PART A : FOOD HYGIENE ASSESSMENT AS PER IS 2491

Process/Function Audited
CLAUSE No. & REQUIREMENT

CHECKLIST FOR HACCP

Details of compliance observed, Comments/
Remarks and Non-conformity, if any

4. PRIMARY PRODUCTION
- Environmental Hygiene
- Hygiene production
- Handling, Storage and Transport
5. ESTABLISHMENT, DESIGN & FACILITIES
5.1
Location
- Establishment
- Equipment
5.2

Premises and Rooms

- Design and Layout
- Internal structure and fittings
- Temporary/Mobile Premises and
Vending Machines

5.3

Equipment
- General
- Food Control and Monitoring Equipment
- Containers for Waste and Inedible
Substances

5.4

Facilities
- Water Supply
- Drainage and Waste Disposal
- Cleaning
- Personnel Hygiene Facilities and Toilets
- Temperature Control
- Ventilation
- Lighting
- Storage
6. CONTROL OF OPERATIONS
6.1 Food Hazards
6.2 Hygiene Control Systems
- Time and Temperature Control
- Microbiological Cross-Contamination
- Physical and Chemical Contamination
6.3 Incoming Material
6.4 Packaging
6.5 Water
- In contact with food
- As an Ingredient
- Ice and Steam

6.6 Management and Supervision

6.7 Documentation and Records
6.8 Recall Procedures
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Doc: MSC-F6.4-22 (HACCP)
Issue: 01
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Sign. of Auditor/
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Date: Jul 2007
Approved by: ADG

PART A : FOOD HYGIENE ASSESSMENT AS PER IS 2491

Process/Function Audited
CLAUSE No. & REQUIREMENTS

CHECKLIST FOR HACCP

Details of compliance observed, Comments/
Remarks and Nonconformity, if any

7. ESTABLISHMENT -MAINTENANCE AND SANITATION

7.1 Maintenance and Cleaning

- General
- Cleaning Procedures and Methods
7.2 Cleaning Programmes
7.3 Pest Control Systems
7.4 Waste Management
7.5 Monitoring Effectiveness
8. ESTABLISHMENT - PERSONNEL HYGIENE
8.1 Health Status
8.2 Personnel Cleanliness
8.3 Personnel Behavior
9. TRANSPORATION - CONVEYANCE & BULK CONTAINER
9.1 Design and Construction
9.2 Use and Maintenance
10 PRODUCT INFORMATION AND CONSUMER AWARENESS
10.1 Lot Identification
10.2 Product Information
10.3 Labelling
10.4 Consumer Education
11. TRAINING
11.1 Awareness and Responsibilities
11.2 Training Programmes
11.3 Instruction and Supervision
11.4 Refresher Training
12. ANY ADDITIONAL INFORMATION
- Any product specific hygiene codes
- Calibration Procedures
- Vendor Programmes
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Issue: 01

Date: Jul 2007

Approved by: ADG

PART B : AUDITING AS PER IS 15000

Process/Function Audited
REQUIREMENTS

CHECKLIST FOR HACCP

Details of compliance observed, Comments/
Remarks and Nonconformity, if any

SECTION I : AUDITING HACCP PRELIMINARY STEPS

Have all five preliminary steps been completed
Is the HACCP team identified
Is HACCP plan approval obtained and any plan revisions
identified
Is the food properly described including name, state of food prior
to consumption, preservation, method, packaging, distribution,
shelf life, labeling and special controls for distribution
Has a raw material and ingredients list been completed for each
Food
Is the intended use of the food identified
Does the flow diagram commence at the earliest possible point
and end at the last handling point of the product
Is a diagram of the plant layout included
Has the flow diagram been completed to include all steps even
optional steps
Has the flow diagram been verified by the HACCP team to
ensure that it is complete and accurate (evidence of this
required -signed record)
If there have been modifications to the food product or
process. Have the preliminary steps been included in the
HACCP revalidation
SECTION II : AUDITING COMPLIANCE TO HACCP PRINCIPLES
Principle 1:

Hazard Analysis

Has a biological, chemical and physical hazard assessment been

completed for all ingredients, raw materials, process and post
production steps
Have all hazards been considered for all raw ingredients and
materials and all process steps
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Issue: 01

Date: Jul 2007

Approved by: ADG

PART B : AUDITING AS PER IS 15000

CHECKLIST FOR HACCP

Process/Function Audited

Details of compliance observed, Comments/

Remarks and Nonconformity, if any

REQUIREMENTS
Principle 1:

Hazard Analysis (Contd.)

Are preventive measures/control measures identified for hazards

Are preventative measures carried out as described in HACCP
plan (evidence of records and observe what is done in practice)
Has a risk assessment been conducted to determine significant
hazards
Has the end product use of food been considered in the risk
assessment
Is the reference material used by the HACCP team to determine
hazards and risk/severity available so as to provide a rational
for the decision (i.e. transparent decisions)
Is the scope of the plan (i.e. food safety only or food safety and
quality applied consistently)
Have hazards that are outside the direct control of the plant
been considered in the hazards analysis (e.g. distribution)
Principle 2 Critical Control Points
Does each significant hazard have a CCP
Are CCP's properly implemented
Are there procedures/work instructions for each CCP
See Critical Control Point procedure and process checklist
Principle 3 Establish Critical Limits
Are critical limits assigned for each CCP
Have critical limits been validated (review objective evidence of
validation which may include documented factory trials and
research, references to regulatory and scientific information, etc.
Are critical limits implemented (review of monitoring records,
observe process)
Are critical limits appropriately described,
minimum values
Has data been presented
that
appropriateness of the critical limits?

