ISO 22000:2005 Checklist and Audit Trace Record

Client Job No. Auditor Date

This Checklist is prepared according to the requirements of ISO 22000:2005. Applicable vertical/horizontal regulations shall be used as integrated part of the assessment.

General* Document Review Follow-up

* Use of Logo/ Certificate

* Organization Size (info including no. of employee etc) Verification. Is audit time sufficient?

* Scope Wording Verification

1.Management Responsibility

1.1Is there evidence to show management commitment to Food Safety system application?Are these shown in the related objectives

Are objectives measurable?

1.2Does the organisation have a food safety policy?

1.3Has a HACCP plan been developed?

Does the plan cover all end products?

1.4Has a multidisciplinary Food Safety team been formed?

1.5Have the organisation appointed a Food Safety team leader and defined the responsibilities and authorities

1.6Does the organisation define the responsibility and authority of the Food safety team.

1.7Is the knowledge of the food safety team suitable and appropriate(check training, qualifications, experience, etc)

1.8

1.9

1.10How is internal and external communication controlled and who has responsibility? Is the communication effective?

Do the company have emergency preparedness and response procedures in place? Have they been verified?

Is a Management Review activity carried out as required?

Is it effective?

2.Resource Management.

11.1How are competencies defined for people who can have an effect on product safety?

11.2Does the organisation have training plans?

11.3How many personnel have been trained in HACCP principles and the relevant legislation and regulations?

11.4How many personnel have been trained to perform internal audits?

11.5How does the organization train personnel on sanitation control?

11.6How does the organisation verify the effectiveness of training?

2.PRODUCT SPECIFICATION

2.1*Has the product or product range been fully described

2.2*Does the specification include safety information (such as PH, aw, etc.)?

2.3Does the specification include details of raw material and ingredients?

2.4Does the specification include the type of packaging

2.5Does the specification include the storage conditions

2.6Does the specification include labelling instruction

2.7Does the specification include the method of distribution (in

detail)?

2.8Does the specification include shelf life and storage conditions?

2.9Does the specification include the intended use?

2.10Does the specification include the appropriate consumer? (e.g. allergenic, elderly, infants or children, institutional feeding, immune compromised, etc )

2.11Does the specification include the specific methods of use?

3PROCESS FLOW DIAGRAM

3.1Is the process flow diagram comprehensive?

3.2Are all raw materials, ingredients, packaging materials and process/storage activities included in the process flow

diagram?

3.3Have changes been made since the process flow diagram was established

3.4How does the HACCP team get notified of changes to the process or product parameters?

3.5How were the changes recorded and approved?

3.6Were any changes discussed with HACCP team before implementation

3.7Has the process flow diagram been verified on-site for the compliance with the actual operation?

4.HAZARDS ANALYSIS AND PREVENTIVE MEASURES

4.1How was the hazard analysis conducted?

4.2Have all hazards been evaluated qualitatively and/or quantitatively?

4.3Have all raw materials been included

4.4Have all process steps been considered?

4.5Have the hazards been specifically identified or just in general?

4.6How did the team assess the likelihood of occurrence

4.7What information sources were utilised?

4.8Have appropriate preventive measures been set up for each hazard?

4.9Do the measures prevent or reduce to an acceptable level the hazards and how were the measures were validated?

4.10Are all preventive measures in place at the plant level?

5.CRITICAL CONTROL POINTS CCPS

5.1How were the CCPs identified?

5.1.1By the use of CCP decision tree?

5.1.2Have all necessary CCPs been identified?

6.CRITICAL LIMITS

6.1*Have critical limits been established for each CCP?

6.1.1How were the critical limits established?

Is there evidence? (national/ international standard, requirements of relevant legislation, experimental data, literature references etc) ?

6.1.2*What validation exists to confirm that the critical limits can prevent possible occurrence of hazards?

6.2How does the organisation differentiate the critical limits from operational limits?

6.3Are the critical limits implemented at plant level

7.MONITORING PROCEDURES

7.1Have monitoring procedures been established for all CCP's established?

