Melanie Neumann, Neumann Risk Services

Today’s Inspection and Audit Reality: The New Normal

By Melanie Neumann, JD, MS
Melanie Neumann, Neumann Risk Services

Industry’s “new reality” for inspection and audit readiness pivots on evolving its programs based on the expectations of today’s – and tomorrow’s – inspectors, auditors and customers alike.

Lasting Longer:

It makes a certain amount of sense that inspections would take longer to conduct and complete since there are more inspectors accessing and reviewing more records than pre-FSMA.§117.190 of the PCHF Rule alone contains a laundry list of implementation records required to meet only the risk-based preventive controls requirements of subpart C (the food safety plan requirements). These records include:

  • Documentation identifying the hazards requiring one or more preventive controls
  • Documentation for not establishing a preventive control
  • Records that document monitoring preventive controls
  • Records that document corrective actions
  • Records that document verification, as applicable, including:
    • Validation
    • Verification of monitoring
    • Verification of corrective actions
    • Calibration of process monitoring and verification instruments
    • Product testing
    • Environmental monitoring
    • Records review
    • Reanalysis
  • Records that document the supply chain program
  • Records that document training for PCQI and the qualified auditor

There are other record requirements relating to other sections of this rule, (e.g. if a facility meets Modified Requirements or Qualified Facility requirements, and subpart F relating to how records must be kept, who must sign, how long they must be retained, etc.).

Needless to say by reviewing the above list, record and document management will be key in today and tomorrow’s inspection and audit reality, in order to produce requested documents quickly, accurately and in compliance with regulations and customer expectations (lets not forget the 24 hour reporting requirement of the Reportable Food Registry (RFR) and increasing contractual requirements by customers, particularly in private label situations, where 2-4 hours is the “new normal” to report to a private label customer if a co-manufacturing facility may have a suspect or actual food safety incident at hand). For those still on manual/paper-based systems, now may be the time to consider technology as a means for managing risk.

Leveraging Technology:

Even the FDA is embracing technology folks (and no, this isn’t meant to be a slam, but rather a statement of fact). Case in point, although the first inspections are being conducted onsite for training purposes, inspections under the FSVP (Foreign Supplier Verification Rule) are intended to move to virtual inspections where relevant documents subject to inspection are requested via email by FDA and transmitted electronically from the FSVP food importer. Another example is the RFR, which requires the reporting of a “reportable food” to an online portal within 24 hours upon meeting certain criteria. If the government can embrace technology why does industry seem a bit slow to the party?

Some companies have done a stellar job of embracing this 21st century technological evolution, or as some may describe, revolution, in which we now live and work. Others, I am sorry to report, are woefully behind in leveraging technology to manage risk. GFSI recently released its new version 7.1 with new and modified standards. For example, V7.1 adds a couple of new clauses for each scope under Food Safety Management Requirements, such as purchasing from non-approved suppliers. The ripple effect is the CPO’s are in turn updating and releasing new versions of their own respective private standards. Layer on FSMA and the seven new rules that comprise it, which includes expanded records access authority by the agency, and companies are facing an exponential increase in the number of records to manage.

Simply put, it is becoming progressively more difficult to manage all required records and documentation in a paper-based system. As a result, more companies are evaluating software systems that can help manage key supply chain, production, traceability and distribution data so they can put their finger on the pulse of information when auditors and inspectors request information. Wise choice.

Not only should an electronic document management system help with speed to identify and access documents -it should also help with data trending (to the extent applicable). For example, if you are storing PC/CCP monitoring data on oven cooking temperatures, can the electronic system track and trend the data captured so that it can alert designated users when a PC/CCP goes out of limits? The best systems can, and the best-in-class companies are finding ways to reduce the human error factor by leveraging technology to better manage their risks and transforming the data into information through dashboards and trending reports so they can see where deviations or near misses may be arising. Yes, technology involves a capex request. But the ROI is almost always cheaper than a recall and certainly is less costly than the brand reputation damage that could result.

Considering Culture:

How strong is your food safety culture? How polished are your internal team’s “soft skills?” Be prepared to jump on the collaboration train with FDA—the paradigm is shifting from FDA acting as the “police” to becoming a “partner”. Specifically, FDA is taking initiative to learn more about food safety culture- a topic growing in importance to industry and one FDA historically had not fully understood or placed inspection metrics around. Public-private partnerships have formed including conference calls with FDA and industry to learn more about how industry is assessing and implementing food safety culture, as well as discussions with CPO’s to understand how these private standards are measuring this emerging topic. The net takeaway is that FDA is now looking at and assessing your food safety culture.

How is it being used? Food safety culture is factored into the scope of preventive controls inspections, according to Joann Givens, deputy regional food and drug director with the FDA, during a speech given at the Process Expo conference in September 2017. Further, Givens says regulators are receiving soft skills training to better interact with industry to create a spirit of collaboration and partnership. This level of training investment at the agency level clearly conveys the importance of providing the same type of training to industry– to ensure that we aren’t the ones with the poor “bedside” manner and poor interpersonal skills when FDA shows up on our doorsteps, and to ensure we are continuously striving to mature our food safety cultures.

Final Thoughts:

The “new reality” is that industry’s preparation for inspections and audits needs to evolve based on the expectations of today’s – and tomorrow’s – inspectors, auditors and customers alike. FDA is learning along-side industry during this first year or so of PCHF and FSVP inspections. Some may be skeptical of the FDA mantra “educate before and while we regulate”. However, it does appear through some of the first inspections that this is truly a mantra that is being embraced by the agency, and as such, industry is encouraged to work collaboratively and openly with the agency in this spirit of learning and collective mission of protecting public health and safety. It is a unique time of evolution and transformation in the food industry. Every player in the supply chain must find ways to transform to a new reality wherever they may be in the supply chain, and define a new normal to keep up with this evolution, or risk the cruel reality of being left behind as a memory of yesterday.

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About The Author

Melanie Neumann


  1. Jonn Cotter

    Wow Melanie, impressive article, but even more impressed with the Ironman finishes. I am also an avid runner but feel like I am slowing down. need to find the joy in it again. Thanks for the info.

  2. Patrick Bele

    Very good insight on what’s going with FSMA in the US. I wish our local authorities here in France would follow the mantra “educate…” as they are still in compliance mode… Auditors’ soft skills are indeed essential.

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