Fine Tune Your Compliance with Validation

Auditing for food safety and quality system compliance is usually a two-step process. Initially, the documentation system of a supplier is examined to see if all the requirements of the conforming scheme have been met. The second step is auditing the actual practices taking place at the supplier to see if they are in conformance with the documentation and scheme requirements.

One key to conducting effective audits is understanding that the term validation is used to cover not only the critical control points (CCPs) in a HACCP plan, but also all the applicable GMP-related activities that form the prerequisite programs underlying the HACCP system, such as:

• Equipment used in manufacturing;
• Equipment used to control the environment(s) where the product is manufactured or stored;
• Utilities with product contact (e.g., water systems, compressed gases, air);
• HVAC systems;
• Alarm systems that monitor utilities and air handling for process and storage areas;
• Analytical methods;
• Analytical instruments;
• Computerized systems (e.g., document control systems);
• Cleaning processes; and
• Manufacturing processes.

During the development of HACCP plans and the hazard analysis, decisions are typically made to exclude points as CCPs based on the fact that these activities are validated and are thus under control in the prerequisite programs. Typically, audits concentrate on the validation of the CCPs in the HACCP plan and do not fully consider the entire HACCP system and the requirement that all the related prerequisite programs be under control as well. Audit findings that any of these activities are not being controlled adequately can have a serious impact on the HACCP system, negating the original decisions in the hazard determination of a CCP in the HACCP plan.

For HACCP-based systems that have been implemented, change management is a critical process that must be well defined and followed for formal documented reassessment of the HACCP plan. An auditor should be looking for changes made to or omissions from the current HACCP plan in such areas as:

• Raw materials or source of raw materials;
• Product formulations;
• Processing methods or systems, including computers and their software;
• Packaging;
• Finished product distribution systems or the intended use or intended consumers of the finished product; and
• Rate or type of consumer complaints.

As an audit guide specific to reviewing initial and existing HACCP plan validations, the NCIMS HACCP Validation Checklist represents a generic model that can be used.

Conclusion

Conducting an effective audit for many of the food safety and quality system schemes today can be a difficult task due the sheer number of requirements that must be evaluated in a short period of time. There can be a tendency to give equal weight and time to evaluation of all the requirements, because there may be hundreds of line items that must be audited.

When auditing for compliance to any food safety scheme, a requirement that something must be controlled effectively should be a red flag for the auditor to budget sufficient time in his audit planning to obtain sufficient objective evidence to validate that the requirement is truly being met.

Arthur Rumpf is a senior technical consultant at UL-STR in Canton, Mass., a global provider of quality assurance testing and supply chain support services for the food industry. UL-STR provides third-party testing, inspection, audit, and responsible sourcing services for a wide range of consumer products. Rumpf can be reached at [email protected].