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Assessment

Preliminary Question

  • Has the organization developed, documented, and implemented a HACCP-based Food Safety Management System ?

The HACCP Team

  • Does the organization have a documented HACCP Team?

  • Do the HACCP Team members have the process skills and knowledge to develop and maintain the HACCP Plan?

  • Note: A multifunctional team is preferred.

  • Does the HACCP Team Leader have operational accountability within the organization?

  • Has the HACCP Team Leader attended a competency-based and assessed training course in the application of HACCP principles?

  • Has the HACCP Team Leader attended an equivalent training course?

  • Please list down the relevant training courses attended.

  • Does the organization employ a consultant to develop and maintain the Food Safety Management System?

  • Can the organization provide evidence showing that the consultant holds the appropriate qualifications?

  • How is the day-to-day management of the Food Safety Management System demonstrated?

HACCP Plan Scope

  • Is the scope of the HACCP plan defined and documented including:

  • Has the start and endpoint of the processes been set?

  • Is there documentation of the products covered?

  • Is the purpose of the Food Safety Management System defined and documented including the intent that all food safety hazards will be identified and controlled?

Product Description and Intended Use

  • Have product descriptions been developed and documented for all products included within the scope?

  • - Similar products can be grouped together.

    - Products that are processed using different food safety controls, processing techniques, or packaging methods require a separate product description.

  • Product description?

  • Composition?

  • Physical/chemical/microbiological characteristics?

  • Intended use?

  • Preservation method?

  • Storage, handling, and distribution?

  • Packaging?

  • Labeling requirements?

  • Shelf life?

  • Allergens?

Flow Diagram

  • Are documented flow diagrams in place?

  • Inputs?

  • Rework?

  • Outsourced process steps?

  • Waste management?

  • Does the HACCP team verify the flow diagrams annually and whenever there are any significant changes to the product or process?

  • Are records of verification available?

Hazard Analysis

  • Has hazard analysis been conducted and documented at each step of the process?

  • Has a hazard analysis been conducted for each raw material input?

  • Have all potential food safety hazards been identified and assessed to determine what needs to be prevented, eliminated or reduced to acceptable levels?

  • Have the hazards and the cause of the hazards been documented?

  • Have all potential allergenic hazards been considered, identified and documented?

  • Has each hazard been considered individually with each having its own separate risk assessment?

  • Has a risk assessment been conducted to determine which hazards are significant and which are not?

  • Have quality hazards been identified?

  • Has the risk assessment for quality hazards been considered separately from the food safety hazards?

  • For any hazard deemed significant, has at least one control measure been determined to prevent it from occurring or reduce it to an acceptable level?

  • Has a method been developed or have standard textbook methodologies been used for hazard analysis?

  • Has the method used been applied consistently throughout the Food Safety Management System?

  • Are sources used referenced?

  • Is a copy of the reference included in the documentation?

Determining Critical Control Points (CCP)

  • Have all hazards deemed to be significant CCPs?

HACCP Audit Table

  • Has a HACCP Audit Table been developed, documented and applied which includes each step of the process(es)?

  • Does this table list all the CCPs identified in the hazard analysis?

Establish Critical Limits

  • Have critical limits for CCPs been established and documented in the HACCP Audit Table?

  • Are the critical limits measurable and monitored during production?

  • Are the critical limits guidelines available through industry standards, legislation, and codes of practice or published research?

  • Has the organization undertaken a validation study to ensure said limits will control the significant hazard?

  • Is the validation data documented and maintained by the organization?

CCP Monitoring

  • Has the organization documented how each CCP is monitored to ensure it is within set critical limits?

  • Are monitoring procedures available?

  • What is being monitored?

  • Has the monitoring process been defined?

  • Has the location of monitoring been set?

  • Is the assigned person(s) to undertake the monitoring trained in correct methods?

  • Is this training assessed and documented?

  • Is the frequency of monitoring sufficient to ensure that the CCP is under control?

  • Are monitoring records available? <br>i) Maintained? <br>ii) Signed by the person responsible for the monitoring? <br>iii) Signed by a responsible reviewing officer? (

  • Are records properly maintained?

  • Are records signed by the person responsible for monitoring?

  • Are records signed by a reviewing officer?

  • Reviewing officer should not be the same person responsible for monitoring.