7.2Is there any evidence that procedures are being followed consistently?

7.3What is the status of monitoring equipment?

7.4Are the sampling plans statistically valid?

7.5Have the organisation a clear system for product identification of product to ensure traceability if deviation occurs?

7.6Have the organisation taken any actions when deviation occurred?

7.7Are monitoring personnel trained and qualified?

7.8Have monitoring results been recorded?

8.CORRECTIVE ACTIONS

8.1Are the corrective action procedures in place?

8.2What evidence is there to demonstrate that effective corrective actions are taken in the event of a CCP deviation?

8.3Has the responsibility and authority for corrective action been defined?

8.4How non-conforming product controlled and recorded?

8.5How does the organisation dispose of any affected products?

8.6Has corrective action been recorded and how is the effectiveness verified?

8.7Do these corrective actions consider modifying the process or HACCP plan, if the critical limit is violated consistently

9.VERIFICATION PROCEDURES

9.1Have verification procedures been established?

9.2Have the responsibilities, authorities, methods, frequency and type of verification been defined in the procedures?

9.3Are the methods and frequency sufficient to ensure that the system is working correctly, effectively and complies with relevant regulations

9.4How did the organisation conduct the initial validation of HACCP plan

9.5Do the procedures include review of records?

9.6Is there a regular review of CCP failure and product dispositions?

9.7Do the procedures include calibration of monitoring and measuring equipment?

9.8Have personnel responsible for verification been trained?

9.9Do the procedures include evaluation of customer and consumer complaints?

9.10Is there a regular review of results of sanitation control procedures?

9.11How is the data from verification being used to improve the HACCP system?

10.DOCUMENTATION AND RECORD KEEPING

10.1What procedure does the organisation follow to manage system documents ?

10.2Does the documentation cover all of the HACCP system operation?

10.3Have documents been properly approved by authorised personnel before issue,?

10.4How is the documentation controlled

10.5Has the organization obtained related codes, standards, legislation and regulation to the food product?

10.6How does the organisation control document changes? Are all documents current?

10.7Are the records accessible?

10.8Are the HACCP records clearly identified?

10.9Has the documentation and record control system been set up in consideration of the size and nature of the organization?

10.10Are the HACCP records retained in the proper conditions to prevent damage, deterioration or loss?

10.11How long does the organization retain the records?

11.TRAINING

11.1Have they developed a training procedure for identifying training needs and training personnel?

11.2Does the organisation have training plans?

11.3How many personnel have been trained in HACCP principles and the relevant legislation and regulations?

11.4How many personnel have been trained to perform internal audits?

11.5How does the organization train personnel on sanitation control?

11.6How does the organisation verify the effectiveness of training?

12.RECALL

12.1Does the organisation have a procedure to manage product recall?

12.2In what circumstance do the products need to be recalled?

12.3Have the responsibility and authority been defined?

12.4Has there been a full or partial product recall?

12.5How many products were concerned?

12.6What was the reason?

12.7How did the organisation handle these products?

12.8How did the organisation ensure all affected product was identified and recalled?

13.COMPLAINT

13.1Does the organisation have a procedure to deal with all consumer and customer complaints?

13.2Have the responsibility and authority been defined?

13.3Did the complaints concern product safety

13.4What actions have the organisation taken?

13.5Have these complaints been documented?

13.6Have these complaints been utilized for verification of the system?

14.SANITATION CONTROL PROCEDURES

14.1Does the organisation have documented hygiene control procedures?

14.2Do the procedures cover all aspects of sanitation and hygiene?

14.3Have sanitation procedures been verified for effectiveness

14.4What actions did the organisation take when the procedures were violated?

14.1Safety of Water

14.1.1Has the organisation tested water quality, how often and by whom?

14.1.2Does the organisation use mains, well or bore hole waterWhat is the status of the environment?

14.1.3Has the water been treated? (e.g. chlorination, softening)

14.1.4Has the treatment been monitored?

14.1.5Is there any contamination possibility? (e.g. cross-contamination between potable water and non-potable water etc.)

