Title Page
-
Conducted on
-
Prepared by
-
Location
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?
- Internal audits
- HACCP plan review
- Microbiological and chemical testing (if applicable)
- Shelf life testing (if applicable)
- Finished product assessments (if applicable)
- Review of monitoring records
- Record of corrective actions
-
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?
- Food Safety Policy
- Organizational chart
- Document control
- Verification activities
- Pre-requisite programs
-
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:
- Chemical testing
- Microbiological testing
- Organoleptic testing
- Physical testing
-
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:
- Type of testing to be conducted
- Testing to be conducted on each product or product type
- Testing to be conducted at least annually or when there is a significant change in the product or process
-
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:
- Monitoring of CCPs
- Corrective actions taken regarding CCPs
- Changes to the Food Safety Management System
- Pre-requisite programs
- Verification activities
- Validation activities
-
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?
Sign Off
-
Name and Signature