Tag Archives: accreditation

Best Practices for ISO 17025 Accreditation: Preparing for Your Food Laboratory Audit (Part II)

By Joy Dell’Aringa
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In Part I of this article, we explored the considerations a laboratory should initially evaluate when pursuing accreditation, as well as guidance from leading industry experts on how to prepare for an ISO 17025 audit. Here we will review what comes after the on-site assessment and provide practical user-based advice for preparing a response, common areas of non-conformance, and future changes to the ISO 17025 Standard.

The Response

Once the assessor has completed the audit, they will typically hold a closing meeting on-site where they present their findings, also referred to as deficiencies or non-conformances. For each finding they will document a specific reference to the standard as evidence and provide opportunity for questions and discussion. Most assessors will be open and conversational during this final portion of the assessment; laboratories are well suited to take advantage of this time. Some assessors will even brainstorm possible responses and corrective actions while onsite; this is valuable insight for the laboratories quality team and can help them get a jump on the response.

Depending on the accrediting body, the laboratory will have a certain amount of time to respond to the findings, usually 30–60 days. The anatomy of a well-assembled response will include a full corrective action report, complete with root cause analysis. Often, the assessor will also request supporting documents and records to show the effectiveness of a corrective action. Most laboratories will have forms to help guide users through the corrective action and root cause process. It is important to have a systematic approach to ensure your corrective action is thorough and balanced.

Determining root cause is a critical part of this exercise. Erin Crowley, CSO of Q Laboratories shares their approach. “We use a variety of root cause analysis techniques, but have found for our operation the principle of the ‘5 Why’s’ is very effective,” she says. “Don’t simply answer the singular deficiency. Accrediting bodies will want to know that you have addressed all variables that might be associated with a finding. For example, if a specific incubator was out of range on a specific date, don’t just indicate that someone fixed it and move on. Assess how they addressed the issue, any impact on data, what they did to react to it, and how they are putting systems in place to prevent it from happening in the future on any other incubator. You have to show the full process.”

Implementing procedures as an outcome of a corrective action can also bring challenges to an operation. As a national multi-site reference lab, Eurofins Quality Manager Peter Dragasakis must work with other departments and locations to deploy new or changed systems for compliance. “Sometimes the most challenging part of the entire audit process is coordinating internal stakeholders across other departments such as IT or complimentary analytical departments,” he says. “Coordinating a response in a timely manner takes full organizational cooperation and support.” Communication throughout the quality and operational arms of an organization is critical to a successful response. Often, accrediting bodies and laboratories may shuttle a response back and forth a few times before everyone is satisfied with the outcome.

Common Areas of Non-Conformance: Pro-Tips

While all areas of the standard are important to a conformant operation, there are a few key areas that are frequently the focus of assessments and often bare the most findings.

Measurement Uncertainty. Depending on the laboratories Field of Testing (FOT), Measurement Uncertainty (MU) can be captured in a multitude of ways. The process aims to systematically and quantifiably capture variability in a process. For chemical analysis this is typically well defined and straightforward. For microbiological analysis the approach is more challenging. A2LA’s General Manager, Accreditation Services, Adam Gouker says the reason many labs find themselves deficient in this area is “they don’t consider all of the contributors that impact the measurement, or they don’t know where to begin or what they need to do.” Fortunately, A2LA offers categorical guidance in documents P103a and P103b (for the life sciences laboratories, two of the of many guidance documents aimed at helping laboratories devise systems and protocols for conformance.

Traceability. There are several requirements in the ISO 17025 standard around traceability. In terms of calibration conformance, which accrediting bodies seem to have emphasized in the last few years, Dragasakis offers this tip: “When requesting [calibration] services from a vendor, make sure you’re requesting 17025 accredited service. You must specify this, as several levels of service may be available, and “NIST Traceable” certificates are usually no longer sufficient.” He also advises that calibration certificates be scrutinized for all elements of compliance closely. “Some companies will simply state that it is ‘ISO 17025 compliant’, [and] this does not mean it is necessarily certified. Look for a specific reference to the accrediting body and the accreditation certificate number. Buyer beware, there is often a price difference between the different levels of calibration. Always practice due diligence when evaluating your calibration vendor and their services, and contact the calibration service if you have any questions.”