CCP Corrective Actions

  • Have CCP corrective actions been developed, documented, and implemented that define the action(s) to be taken when monitoring reveals that the critical limit has not been met?

  • Is there a procedure in place?

  • Does the procedures state what actions to take regarding the affected product?

  • Does the procedures state what actions to take regarding the person responsible?

  • What action is to be taken regarding the process?

  • Has a root cause analysis been undertaken to identify the problem and prevent recurrence?

Verification Activities

  • Are verification procedures in place to ensure the Food Safety Management System is being followed?

  • Do verification activities include the following?

  • Select all that apply.

  • Is a documented and maintained verification schedule in place?

  • What was the activity performed?

  • What is the frequency of the activity?

  • Who are the personnel responsible?

  • Are records maintained?

Food Safety Management System Review

  • Is the Food Safety Management System reviewed regularly?

  • An annual review is required.

  • What's covered by the Food Safety Management System review?

  • Select all that apply.

  • Is the Food Safety Management System reviewed whenever changes occur?

  • Are records of reviews maintained?

Internal Audits

  • Are internal audits of the Food Safety Management System conducted annually and sufficient to maintain the effectiveness of the system?

  • Is there a documented and implemented internal audit procedure?

  • Are there records of conducted internal audits?

  • Are internal auditors trained appropriately for the task?

  • Is there an internal audit schedule in place which indicates: <br>i) Elements to be audited? <br>ii) Audit scope? <br>iii) Dates to be maintained?

  • Have GMP inspections been conducted according to the product risk?

  • GMP inspections should be conducted monthly, at the minimum.

Microbiological & Chemical Testing Schedule

  • Have microbiological and/or chemical hazards been identified during hazard analysis?

  • Is a schedule of testing in place to confirm that CCP(s) are under control?

  • Is a schedule of testing in place to confirm that products or processes meet regulatory and customer requirements and to ensure quality and food safety parameters?

  • Are sampling methodologies and test limits documented that include the corrective actions for test results that are outside the limits?

  • Is testing conducted by suitably trained personnel?

  • Are test results reviewed by a responsible officer within the organization and within a reasonable timeframe?

  • Are corrective actions taken when results indicate that limits have been exceeded?

  • Are records of these corrective actions kept?

Shelf-Life Testing

  • Does the organization produce products with a shelf life of less than two years?

  • Is a schedule of shelf-life testing documented and maintained?

  • Are there tests to initially establish the shelf life indicated in the product description?

  • After initial shelf-life testing, are there tests top verify that stated shelf life is being met?

  • Are retention samples stored under typical conditions and in the commercial packaging for that product?

  • Did the end of shelf-life testing occur after the expiry date of the product?

  • For frozen products, has the end of shelf-life testing been carried out after the end of the frozen period has been reached?

  • Select which tests are included as end of shelf-life tests:

  • Have end of shelf life results demonstrated that the parameters of the product at the end of shelf life continue to meet the finished product specification?

  • For new products, has the process for determining the shelf life and assumptions been clearly documented?

  • Does the organization perform accelerated shelf-life testing?

  • This does not replace shelf life testing under typical conditions.

  • Select what is included in the shelf life testing schedule:

  • Are test results reviewed and signed by a responsible officer within the organization?

Finished Product Assessments

  • Is there a developed, documented, and implemented schedule for finished product assessments against finished product specifications?

  • Are records of these assessments maintained?

Monitoring and Corrective Actions of Verification Activities

  • Does the organization review the results of verification activities?

  • Is a documented schedule in place for reviewing monitoring activities and corrective actions of verification?

Customer Complaints

  • Does the organization have a developed, documented, and implemented process for reviewing customer complaints in relation to food safety and quality issues?

  • Is this process reviewed at least annually?

  • Does this process include a customer complaints register?

  • Do staff that log customer complaints have suitable training?

  • Are records of reviews, investigations, and corrective actions kept?

  • Are corrective actions prompt and appropriate?

Recordkeeping

  • Does the organization have a documented and controlled recordkeeping system relevant to the Food Safety Management System?

  • Select which of the following records are retained:

  • Are records retained for a minimum of 12 months or the shelf life of the subject product(s) (whichever is the greater) ?

  • Are records protected from damage or loss, easily accessible, and securely stored?

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