Doc. Title: Checklist for Validation of Control Measures Doc. No.

FSSC/IAC/FM12
Prepared By Reviewed By Approved by
Revision No. 00
AM - JA FSTL GM

Compliance
Sr. # Questions
Yes No
1 Are all significant hazards clearly addressed & properly defined?

2 Are all acceptable levels accurate and authentic?

3 Is methodology used for meeting significant levels are accurate?

4 Is design of control increase appropriate to the identified hazards?

5 Does the design of control measure fulfill intended purpose?

6 Is control measure effective to control identified hazards?

7 Is monitoring frequency of control measure adequate?

Is relevant activity clearly defined, undertaken to confirm that level of
8 hazards in end product is within acceptable levels? (Eg: Process
verification data, independent lab testing, In-house FG testing)
Is sufficient data available to confirm that level of hazards in end
9
product is within acceptable levels?
If requirements of 4,5,6,9 cannot be confirmed, there is a need to
10
modify or reassess the control measure?
11 Tick where modification in control measures in needed:

a) Process Parameters

b) Rigorousness

c) Raw material receiving

d) Processing Technology

e) End product characteristics

f) Method of Distribution

g) Storage Conditions

h) Intended use of end product

 Doc. Title: Checklist for Validation of Control Measures Doc. No.
FSSC/IAC/FM12
Prepared By Reviewed By Approved by
Revision No. 00
AM - JA FSTL GM

Summary of Result of Validation Activity

Sign (FSTL) ____________________ Date ____________________

Decision in case results of validation of CM are not satisfactory

Proposed date for revalidation __________________________

Sign (FSTL) ____________________ Date __________________________

Comments / Remarks

Sign (FSTL) ____________________ Date __________________________