Validation vs. Verification. One of the more nuanced areas of the standard lies in determining when a test requires validation, verification, or an extension, specifically when there is a modification to a method or a sample type not previously validated by an internationally recognized organization (AOAC, AFNOR, etc.). Certified Laboratories Director Benjamin Howard reminds us, “think of validation and verification as existing on a spectrum. The more you stray away from an existing validation, the more validation work is required by the analyzing laboratory.” For example, analyzing Swiss cheese for Salmonella by a method that has already been validated for soft queso cheese may require only minimal verification or matrix extension. However, a laboratory that is altering a validated incubation time or temperature would require a much more robust and rigid validation process. Howard cautions, “Accredited laboratories must be transparent about modifications, not only on their scope of accreditation but on their reports [or CofA’s] as well. Under FSMA, companies are now accountable to the data that their laboratories generate. If you see a “modification” note on your report, perform due diligence and discuss this with your laboratory. Ensure a proper validation of the modification was performed. “Additionally, the ISO 17025 standard and accrediting bodies do not mandate how a validation or verification should be done. Laboratories should have a standalone SOP that outlines these procedures using scientifically supported justification for their approach.

CAPA / Root Cause. A good corrective action / preventive action (CAPA) and root cause (RC) analysis program is at the heart of every sound quality system. “Corrective and preventive action (CAPA) processes can either add value or steal time away from the organization according the quality of the root cause analysis,” says Vanessa Cook, quality systems manager at Tyson Foods Safety & Laboratory Services. “CAPA might be the single greatest influence on an organization’s ability to continuously improve and adapt to change if diligence is given to this activity.” Investing in resources such as ongoing training in CAPA/RC programs and techniques are key components to ensuring a robust and effective CAPA / RC program.

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Best Practices for ISO 17025 Accreditation: Preparing for a Food Laboratory Audit (Part I)

By Joy Dell’Aringa
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An increasing number of food testing laboratories are seeking accreditation to the ISO/IEC 17025:2005 standard. This growth is chiefly due to regulatory implications, customer requirements, and trade organization recommendations and is seen across laboratory segments: third-party contract laboratories, private in-house laboratories, and government laboratories. ISO 17025 is the most common standard in the food testing industry and sets the guideline for “Laboratories Performing Microbiological and Chemical Analysis of Food and Pharmaceuticals”. Accreditation is known generally as a third-party attestation related to a laboratory, which conveys formal demonstration of competency that implies a reliable and consistent level of quality across an operation for a well-defined parameter of tests, often referred to as the “Field of Testing”. There are several qualified organizations that accredit laboratories to the standard; these organizations are referred to as Accrediting Bodies and are responsible for assessing facilities for conformity to a given ISO standard.

Audit Preparation Guidance

Initial Accreditation: Considerations & Preparation

When a laboratory initially entertains applying for accreditation, several factors should be considered. The cost and time commitment required to become initially conformant, and the on-going resources required to maintain conformity should be thoroughly examined in an overall benefit analysis prior to applying for accreditation. Management should be fully aware of the investment and perpetual commitment of becoming an accredited facility. Accrediting Bodies (ABs) provide resources and literature that can help guide laboratories through the initial audit-preparation phase. However, creating the systematic application of these guidelines that balances the quality and operational objectives of the organization are unique from laboratory to laboratory. Simply put: There is no cookie-cutter approach to accreditation.

Consultant Considerations

Q Laboratories in Cincinnati, OH first embarked on the path to ISO 17025 accreditation in 2009. James Agin, director of regulatory compliance at Q Laboratories and member of the A2LA Laboratory Accreditation Council took the lead on preparing for the initial assessment eight years ago. Q Laboratories was initially unfamiliar with the process, so they hired a consultant who was also an assessor to walk them through the process. “We took about four to five months with a consultant,” says Agin,. “In addition to creating the necessary systems, we gathered the troops and did a deep training on what ISO 17025 is, why we were pursuing it, and why it was important to our business.” The Q Laboratory team created a deep sense of ownership during the education and training process from the supervisors to the bench analysts, which they credit to their ongoing success years later. Erin Crowley, chief scientific officer at Q Laboratories suggests new labs consider hiring a consultant to ease them through the process and get them audit-ready. “If you’re not accustomed to having certain systems in place, a consultant can provide clarity and help initiate processes,” says Crowley. “Having an open forum with an expert helped give our entire team confidence.”

