The Poultry Federation 2012 Poultry Workshop Review of the New FSIS Validation Guidelines

The Poultry Federation 2012 Poultry Workshop Review of the New FSIS Validation Guidelines

FSIS Validation Guidelines FSIS issued a Federal Register Notice on May 9, 2012 to clarify its requirements for validation by official establishments of its HACCP system Validation of CCPs and interventions or processes used to support decisions in the hazard analysis Also issued a draft FSIS Compliance Guideline-HACCP System Validation Comment period for both closed August 9, 2012 Will hold a public meeting before issuing final guidance HACCP Consulting Group, L.L.C. 2

FSIS Validation Guidelines Validation of a HACCP system involves two separate elements: The scientific or technical support for judgments made in designing the HACCP system Evidence derived from the execution of the HACCP plan to demonstrate that it is achieving the critical operational parameters documented in the scientific or technical support HACCP Consulting Group, L.L.C. 3

FSIS Validation Guidelines First element of a HACCP system validation is scientific support documentation Must demonstrate that HACCP system is theoretically sound Scientific support documentation can consist of: An article from a peer-reviewed scientific journal A documented study Data underlying a published guideline In-house data HACCP Consulting Group, L.L.C. 4

FSIS Validation Guidelines Scientific support documentation for first element should identify: The hazard (biological, physical, and chemical) The expected level of hazard reduction or prevention to be achieved All critical operational parameters or conditions necessary The processing steps that will achieve the specified reduction or prevention, and how these processing steps can be monitored HACCP Consulting Group, L.L.C. 5

FSIS Validation Guidelines Second element of HACCP system validation is inplant validation May include in-plant observations, measurements, microbiological test results, or other information demonstrating that the control measures, as written into a HACCP system, can be executed within a particular establishment to achieve the process s intended result HACCP Consulting Group, L.L.C. 6

FSIS Validation Guidelines Outlines the basic parameters for the proper validation of the food safety system Validation can be a complicated process depending on the process Industry has repeatedly not performed proper validation but there has been a lot of confusion involved from all parties

Validation Guidelines FSIS believes that validation should include the following: Scientific support did not include operating parameters A different product was validated Data did not support the effectiveness of the product Plant did not follow the procedures or process in the support document

Validation Guidelines FSIS believes that validation should include the following: Scientific References Data by experts to support unique processes Challenge Studies Supporting documents including in plant data Possible pathogen testing

Validation Guidelines FSIS believes that validation should include the following: Scientific Literature References Regulatory references such as Appendix A and B Regulatory performance standards such as poultry chilling regulations

Validation Guidelines Validation is expected for a variety of food safety related programs Interventions Pre Requisite Programs CCP s Purchase specifications Product Formulations Cooking Instructions

Validation Guidelines Supporting Documentation Identifies What hazard? What is the reduction of the hazard? What are the critical operational parameters? What are the steps in the process that the reduction occurs? How is the monitoring of the steps conducted?

Validation Guidelines Questions that you should address Did you identify all critical operational parameters in your support? Are those incorporated into the HACCP plan? Can you demonstrate that those parameters are being met? More questions on the Guidance material

Questions Validation Guidelines Each process is different and you should take the time to understand the needs Start with what does need to have validation Ask yourself what would someone need to know about this particular part of the food safety system Are you clearly defining the goal and are you able to demonstrate that you have?

Validation Guidelines Initial Validation Do you still have your initial validation? If not, then Prepare 90 days of data Decision documents Equipment operation data Testing history Operational parameter support Prepare a document on this and keep those forever

Validation Guidelines Validation Implementation Effective when final Federal Register is published. 6 months for large plants 9 months for small plants NR s issued in the meantime unless plant is deficient on scientific support

COMMON FSIS FINDINGS Questions