1. Prerequisite Programs
1.1 Are all PRPs adequately defined and documented (a GMP standard should be used to verify this)?
1.2 Are PRPs regularly monitored and verified?
1.3 Have PRPs been validated where applicable (e.g. cleaning methods and schedules, hand sanitizing, raw material inspection, etc.)?
1.4 Has complete traceability been established?
1.5 Is effective vendor auditing regularly performed?
1.6 Is adequate training performed and is its effectiveness monitored?
2. HACCP Team
2.1 Has a qualified food safety team leader been appointed?
2.2 Has the team received adequate training?
2.3 Does the team have enough scientific expertise to address all hazards (biological, chemical, physical)? If not, have suitable consultants been employed?
2.4 Does the team meet at regular intervals? Are minutes kept? Are team decisions carried out in a timely manner?
3. Description of Product
3.1 Have all ingredients and sub-ingredients been identified?
3.2 Have microbiological and chemical characteristics been established and are they validated?
3.3 Has the intended use been properly defined?
3.4 Has the possibility of inadvertent misuse been identified?
4.1 Do flowcharts cover the entire process including sub-contracting, external warehousing, rework, special products, limited editions, etc.?
4.2 Are raw ingredients and packaging materials included in the flowchart?
4.3 Are flowcharts detailed enough to allow adequate hazard identification?
4.4 Are flowcharts verified?
5. Hazard Identification
5.1 Have all potential hazards been identified and documented?
5.2 Have hazards associated with ingredients been identified and documented?
5.3 Have hazards associated with nutritional inadequacy been identified and documented?
5.4 Are hazards specific (species of bacteria, type of contaminantâ€¦)?
6. Hazard Evaluation
6.1 Has an adequate methodology for determining risk been adopted? Is the methodology based on evaluation of at least likelihood and severity?
6.2 Has the correct level of severity been assigned to each hazard?
6.3 Has the correct level of likelihood been assigned to each hazard? Has supporting evidence been provided?
6.4 Has significance been determined based on likelihood and severity and is this determination compatible with the methodology?
6.5 Has the acceptable level been determined for each significant hazard? Has this been justified?
7. Identification of Control Measures
7.1 Has a methodology for determining CCPs, such as a decision tree, been adopted? Is it adequate?
7.2 Has each significant hazard been assigned a CCP or an oPRP?
7.3 Has the effectiveness of the control measure applied at each CCP or oPRP been scientifically validated? Are validation records available?
7.4 Are all employees familiar with the CCPs and/or oPRPs?
8. Critical Limits
8.1 Have critical limits been set for each CCP?
8.2 Have the critical limits been scientifically validated? Are validation records available?
9.1 Have monitoring practices been written in a procedure?
9.2 Is monitoring performed by skilled employees with a thorough understanding of the CCP and its importance?
9.3 Is the actual control measure being monitored? The hazard itself should not be the target for monitoring.
9.4 In batch production, does monitoring cover every single batch?
9.5 In continuous processes, continuous on-line monitoring is preferable. If this is not possible, is monitoring frequency adequate? When periodic monitoring is performed, frequency must be high enough ensure sufficient control in case deviation is detected.
9.6 Are oPRPs adequately monitored?
9.7 Are monitoring activities properly recorded and are records kept at least throughout the product's shelf life?
10. Corrective action
10.1 Are there clear and detailed written guidelines describing exactly must be done in the event of a deviation for each CCP and oPRP?
10.2 Are relevant employees familiar with these guidelines?
10.3 Have corrective action guidelines been validated to prove their adequacy?
10.4 Do the corrective action guidelines describe what to do with potentially non-conforming material? i.e. how it is segregated, marked and blocked?
10.5 Do the guidelines describe in detail all of the possible dispositions for non-conforming materials? i.e. rework, reprocess, re-designate, destroy, etc.
10.6 Is it clear who has authority to decide on the destiny of non-conforming material and what criteria are applied?
10.7 Do the guidelines provide guidance on how to resume operation following a CCP deviation?
10.8 Do the guidelines require that action be taken to eliminate root causes of failure in order to prevent recurrence?
10.9 In organizations certified to ISO 9001, are the corrective action guidelines compatible with clause 8.3 (control of non-conforming product) and clause 8.5.2 (corrective action)?
10.10 Are corrective action events properly recorded and are records kept at least throughout the product's shelf life?
11.1 Are written verification procedures in place for each PRP, CCP and oPRP?
11.2 Do the verification activities provide adequate proof that all elements of the food safety management system are actually in place? Is there a process in place to prove that monitoring is being performed as required?
11.3 Is there a pre-shipment release procedure in place, providing assurance that each batch of finished product has been adequately controlled at each CCP?
11.4 Is there a process in place to verify that measuring devices used for each CCP are calibrated and accurate? If a deviation in measuring equipment accuracy is detected, is corrective action as described in item 10 above initiated?
11.5 Do the verification activities provide adequate proof that the goals of the food safety management systems are being achieved?
11.6 Are verification activities recorded and are records kept at least throughout the product's shelf life?
11.7 Does verification include at least internal audits, trend analysis, analysis of customer complaints and routine product testing?
11.7 Is there evidence of corrective action when verification shows inadequacy of any element of the food safety management system?