PART A : FOOD HYGIENE ASSESSMENT AS PER IS 2491 CHECKLIST FOR HACCP

Process/Function Audited
Details of compliance observed, Comments/
CLAUSE No. & REQUIREMENT 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 Date: Jul 2007
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PART A : FOOD HYGIENE ASSESSMENT AS PER IS 2491 CHECKLIST FOR HACCP
Process/Function Audited
Details of compliance observed, Comments/
CLAUSE No. & REQUIREMENTS Remarks and Non-
conformity, 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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PART B : AUDITING AS PER IS 15000 CHECKLIST FOR HACCP

Process/Function Audited
Details of compliance observed, Comments/
REQUIREMENTS Remarks and Non-
conformity, 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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PART B : AUDITING AS PER IS 15000 CHECKLIST FOR HACCP

Process/Function Audited
Details of compliance observed, Comments/
REQUIREMENTS Remarks and Non-
conformity, if any
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, i.e. maximum/

minimum values

Has data been presented that demonstrates the

appropriateness of the critical limits?
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PART B : AUDITING AS PER IS 15000 CHECKLIST FOR HACCP

Process/Function Audited
Details of compliance observed, Comments/
REQUIREMENTS Remarks and Non-
conformity, if any
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 of

assurance that the process is under control
Principle 5. Establish Corrective Actions

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 CHECKLIST FOR HACCP

Process/Function Audited
Details of compliance observed, Comments/
REQUIREMENTS Remarks and Non-
conformity, if any
Principle 6 Record keeping (contd.)

- Check calibration records to see that calibration was performed using

the right methods and standards. Look for potential falsification, pre-
entry 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.
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PART B : AUDITING AS PER IS 15000 CHECKLIST FOR HACCP

Process/Function Audited
Details of compliance observed, Comments/
REQUIREMENTS Remarks and Non-
conformity, if any
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.
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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