Validation, Verification and Reassessment of The HACCP

Verification and Reassessment
of the HACCP Plan

EIAO Training
1 1
Objectives
You should be able to:
 Define verification and reassessment
 Describe how to verify the verification
requirement
 Describe how to verify the reassessment
requirement
2 2
Terminology
 The term “Verification” can be confusing
because it is used for different activities
depending upon the context.
3 3
Terminology
 Verification (Usage 1)
 One of the seven HACCP Principles
 Broad meaning of the term

 Activities other than monitoring that determine the HACCP
system is functioning as intended
 This encompasses:
 Initial Validation
 Ongoing Verification
 Reassessment
4 4
Terminology
 Ongoing Verification (Usage 2)
 More narrow term
 Specific activities that occur on an ongoing basis to

ensure that the HACCP plan is being followed
 Examples
 Sampling
 Calibration
 Direct observation of monitoring
 Records review
5 5
Terminology
 Verification by USDA (Usage 3)
 Procedures FSIS employees use to determine if

regulatory requirements are met
6 6
Requirements - 9 CFR 417.4
 Validation: Demonstrates that the HACCP
system can and does work as intended under
plant conditions.
 On-going verification: Demonstrates that the

establishment continues to produce safe,
unadulterated products.
 Reassessment: Response to situations that may

affect the effectiveness of the HACCP system or
the establishment’s ability to carry it out.
7 7
Validation vs. Verification
 Validation: demonstrates the HACCP
system as designed can adequately control
hazards to produce a safe, unadulterated
product.
 Verification: ongoing activities to

demonstrate conformance to the HACCP
system
8 8
Ongoing Verification
Requirements
9 9
Regulations
 9CFR 417.2(c)(7)
 9CFR 417.4(a)(2)(i)(ii)(iii)
10 10
Gather Information
 Does the HACCP plan contain:
 Procedures and frequencies for calibration of

process-monitoring instruments?
 Procedures and frequencies for direct

observation of monitoring activities and
corrective actions?
11 11
Gather Information
 Does the HACCP plan list:
 Procedures and frequencies for the review of

records generated and maintained in
accordance with 9 CFR 417.5(a)(3)?
 Product sampling as a verification activity?
12 12
Gather Information
 Are process-monitoring instrument calibration
activities conducted as per the HACCP plan?
 Are direct observation verification activities

conducted as per the HACCP plan?
 Are records generated in accordance with 9

CFR 417.5(a)(3) being reviewed by the
establishment?
13 13
Reviewing HACCP Plan
 Are procedures and frequencies for all 3
activities included?
 Calibration
 Direct observation
 Records review
14 14
Sample HACCP Plan
CCP Name Step Verification Question
Activity The Support
CCP 1 Cook Calibration DO

RR
CCP 2 Chill Direct Calibration

Observation RR
CCP 3 MD Record Calibration

Packaging Review DO
15 15
 Calibrating monitoring equipment, direct

observations, and records reviews do not
have to all be addressed at each CCP, but all
3 should be addressed in the plan
16 16
 Some HACCP plans might not contain all 3
activities
 Example - CCP monitored without process

monitoring equipment
 Example - Continuous monitoring equipment
17 17
Reviewing Verification Records
 Are verification procedures performed at
the frequency described in HACCP plan?
18 18
Product sampling
 If product sampling is included in
verification activities
 Observe employee take sample
 Review results
19 19
Knowledge Check
 What are the three types of on going
verification activities listed in the
regulations?
20 20
Reassessment Requirement
22 22
Reassessment of the HACCP Plan
 Annual Requirement
 Process Change
 417.4(a)(3)(i)(ii)
 Establishment Training
 417.7
23 23
Reassessment of the HACCP Plan
 Annual requirement
 Reassess annually
 HACCP plan signed and dated
 417.2(d)(iii)
 Reassessment must be documented under
417.4(a)(3)(ii)
 If changes made must document the reason
 If no changes on annual reassessment no need to
document
24 24
Training Requirement
 417.7
 HACCP trained person involved in development
and reassessments
 No documentation required to verify
HACCP
25 25
Reassessment Due to Process Changes
 Reassessment is required for changes that
could alter the hazard analysis
 If plan no longer meets regulatory
requirements modify immediately
 Required to document reassessment under
417.4(a)(3)(ii) and document the reason for
changing or for not changing
26 26
Possible Process Changes
 raw materials or source  packaging
of raw materials
 distribution systems
 product formulation
 slaughter or processing  intended use or

methods or systems consumers
 production volume  personnel
27
27 27
Gather Information
 Did the establishment perform the annual
reassessment of its plan or plans at some
point during the previous calendar year?
 Did the establishment consider any

significant developments that have
occurred in the plant in its analysis?
28 28
Gather Information
 Has a change occurred that could affect the
hazard analysis or HACCP plan?
 Did the establishment reassess?
 If the reassessment revealed that the

HACCP plan no longer met regulatory
requirements, was the HACCP plan modified
immediately?
29 29
Gather Information
 Did the establishment sign and date the
plan during the previous calendar year and
upon any modification to the plan?
 Has the individual who reassessed the

HACCP plan or who modified the plan,
completed training in the 7 HACCP
principles including a segment on HACCP
plan development and review of records?
30 30
Assess Information
 To obtain answers, review
 Reassessment records
 HACCP plan
31 31
QUESTIONS?
32 32

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Verification and Reassessment

of the HACCP Plan

 One of the seven HACCP Principles

 Broad meaning of the term

 More narrow term

 Specific activities that occur on an ongoing basis to

 Procedures FSIS employees use to determine if

 On-going verification: Demonstrates that the

 Reassessment: Response to situations that may

 Verification: ongoing activities to

 Procedures and frequencies for calibration of

 Procedures and frequencies for direct

 Procedures and frequencies for the review of

 Product sampling as a verification activity?

 Are direct observation verification activities

 Are records generated in accordance with 9

CCP 1 Cook Calibration DO

CCP 2 Chill Direct Calibration

CCP 3 MD Record Calibration

 Calibrating monitoring equipment, direct

 Example - CCP monitored without process

 Example - Continuous monitoring equipment

 Observe employee take sample

 slaughter or processing  intended use or

 Did the establishment consider any

 Did the establishment reassess?

 If the reassessment revealed that the

 Has the individual who reassessed the

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