Lessons Learned from GFSI Audits

Food safety team: The most effective teams are multidisciplinary, but departments such as maintenance or procurement are often overlooked. A team leader should be named and documented either in the HACCP manual or in a job description. All members should be knowledgeable about HACCP methodology, either through initial education or ongoing training.

Product description: New products should be included in the HACCP documentation and should not be sold before going through the hazard analysis. Don’t forget to describe the unintended use of the product. For companies shipping abroad, the list of applicable regulations in destination countries must be identified.

Process flow diagrams: No standard will tell you how detailed flow diagrams should be, but some elements must appear. Often missing are the following: trash, packaging material, rework, and water treatment (provided water is an ingredient). When performing the on-site verification of these flow diagrams, do not forget to keep a record of this compulsory step.

Hazard identification: Biological hazards are usually well identified and addressed, but chemical and physical hazards are sometimes overlooked, even though they can be well controlled in the operation workshop. Pesticides, medicine residues, grease, cleaning chemicals, and heavy metals should not be forgotten at this step. Some GFSI standards even require that you assess deliberate contamination hazards, usually referred to as bioterrorism. Keep records of the hazard assessment against likelihood and severity.

CCP: The definition of CCP can lead to endless debate between auditor and auditee—and between auditors themselves. If you consider a control measure/processing step a CCP, you must define the critical limits, the record for monitoring, and the corrective action, in case the CCP is out of control. No product should be released until all CCPs are found compliant. As a rule of thumb, if you find more than 10 CCPs, some are probably not actual CCPs.

Validation is another hot topic with CCP. Often misunderstood, the validation of a CCP means making sure the control measure will achieve its objective in terms of acceptable level of food safety. Validation should answer whether the CCP can consistently reduce the hazard to an acceptable level.

Review/management of change: The HACCP study should be reviewed at least annually. More importantly, any change that could affect food safety should be reviewed prior to implementation. The list of changes in that category can be quite long, including recipes, ingredients, vendors, equipment, regulations, and customer requirements. Meeting this demanding requirement requires efficient internal communication within the manufacturing site and also with headquarters.

Whichever program you choose, the auditor will have limited time to assess all clauses of the standard.

Site Standard Issues

Not all factories are equal with regard to site standards. Recently built sites with state-of-the-art equipment will have a strong competitive advantage over older facilities that need to invest in upgrades.

External standards: Most GFSI standards ask that the external site environment be assessed regarding food safety. Sometimes misunderstood, this clause means that you should be aware of your neighbors’ activities and understand whether those activities could affect the safety of your products.

Security: U.S. factories are usually well prepared with regard to security requirements, although there can be implementation issues, such as doors that are left unlocked or security systems that are disabled to ease traffic flow. Make sure that your internal training program includes security and that appropriate records are maintained.

Segregation: Usual findings are lack of segregation between processes and cleaning of utensils that could lead to cross-contamination.

Building: Although recent buildings are more likely to meet GFSI requirements, well-maintained or upgraded older facilities can still do so. Our most common findings are external doors that do not fit closely, unprotected light in a production area, and dirty air filters. A thorough visual inspection should prevent most of these issues.