i.e. maximum/

demonstrates

the

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PART B : AUDITING AS PER IS 15000

CHECKLIST FOR HACCP

Process/Function Audited

Details of compliance observed, Comments/

Remarks and Nonconformity, if any

REQUIREMENTS
Principle 4 Monitoring
Are monitoring records maintained in accordance with the CCP's
Monitoring procedure should describe the what, how, where,
when, who information
For every critical limit there must be a monitoring action that
includes the answers to the template
Is monitoring adequate and does it provide a high level
assurance that the process is under control
Principle 5. Establish Corrective Actions

of

Are corrective action records completed for all deviations from the
critical limit
Do corrective action records correlate to the relevant monitoring
records
Corrective action needs to flow a template.
The description should include the segregation, correction and
disposition actions with the name of the responsible person.
Are corrective action records reviewed, so as to assess the
HACCP plan for any trends.
Principle 6 Record keeping
When looking at records, you are looking for discrepancies that
indicate non-compliance with the HACCP plan. The following
are some common errors that occur when records are filled out
incorrectly:
- Data entered ahead of time. This can be detected by evenness of
the columns of data,(one number directly under another)
- Failure to recognize process deviations. .Check each monitoring
point against the critical limit
- Failure to correlate the time of day with the record. Look for
sequential time periods and the use of only even times, e.g.
8:30,9:30 instead of 8:32, 9:36.
- Look for the correlation with other records by time, batch or lot
number

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PART B : AUDITING AS PER IS 15000

Process/Function Audited
REQUIREMENTS
Principle 6 Record keeping (contd.)
- Check calibration records to see that calibration was performed using
the right methods and standards. Look for potential falsification, preentry of data and other errors.
- Check training records to see that training was carried out as required
in the procedures
- Are the records of all HACCP verification activities maintained
- Examine records in accordance with a sampling plan.
In most cases, you cannot possibly look at every HACCP record
generated. For example, if there is a three month lapse since last
verification visit, following sampling plan might be used.
Table 1 Record sampling plan for a three month cycle
Number of days within production within 3 months
Sample size of number of records to be reviewed
1-5 days
All days
6-10 days
5 days
11-20 days
6 days
21-90 days
7 days
- A sample of record must be taken randomly, i.e. consecutive days from
one month would not be considered random. One way to randomize
sample is to use a Table of Random Numbers
- For example, upon verification it is discovered that the product
under question was produced on 16 days of past three months. The 16
days have occurred as follows; 5 days in month 1, 5 days in month 2
and 6 days in month 3. According to Table 1, 6 days of production
HACCP records should be reviewed .
- Which days should be reviewed? If you want to use the table of
random numbers, then consecutively number each day of production, 1
through 16 . Select any point on the table of random numbers as the
start. Remember to move in one direction through the table from the
starting point. Move until you find a number 1-16. Continue to select
6 numbers (total) between 1 and 16. These six numbers will be the days
of production for record review.
- Make sure that at least one day per month is samples. In the example,
you must have at least only day between 1-5, one between 6-10 and one
between 11-16. If the first six random number do not represent all
intervals, then continue selection until all intervals are represented.
- If you do not want to use Table of Random Numbers, then select days
at random. You can also consider when errors are most likely to be made.
Monday mornings, holidays, end of shift, end of week, weekends,
nightshift & production change over.

Sign. of Auditor/
Expert
Date: Jul 2007
Approved by: ADG

CHECKLIST FOR HACCP

Details of compliance observed, Comments/
Remarks and Nonconformity, if any

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PART B : AUDITING AS PER IS 15000

Process/Function Audited
REQUIREMENTS
Principle 6 Record keeping (contd.)
- Remember that the objective is to collect objective evidence.
Suspecting improper record completion is a long way from having
objective evidence. By familiarizing yourself with the major problems in
record keeping an developing a "sixth" sense for an improper record,
you improve your skills as a verifier. However, objective evidence must
then be collected. It may be necessary to go back to a particular CCP and
observe its operation. Record you own monitoring data. Also, check the
operating instructions. Sometimes the instructions are not clear or the
operator has misunderstood them.
- The record must include the date, time, product identification, (batch
number, lot number, line number, container size, etc.), process step
identification, critical limit and signature (one of the record keeper and
one of record verifier)
- Corrective action records must be able to reconciled to the monitoring
records and include a description of the problems, the segregation, the
correction and the disposition.
- Correction action records also should include the date, time and two
signatures. Corrective action records should be filed in separate file for
easy access.

Sign. of Auditor/
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CHECKLIST FOR HACCP

Details of compliance observed, Comments/
Remarks and Nonconformity, if any

Principle 7. Verification
Verification activities should be identified with a separate frequency (i.e.
daily, weekly, monthly) and recorded on verification inspection schedule
Review of the HACCP plan and its implementation
Validation of critical limits
Presence of correctness of CCP monitoring
Presence and correctness of CCP monitoring
Sample analysis to verify CCP is under control
Verifying the monitoring and corrective action procedures.
Verification activities demonstrate that HACCP programme is effective
Verification of prerequisite and supporting programs is also required.
Included in these activities could be;
- equipment calibration,
- review of purchase specifications,
- ingredient sampling,
- end product sampling
- environmental sampling
- stock rotation checks
- product challenge tests
- confirm cleaner and sanitizer concentrations
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Date: Jul 2007
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