FSMA’s Challenges and Opportunities in Auditing
FSMA requires new auditor training on a global scale, which represents a massive challenge to the auditing community. Auditors need to learn how to apply the new preventive controls technical knowledge, fully comprehend the impact of the complete scope of FSMA regulations on local and global markets, and incorporate all FSMA driven audit program updates into their portfolios. Previous situations that necessitated a similar global change highlighted certain areas of concern that will only be magnified under the scope and scale of FSMA’s regulatory changes.
Lack of Auditor focused training: learning “about something” is very different from learning “how to audit something”. Most of the existing training and publicly available information is directed toward industry, leaving the auditing community to develop the ‘how to audit it” component.
Training inconsistencies: developing effective training materials for auditors requires more than simply listing technical information and new regulations. It requires professional expertise in other fields to ensure the appropriate learning objectives are established and the materials and delivery methods used can effectively meet those objectives. The burden of foreign language translation and interpretation of FSMA’s regulations to support auditor training development outside the US will only exacerbate this situation.
Auditing tool variability and usability: Audit checklists focus primarily on the technical content and often ignore professional expertise and other inputs that could enhance Stakeholder’s use of the report. How an audit question is written can have a tremendous impact on the auditor’s ability to apply the concept during an audit. Broadly written questions can result in the need for explanatory written comments from the auditor just to clarify what was observed. Compound questions can leave the auditor without a correct way to respond if there is no clear “all yes” or “all no” response. The effect is more pronounced in global programs where terminology variations can reduce auditor comprehension of audit requirements. Even when the technical content is well covered, the report does not always provide the detailed information needed in language easily understood by personnel responsible for reviewing the reports. Poorly developed audit checklists and tools are one of the primary issues affecting auditor performance and calibration.
Opportunities for Collaboration
FSMA’s challenges represent a chance to solve these longstanding issues through a groundbreaking collaborative effort among Auditors and the auditing community. This represents a unique opportunity to pool resources and combine talents under the AFSAP umbrella. To achieve this herculean task in a timely and cost effective manner, AFSAP has organized a robust committee structure that includes three Technical Audit Committees (TAC’s) based on the primary product safety rules for Human Food, Animal Food and Produce Safety, that are supported by the Technical Advisory Board (TAB). The International Committee is tasked with outreach and education among those likely to have the greatest need for the advantages of membership.
Auditing and Auditor Advocacy
FDA outlines broad requirements for audit reports that could be interpreted differently by the auditing entities engaged in compliance auditing under FSMA. Rather than speculating what FDA’s expectations are, AFSAP’s Board Chair and Regulatory Affairs Committee members are already hard at work developing a dialogue with key FDA personnel and other interested Stakeholders to facilitate their participation in the development process. Incorporating the feedback and input of all Stakeholders in the final documents and programs will demonstrate the audit documents and training programs offered by our members exceed all expectations and raise the bar across the entire food safety auditing industry.
Professional Training for Auditors