The FSSC 22000 prerequisite programs act as the foundation for each FSSC 22000-certified food safety management system. The prerequisite programs control the environment and operating conditions in the facility, thus addressing the gaps that the HACCP plan does not cover. As an Indian manufacturer or exporter interested in the FSSC 22000 certification, one should be familiar with the FSSC 22000 prerequisite programs because your auditors’ success depends on how well you understand the FSSC 22000 PRPs, which ultimately determines whether your audit brings out some observations or non-conformities. This article presents to you all the FSSC 22000 prerequisite programs, including the relationship between FSSC 22000 PRPs and ISO 22000 PRPs.
What Are FSSC 22000 Prerequisite Programs
Pre-requisite programs of FSSC 22000, or PRPs, are the basic elements necessary for the company to create the conditions for the hygienic production, storage, and distribution of food products. These elements include infrastructure, personnel practices, pest control, sanitation, and supplier control. In contrast to HACCP, which deals with the identification of certain risks, PRPs deal with the environment in which these risks may occur.
FSSC 22000 PRPs are developed on the basis of the ISO 22000 management system using its technical specifications. That is why FSSC 22000 is considered a very strict standard certified by the Global Food Safety Initiative (GFSI). As a result, the PRP document is taken into account by the certification authorities no less than HACCP.
In addition to complying with the compliance requirement, there is another reason for Indian organizations to implement FSSC 22000 PRPs when exporting their goods to EU, US, and Middle Eastern countries. These days, it has become very common for buyers to require evidence of implementation of PRPs before carrying out the audit just to get an idea of how efficient the manufacturing processes are at the facility in question. Poorly implemented or lack of proper PRPs can be the biggest reason for delay in the buyer qualification process before even discussing the certification issue.
In this regard, it is also important to understand the distinction between operational PRPs (oPRPs) and normal PRPs. While PRPs normally mean general requirements about hygiene in the plant including pests and personnel hygiene, oPRPs relate to specific steps in the manufacturing process where risk analysis has found that there is more risk. This must be clearly made in FSSC 22000 documentations.
Complete List of FSSC 22000 Prerequisite Programs
The full range of FSSC 22000 prerequisites in relation to food manufacturing comes from ISO/TS 22002-1, together with the extra requirements of FSSC 22000. The following table identifies each one with its particular area of concern.
| PRP Category | Primary Focus Area |
|---|---|
| Construction and Layout of Buildings | Site location, building design, and internal flow to prevent contamination |
| Layout of Premises and Workspace | Product flow, zoning, and separation of high-risk and low-risk areas |
| Supplies of Air, Water, and Energy | Potable water quality, compressed air, ventilation, and utilities |
| Waste Disposal | Collection, storage, and removal of waste and by-products |
| Equipment Suitability and Maintenance | Hygienic design, calibration, and preventive maintenance |
| Management of Purchased Materials | Supplier approval and incoming material verification |
| Prevention of Cross-Contamination | Physical and procedural controls between processes and materials |
| Cleaning and Sanitation | Cleaning schedules, validated methods, and verification records |
| Pest Control | Monitoring, prevention, and control of pest activity |
| Personnel Hygiene and Facilities | Handwashing, protective clothing, and health screening |
| Rework | Controlled handling and traceability of reworked product |
| Product Withdrawal and Recall Procedures | Traceability systems and recall simulation testing |
| Storage and Warehousing | Temperature control, stock rotation, and segregation |
| Product Information and Consumer Awareness | Labeling accuracy and allergen declarations |
| Food Defense, Biovigilance, and Bioterrorism | Site security and vulnerability assessment |
| Allergen Management | Identification, segregation, and cross-contact prevention |
| Environmental Monitoring | Pathogen and hygiene indicator sampling programs |
| Food Fraud Mitigation | Vulnerability assessment and mitigation plan for economically motivated adulteration |
When appropriate, the following ISO/TS 22002 sector-specific sections will be used: Part 2 for catering, Part 3 for agriculture, Part 4 for the manufacture of food packaging materials, and Part 6 for animal feed and pet food production. Choosing the right standard is the first step in implementing FSSC 22000.
Read more: fssc 22000 for rice mills and grain processors
ISO 22000 PRP Requirements and FSSC 22000 Prerequisite Programs
The ISO 22000 clause 8.2.4 stipulates that organizations shall have established, implemented, and maintained PRPs but it does not specify the technical elements. FSSC 22000 plugs this gap by requiring a particular technical document, ISO/TS 22002-1, together with other FSSC provisions such as food fraud, food defense and allergen management. As far as practice goes, ISO 22000 PRP requirements lay down the management system requirement whereas FSSC 22000 PRPs offer a detailed technical checklist that will be audited on the ground.
In this scheme of things, an organization cannot depend on the broad good manufacturing practices. Every single FSSC 22000 PRP has to be in writing, have an owner, be monitored at a certain frequency and be traceable to hazard analysis of the organization.
Certifiers carrying out an audit on an organization using ISO 22000 for PRP requirements would also want to see that the PRP was selected in light of risk and not because it was picked off-the-shelf in some general template. An organization producing ready-to-eat dairy products would require a very different environmental monitoring plan than one packing dry spices. Certifiers will usually request organizations to explain how they came up with their PRPs using the hazard analysis from their site.
How to Implement FSSC 22000 Prerequisite Programs
Companies are always wondering how to introduce the Prerequisite Programs in FSSC 22000 certification without reproducing their quality documents. The following order is what the vast majority of certification authorities expect to see at the time of stage 1 and stage 2 audits.