A consultant can streamline the initial process and help avoid some of the pitfalls in creating a robust quality management system for the first time. Tim Osborne, senior director of training services at A2LA offers advice for organizations when vetting a consultant. “While certainly not required, a qualified consultant may be a good asset to have in your quiver,” says Osborne. “Look for industry references and pay close attention to involvement in the industry outside of its own laboratory. Does this person work for an accrediting body? What are the areas of analytical expertise? Does this person also provide training for an accrediting body? If so, it is likely the consultant will offer the quality of services you need to be successful.” It is important to note that assessors and consultants should be upfront with the accrediting body to avoid conflict of interest issues during the actual assessment. Impartiality is critical within the assessment process.

Application Process

Accrediting bodies publish their own “readiness” documents. Laboratories seeking accreditation should request an itemized guide that walks the organization through each phase of the process. The following is a general outline:

  • Obtain copy of ISO standard (17025, 17065, 17020, etc.). Review any specific requirements relevant to your field; these are generally available in a checklist format allowing the laboratory to prepare through an internal audit process.
  • Determine estimated costs with the accrediting body
  • Obtain a copy of the accrediting body s assessor checklist. This usually has to be completed as part of application process
  • Prepare the intended draft scope of accreditation (outlining, specific tests/test methods, calibration parameters/ranges, certification schemes)
  • Implement the management system, and ensure personnel are aware and accept the content
  • Perform an internal audit to verify compliance with the conformity assessment standard requirements, accrediting body requirements, your own management system requirements, and applicable technical requirements
  • Perform a management review
  • Foreign applicants may need to translate supporting application documents to English
  • Identify one specific individual to be responsible for accreditation efforts and interactions with the accrediting body. Identify the “quality manager” who is in charge of the management system
  • Obtain, prepare, and submit the application for accreditation to the accrediting body

Once the initial assessment is complete and the final response and corrections to any deficiencies is in, the laboratory will be reviewed and considered for accreditation through the accrediting body. When the decision is made in favor of accreditation, the laboratory will receive their accreditation certificate, which will correspond to a specific location and set of tests (commonly referred to as a Scope of Accreditation (“Scope”) for the Field of Testing (“FOT”) for which they were assessed). Depending on the accrediting body, the certificate may be valid for one to two years, and will require re-assessment and surveillance at defined frequencies. The laboratory is responsible to maintain conformance to the ISO 17025 standard in between assessments.

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Changing Landscape for Selecting a Food Safety Contract Laboratory

By Bob Ferguson, Thomas R. Weschler
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A recent study of more than 100 food processing customers of food contract laboratories examined the key factors that make a commercial food laboratory competitive in the eyes of their customers. The details of this study, which was conducted by Strategic Consulting, will be presented at the Food Safety Consortium in December.

The 2016 Food Safety Consortium takes place December 5–9 in Schaumburg, IL | LEARN MOREThe volume of microbiology testing worldwide is growing annually at 6%. The study data, however, shows that the growth of microbiology testing at food contract labs is growing at twice that rate—12%—annually. This means that every year food contract labs are taking a larger share of the micro-testing market. Specific to pathogen testing, the situation is more pronounced. Two-thirds of the food processors surveyed conduct routine microbiology testing at their in-house lab, but the number willing to conduct pathogen analysis in-house has dropped to one-third. With more and more companies becoming wary about the risks and costs of analyzing pathogens in a plant lab, outsourcing continues to grow and the volume of total pathogen tests conducted at food contract labs is growing at more than 13% per year. Based on the data generated from the study, it can be deduced that, for the first time in the United States, the number of pathogen tests conducted at food contract labs now exceeds 50% of all pathogen tests conducted in the country. This is not only changing the face of microbiology testing, but it is also creating a very competitive market for laboratory services.

With this test volume now going to food contract laboratories, anyone who needs microbiology analysis has already (at least once) checked the qualifications of a food contract laboratory and validated that it has the right scope of accreditations, specific experience with product type, and proof that they can reliably meet test specifications and detection limits.

These basic qualifications, however, are “table stakes” in today’s highly competitive food safety contract laboratory market.

In the study, the most common answers to the question of the top decision criteria used when selecting a food contract laboratory for microbiology testing were, in order of importance, price, turnaround time, and dependability. When asked about testing of pathogens, most respondents reported that “accreditations” was their number one decision criteria, followed in order by the three previous factors of price, turnaround time and dependability.

A key distinction to understand in this analysis is the term “accreditations” was certainly used to describe formal lab accreditations, but it was also commonly used interchangeably with “expertise.”  In detailed conversations with buyers, it was clear that specialization and competence in pathogen testing was of primary importance and, in many cases, specific experience with the specific pathogen in which they were interested, and in most cases, experience with their specific product type (e.g., meat, dairy, processed foods, etc.).

