Title Page
-
Conducted on
-
Prepared by
-
Location
Internal Audit
2.1-The HACCP Food Safety Team – Codex Alimentarius Step 1
-
1. Is there a HACCP plan developed?
-
2. Was the HACCP plan developed and managed by a multi-disciplinary food safety team that includes personnel responsible for the quality/technical, production operations, engineering, and other relevant functions?
-
3. Can the team leader demonstrate having in-depth knowledge of HACCP, competence, and experience, in HACCP/food safety processes?
-
4. Do the team members have specific knowledge of HACCP and relevant knowledge of the product, process, and associated hazards?
-
5. Are there training records in place to demonstrate that adequate trainings have been given to all the HACCP team members externally or internally?
-
6. Is there a representative of the senior management within the team?
-
7. Are there policy statements referring to HACCP or food safety, or evidence within management review meetings that HACCP/food safety issues are discussed or reviewed?
2.1.2
-
Does the scope describe all the products and processes included in the HACCP study?
2.2-Prerequisite Programmes
-
Has the site established environmental and operational programmes necessary to create an environment suitable to produce safe and legal food products?
-
Are the following included in the prerequisite programmes?<br><br>1. Cleaning and sanitising,<br>2. Pest Control<br>3. Maintenance Programmes For Equipment And Buildings<br>4. Personal Hygiene Requirements<br>5. Staff Training<br>6. Purchasing<br>7. Transportation Arrangements<br>8. Processes To Prevent Cross-Contamination<br>9. Allergen controls<br>
-
Are there clearly documented control measures and monitoring procedures for each prerequisite programme?
-
Are the prerequisite programmes’ control measures and monitoring procedures included within the development and reviews of the HACCP or food safety plan?
2.3-Describe the product (equivalent to Codex Alimentarius Step 2)
-
Is there a full description consisting of each product or group of products consisting of the following?<br>1. Composition<br>2. origin of ingredients<br>3. physical or chemical properties that impact food safety<br>4. treatment and processing<br>5. packaging system<br>6. storage and distribution conditions<br>7. Maximum safe shelf life under prescribed storage and usage conditions. <br>
2.3.2
-
Are the background information taken into account when preparing the HACCP plan suitable or relevant?
-
Are the background information up-to-date?
-
Do the information include all of the following? 1. the latest scientific literature<br>2. historical and known hazards associated with specific food products<br>3. relevant codes of practice<br>4. recognised guidelines<br>5. food safety legislation relevant for the production and sale of products<br>6. Customer requirements.
-
Are the sources available on request without using an internet search engine?
2.4-Identify intended use (equivalent to codex alimentarius step 3)
-
Are the intended use of the product by the customer, and any known alternative documented?
-
Are the consumer target groups defined and documented?
-
Are Handling and preparation defined and documented?
-
Is the Customer Supply chain defined and documented?
-
Storage defined and documented?
2.5-Construct a process flow diagram (equivalent to codex Alimentarius step 4)
-
Does the flow diagram indicate all the process steps, including all inputs and outputs?
-
Are all the following points considered and included in the flow diagram?<br>1. plan of premises and equipment layout<br>2. raw materials including the introduction of utilities and other contact materials (e.g. water, packaging)<br>3. sequence and interaction of all process steps<br>4. outsourced processes and subcontracted work<br>5. potential for process delay<br>6. rework and recycling<br>7. low-risk/high-risk/high-care area segregation<br>8. Finished products, intermediate/semi-processed products, by-products, and waste.<br>
-
Is the process flow diagram approved, signed, and dated?
2.6-Verify flow diagram (equivalent to Codex Alimentarius step 5)
-
Has the site-based HACCP team verified the accuracy of the flow diagram by a physical walk-through of the process within the production area?
-
Is the process flow diagram up to date?
-
Did the verification occur after the last review of the HACCP plan?
-
Are the full records of the diagrams and all verification activities maintained?
2.7-List all Potential Hazards associated with each process step, conduct a hazard analysis, and consider any measures to control identified hazards – Codex Alimentarius Step 6, Principle
-
Did the HACCP food safety team identify and record all the following potential hazards <br>1. Microbiological<br>2. physical contamination<br>3. chemical and radiological contamination<br>4. Fraud (e.g. substitution or deliberate/intentional adulteration)<br>5. Malicious contamination of products<br>6. Allergen risks (see section 5.3)<br>that are reasonably expected to occur at each step concerning product, process, and facilities?