14.1.6Have records are kept of water treatment and quality

14.2Condition and Cleanliness of Food Contact Surfaces

14.2.1Does the condition of food contact surfaces meet the requirement of hygiene? (Equipment, facilities, clothing and gloves of employees etc.)

14.2.2Does the organisation have cleaning plans?

14.2.3Are the plans adequate

14.2.4Are there adequate cleaning facilities in place and are the facilities in good condition?

14.2.5Have the results of cleaning been monitored and verified for effectiveness?

(e.g. microbiological analysis)

14.2.6Have the employees been trained for personal hygiene?

14.3Prevention of Cross-contamination

14.3.1Is the layout, flow of material and personnel sufficient to prevent cross contamination?

14.3.2Have the equipment and facilities in different risk areas been properly separated?

14.3.3How does the organisation handle contaminated products

14.3.4Is there any other cross-contamination that is likely to occur? (e.g. truck, cart, etc.)

14.4Maintenance of Hand Washing, Hand Sanitising and Toilet Facilities

14.4.1How does the organisation maintain these facilities?

14.4.2Does the organisation have adequate hand washing and sanitising facilities in production areas? (Entrances and main production areas)

14.4.3Does the organisation have adequate toilet facilities and is the condition acceptable

14.5Protection of Food, Food Packaging Material, and Food Contact Surfaces from Adulteration

14.5.1Are packaging materials stored in good condition?

14.5.2Are the products and packaging materials being protected from contamination?

14.5.3Is condensate present

14.5.4Are lubricants and cleaning chemicals properly controlled?

14.5.5Are lights adequately protected? (Glass)

14.5.6Is the condition of the environment around the production area/s suitable

14.6Proper Labelling, Storage and Use of Toxic Compounds

14.6.1Has the organisation appointed personnel responsible for toxic compounds? (e.g. cleaning and pest control chemicals)

14.6.2Are these toxic compounds stored separate to raw materials, ingredients and packaging materials?

14.6.3Are these toxic compounds clearly labelled for identification

14.6.4Are there handling/usage instructions available?

14.6.5Does the organisation keep records of the use?

14.6.6Have the personnel been trained in the safe handling and use of such materials

14.7Control of Employee Health Conditions

14.7.1Are there any procedures to control employee health and sanitation condition?

14.7.2Are the procedures being implemented?

14.7.3Have the employees undergone periodic health examination or screening(Health certificates etc.)

14.7.4How does the organisation manage return to work following illness

14.8Exclusion of Pests

14.8.1Does the organisation have a pest control plan/system?

14.8.2Are rodent, bird and insect prevention facilities suitable and appropriate?

14.8.3Are doors, windows and other facilities in good condition

14.8.4How does the organisation ensure all pests are being controlled effectively?

14.8.5Have these controls been documented?

14.9Construction and layout

14.9.1Are walls and floors in good condition?

14.9.2Is drainage adequate?

14.9.3Is ventilation adequate?

14.9.4Are processes properly separated

14.9.5Is the layout of equipment, facilities and processes suitable and appropriate?

14.9.6Is there any congestion in processing areas?

14.9.7Are storage conditions adequate for keeping goods? (e.g. dry/frozen goods etc.)

14.10Waste Control

14.10.1How does the organisation control waste?

14.10.2Are there sufficient waste control facilities in production area?

14.10.3Is waste been removed periodically from the production/storage areas adequate to prevent contamination?

14.10.4

How does the organisation treat the wasteDoes the waste disposal method comply with any relevant regulations?

15INTERNAL HACCP AUDIT

15.1Does the organisation have an internal audit plan for HACCP?

15.2At what frequency does the organisation conduct internal audits?

15.3Have the audit purpose, criteria, scope and methods been defined?

15.4How does the organisation ensure that the program covers all aspects of HACCP system?

15.5Have the auditors been trained?

15.6Have the responsibilities and requirements for audit been defined?

15.7How does the organisation ensure the independence and impartiality of the activities?

15.8Have the purposes of audit been achieved?

15.9Is the audit data utilised for improvement of the HACCP system?

15.10Have the audit results been documented?

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