Interestingly, although proximity to the plant ranked last of the six most common selection criteria, greater than 70% of the plant personnel interviewed reported that they use a food contract lab for pathogen testing that is within 100 miles of their production location. Based on the interviews it was clear that proximity was very important (and linked to turnaround time), but it also revealed that all of the major customers reported that all of the labs they would even consider had locations within a 100-mile radius of their plant. Of these labs, 60% offered a courier service to collect samples at the plant and deliver them to the lab. It is clear that proximity and a sample collection service, while once a point of differentiation, is now seen less as key selection criteria and more of a “table stake” for being considered at all.

Food processors, of course, run samples for testing for parameters other than microbiology. In this study, 78% of the companies surveyed ran tests for nutritional chemistry and, of those, 42% used an in-plant lab. In addition, 81% of the companies test for contaminants (e.g., pesticides, drug residues, metals) and of those, 55% run the tests in an in-plant lab. Of the companies that use a food contract lab for either types of tests, 60–65% (depending on the parameter) report sending samples to a lab that is more than 100 miles from their plant.

It is clear from this data that food processors are far more comfortable analyzing samples for nutritional parameters, contaminants and routine microbiology in an in-plant lab, but fewer are comfortable running pathogen tests in-plant. And while proximity is important for pathogen tests, it was not a top qualifier for nutritional or contaminant testing. As more and more pathogen samples are outsourced to food contract labs, however, it remains to be seen if the samples will “drag” samples for these other parameters along with them to the closer proximate labs. But it is clear that the contract labs with a network of locations that place them close to their customer’s locations and who have expertise in pathogens as well as a full range of other analyses will likely have an advantage.

The role of food contract laboratories will continue to grow, creating great business opportunities. The dynamics of this market, however, are clearly changing the ground rules and presenting companies with new risks and opportunities. Understanding this changing landscape will be of paramount importance to food contract labs, and their  success or failure will depend on their strategic decisions and how well they navigate these changing conditions.

These business environment changes are also essential for food processors to understand. As market conditions change, pricing, turnaround times, and add-on services available from food contract labs will also change, presenting risks and opportunities for processors. Food processors that understand these changes will also be able to take advantage and improve their testing programs.

Counting Food Laboratories

By Robin Stombler
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What We Think We Know

Food laboratories in the United States may voluntarily choose to become accredited to an international standard known as ISO/IEC 17025:2005. This standard outlines the general requirements for the competence of testing laboratories.

More recently, the FDA issued a final rule on the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Third-Party rule). Effective January 26, 2016, this final rule states that “for a regulatory audit, (when) sampling and analysis is conducted, the accredited third-party certification body must use a laboratory accredited in accordance with ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance in the validity and reliability of sampling methodologies, analytical methodologies, and analytical results.”  In short, for a segment of food laboratories, accreditation has become a necessary credential. At present, it remains a voluntary activity for most food laboratories.

There are accreditation bodies that accredit food laboratories to the ISO/IEC 17025 standard. The major accreditation bodies report on their individual websites which U.S. food laboratories are accredited under their watch.

To find the number of accredited laboratories, a quick search of the websites of four major food laboratory accreditation bodies, A2LA (American Association for Laboratory Accreditation), AIHA-LAP (American Industrial Hygiene Association – Laboratory Accreditation Programs, LLC), ANAB (American National Standards Institute-American Society for Quality), and PJLA (Perry Johnson Laboratory Accreditation) was performed on February 24, 2016. It yielded some debatable results. Here are some of the reasons for the skepticism:

  • The numbers are self-posted to individual websites. The frequency with which these websites are reviewed or updated is unknown.
  • Sites list both domestic and international laboratories. While foreign addresses were excluded from the count, those laboratories could perform testing for U.S. entities.
  • It can be difficult to separate the names of laboratories performing testing on human food versus animal feed.
  • There are several ways to duplicate or even exclude numbers. As examples, laboratories may be accredited within a food testing program, but may also be accredited under “biological” and/or “chemical” schemes—or vice versa.
  • In some cases, it is difficult to discern from the listings which laboratories are accredited for food testing versus environmental or pharmaceutical testing.

With all these caveats, the four major laboratory accreditation bodies accredit approximately 300 food laboratories. A2LA captures the lion’s share of this overall number with approximately 200 laboratories.