- Gap analysis should be done based on ISO/TS 22002-1 standards in order to determine which PRPs exist and which don’t.
- Determine the right ISO/TS 22002 part depending on the extent of activities, e.g. production, packaging or catering.
- Develop documentation of the procedure of the PRP indicating its purpose, scope, responsibilities and frequency of monitoring.
- Assigning the responsible person for each PRP and ensuring the training of staff regarding the developed procedure.
- Develop the monitoring and verification documentation such as cleaning, pest control and calibration documentation.
- Incorporate the PRPs into the HACCP or food safety hazard analysis so that any failure of the PRP would lead to correction.
- Internal audits should be done before the external auditing focusing on the PRP aspect.
- Evaluate the effectiveness of the PRPs during the management review.
Following this order ensures a facility has an audit-trail process that can be defended and is the heart of any effective FSSC 22000 implementation guide that consultants and internal quality professionals utilize. While timelines depend on the size of the facility and where they are in their journey of maturity, Indian manufacturers who have transitioned from a simple hygiene program to a structured PRP system should expect three to six months before the stage 1 audit.
Just as important as ensuring documentation exists is the documentation being deep enough. If a cleaning process mentions only the chemical and frequency, that will not suffice for an auditor expecting the contact time, concentration and verification methodology, including ATP testing or visual inspection certification. Ensuring this documentation at the start of each FSSC 22000 prerequisite program will prevent rework after stage 1 audit reveals deficiencies.
Common Challenges in Implementing FSSC 22000 Prerequisite Programs
The certification bodies always identify similar deficiencies in the FSSC 22000 prerequisite program audits. Proactively tackling them helps to minimize the possibility of any non-conformity.
- Cleaning validation documentation that is incomplete or inconsistent shift to shift
- Allergen cross-contamination control measures that exist only on paper, but are not practiced on the production line
- Pest control monitoring that is outsourced but not audited internally
- One-off instead of periodic food defense/food fraud risk assessment exercise
- Inadequate connection between the PRP monitoring results and the corrective action procedures within the HACCP plan
- Calibration of the monitoring equipment which is delayed compared to the frequency stated in the schedule
- Failure to update the training documentation after PRP change
These problems can be traced back to the same source: the PRP is viewed as an audit tool but not as a working control tool used daily by floor staff. Plants where ownership is made clear and PRP review is incorporated into the existing shift turnover process will address the problem more quickly than plants that leave enforcement of compliance up to the quality department alone.
Benefits of Strong FSSC 22000 Prerequisite Programs
Firms that implement strong FSSC 22000 PRPs experience rewards that go far beyond just obtaining certification. Having a comprehensive system of PRPs eliminates product recalls, speeds up qualification procedures by potential buyers, and builds a defense mechanism in case of an inspection or customer complaints.
- Fewer audit deviations and quicker corrective actions every year
- Enhanced buyer trust when doing export supplier validation, especially for Europe and the Middle East
- Less time lost due to equipment breakdowns, by doing preventive maintenance as part of the PRP plan
- Faster determination of the cause of any food safety issue, since there is monitoring data already available
- An underlying structure that allows integration of additional management systems like ISO 9001 and SA 8000 without creating duplicate documentation
The advantages mentioned above accumulate over time. For instance, a factory which is already going through the second or third cycle of certification will spend much less time dealing with corrective actions compared to a facility which considers PRP simply a part of the certification process.
Read more: FSSC 22000 for seafood exporters
Key Takeaways for FSSC 22000 Prerequisite Programs
- The FSSC 22000 Prerequisite Programs are the basic hygiene and operation controls necessary in addition to HACCP.
- ISO/TS 22002-1 contains the full set of FSSC 22000 Prerequisite Programs for food manufacturing facilities.
- ISO 22000 PRP requirement is the management commitment; FSSC 22000 is the technical one that auditors verify.
- Implementation should be performed in a logical order – gap analysis, documentation, training, monitoring, and evaluation.
- Allergen management, food defense, and food fraud prevention are common causes of audit nonconformities.
The implementation of FSSC 22000 pre-requisite programs is not just about documentation. It needs to be owned continuously by all production, maintenance, and quality departments in collaboration and in coordination with the review process at the management level where actual action is taken based on the performance of PRPs and not just noting down the information for the record. Organizations that have developed this culture initially continue to do so in each recertification cycle with much less resistance.
FAQs on FSSC 22000 Prerequisite Programs
What are the prerequisite programs in FSSC 22000?
These are the basic hygiene and operational controls detailed in ISO/TS 22002-1, which serve to provide a certified food safety management system.
How do you implement PRPs for FSSC 22000 certification?
Perform a gap analysis, create a documented PRP, perform training, and keep monitoring records that are related to the HACCP plan.
What is the complete list of FSSC 22000 prerequisite programs?
There are 18 categories ranging from facility design to food fraud prevention.
How many PRPs are required under ISO/TS 22002-1?
According to ISO/TS 22002-1, there are 18 prerequisite programs for food processing factories.
Is food defense a mandatory FSSC 22000 prerequisite program?
Yes, food defense and vulnerability assessment are additional requirements in the FSSC 22000 standard.
What is the difference between PRPs and HACCP in FSSC 22000?
While PRPs ensure hygienic conditions, HACCP focuses on controlling certain hazards at the critical control point.
How often should FSSC 22000 prerequisite programs be reviewed?
These programs must be reviewed at least once per year during management review, or when process/facility changes occur.
