanding of the difficult to read. answer
text(s). incomprehensible.

End of the document

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