2.7.2
-
Are the hazards identified in clause 2.7.1 evaluated against the following criteria<br><br>1. the likely occurrence of the hazard<br>2. the severity of the effects on consumer safety<br>3. the vulnerability of those exposed<br>4. the survival and growth of micro-organisms (i.e. those of concern to the product(s) within the scope of the HACCP or food safety plan)<br>5. the presence or production of toxins, chemicals, or foreign bodies<br>6. contamination of raw materials, intermediates, semi-processed products, or finished products.<br><br>
-
Are acceptable levels defined where the elimination of a hazard is not possible?
-
Are references made to legal requirements or scientific evidence to justify the acceptable levels (e.g. microbiological standards or presence of mycotoxins)?
2.7.3
-
Are Control measures required to reduce or eliminate the specific hazards been established?
-
Where control is achieved via the prerequisite programme, are made in the HACCP plan to the specific prerequisite that controls the hazard?
-
Are prerequisites used to control specific hazards subject to routine verification and monitoring, and with records maintained?
2.8-Determine the critical control points (CCP’s) (equivalent to Codex Alimentarius Step 7, Principle 2)
-
Has each control measure been examined to identify which are critical (i.e. to identify the points at which control can be applied)?
-
Are records available showing how this has been conducted and how decisions have been reached?
2.9-Establish critical limits for each CCP (equivalent to Codex Alimentarius Step 8, Principle 3)
-
Do all identified CCPs have defined critical limits?
-
Are the Critical Limits measurable?
2.9.2
-
Are documented evidence available showing how the control measures for CCPs and other controls, where appropriate, have been validated to ensure they control, reduce or eliminate the hazard to the<br>specified critical limit?
-
Does the validation demonstrate that if the control measures are followed as specified and the critical limits are met (at a minimum and maximum levels where a range is indicated), a consistently safe product will be<br>Produced?
-
Are there evidence from professional bodies, trade associations, historical processing data, scientific and technical literature, or legislation
2.10-Establish a monitoring system for each CCP (equivalent to Codex Alimentarius Step 9, Principle 4)
-
Has a monitoring procedure been established for each CCP?
-
Does the monitoring procedure include the following<br>1. the CCP to which the procedure relates<br>2. the staff (or staff role) responsible for monitoring the CCP <br>3. training requirements for responsible staff the frequency at which the monitoring is completed<br>4. instructions on how the monitoring is completed<br>5. the requirements for record-keeping (clause 2.10.2)<br>6. the critical limit(s).<br>
-
Does the monitoring have the ability to detect variation?
-
Are the results of monitoring activities recorded? At a minimum, include the following <br><br>1. date and time when the measurement was made<br>2. the result<br>3. the signature of the individual conducting the monitoring<br>4. the signature of the individual (e.g. the line manager) checking and verifying the record.
2.11-Establish a corrective action plan (equivalent to Codex Alimentarius Step 10, Principle 5)
-
Is there an established documented procedure detailing the actions to be taken when monitored results indicate a failure to meet a control limit or when monitored results indicate a trend towards loss of control?
-
If the procedure is available does it include<br>1. authorised personnel<br>2. immediate remedial action to be taken<br>3. quarantine procedures<br>4. disposal procedures for unsafe products<br>5. additional actions that may be required
2.12-Establish verification procedures (equivalent to Codex Alimentarius Step 11, Principle 6)
-
Are the HACCP plan and the controls managed by prerequisites, verified to ensure that it remains effective?
-
Does the verification studies include all of the following activities?<br><br>1. internal audits <br>2. review and trending of records (e.g. CCP monitoring records)<br>3. review of complaints by enforcement authorities or customers<br>4. review of incidents (e.g. product withdrawal or recall).
-
Are the results of the verification documented and communicated to the HACCP team as part of the review process?
-
Is there a planned schedule for the verification of the HACCP including prerequisites?
2.13-HACCP Documentation and Record-keeping (equivalent to Codex Alimentarius Step 12, Principle 7)
-
Are records kept to demonstrate that the HACCP or food safety plan, including the prerequisite programmes, are fully implemented?
-
Are steps in creating and reviewing the plan, records of control and monitoring procedures, and training records of staff available?
2.14-Review the HACCP plan
-
Are the HACCP plan and prerequisite programmes reviewed regularly, at a minimum of once a year, even if there have been no changes to the product range or processing methods?
-
Was the last HACCP plan review less than a year?
-
Are changes that may affect product safety, such as those listed below evaluated in the context of the HACCP plan before they are introduced, and the plan amended as necessary?<br><br>change in raw materials or supplier of raw materials<br>change in ingredients/recipe<br>change in processing conditions, process flow or equipment<br>change in packaging, storage or distribution conditions<br>change in consumer use<br>the emergence of a new risk (e.g. known adulteration of an ingredient or other relevant, published information, such as the recall of a similar product)<br>review following a recall<br>new developments in scientific information associated with ingredients, processes, or products.