Let’s move to another source of numbers. A Food Safety News article about food testing and accreditation published in October 2013 states:

But, when it comes to testing our food, experts estimate that less than five percent of the food testing laboratories in the U.S. are accredited according to international standards…

Some believe that FDA will begin requiring accreditation for at least some significant segment of the food testing industry, of which the U.S. has roughly 25,000 laboratories. Whether that’s restricted to third-party labs – numbering roughly 5,000 – or will also include all food manufacturers’ internal labs is yet to be seen.

Using the writer’s sources, simple arithmetic finds 25,000 laboratories multiplied by the estimated 5% accreditation equals roughly 1,250 accredited laboratories in the United States. This, of course, falls far short of the 300 accredited laboratories noted by the major accreditation bodies. This is not to question either the writer’s sources or the websites of the accreditation bodies, but it does highlight an inconsistency in how we account for the laboratories testing our food.

To go a step further, Auburn Health Strategies produced in 2015, a survey of food laboratory directors, technical supervisors and quality assurance managers on the state of food testing. The survey, commissioned by Microbiologics, asked a series of questions, including: “Are the laboratories you use accredited?”  The respondents replied that, for their on-site laboratories, 42% were accredited and 58% were not. For their outside, contract laboratories, 90% of respondents stated that these laboratories were accredited and five percent did not know.

A second question asked: “Some laboratories are accredited to an internationally-recognized standard known as ISO 17025. Is this important to you?”  Approximately 77% of respondents answered affirmatively. Equally telling, 15% said they did not know or were unsure.

ISO 17025

What we do know is that there is not a definitive accounting of food laboratories—accredited or not. This lack of accounting can present very real problems. For example, we do not have a centralized way of determining if a particular laboratory has deficiencies in testing practices or if its accreditation has been revoked. Without knowing where and by whom testing is conducted, we are at a disadvantage in developing nationwide systems for tracking foodborne disease outbreaks and notifying laboratory professionals of emerging pathogens. We most certainly do not know if all food laboratories are following recognized testing methods and standards that affect the food we all consume.

What We Need Now

FSMA includes a provision calling for the establishment of a public registry of accreditation bodies recognized by the Secretary of Health and Human Services. The registry would also contain the laboratories accredited by such recognized organizations. The name and contact information for these laboratories and accreditation bodies would be incorporated into the registry. Rules for the registry have not yet been promulgated by the FDA, but should be. This is a small step toward greater accountability.

FDA Proposed Rule, Draft Guidance to Ensure Safe Imported Foods

By Food Safety Tech Staff
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The agency wants to establish a user fee program to facilitate audits.

About 15% of the U.S. food supply is imported. And within that figure nearly 80% of seafood, 50% of fresh fruit, and 20% of vegetables come from outside the United States, according to FDA. Under FSMA, the commitment to ensuring the safety of imported foods is a high priority. FDA is releasing a proposed rule, and a companion draft guidance document, to aid foreign entities in proving that they are meeting food safety import requirements.

The proposed rule, “User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications”, is scheduled for publication Friday, July 24. FDA has named the following key groups that would be charged fees:

  • Accreditation bodies (ABs) submitting applications or renewal applications for recognition in the third-party accreditation program
  • Recognized ABs and accredited CBs that are participating in the third-party accreditation program and subject to FDA monitoring
  • Certification bodies (CBs) submitting applications or renewal applications for direct accreditation

In addition to naming those subject to the user fee, the proposed rule defines how the fees would be computed and collected, the agency’s public notification process, and what happens if those subject to the fee do not pay it (i.e., suspension of recognition).

In the draft guidance, “Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards”, FDA makes recommendations on third-party auditor/certification body qualifications.  If finalized, the document will remain a companion guidance to the final rule.

What Constitutes a Successful FDA Audit?

By Sangita Viswanathan
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From the proposed third party accreditation rule, to GFSI audits, and needing more trained and experienced auditors, the process of auditing food facilities is undergoing a sea-change. What is the impact going to be on food companies, auditors, and the auditing process?

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, an expert team from The Acheson Group, comprised of Melanie Neumann, J.D., M.S., VP and Chief Financial Officer; Jennifer McEntire, Ph.D., VP and Chief Scientific Officer; Anne Sherod, M.S., Director of Food Safety and Valerie Scheidt, MBA, CP-FS, Director of Food Safety, answered key questions on conducting successful FDA audits. We present some excerpts below.  

How does the FSMA third party audit accreditation rule impact the audit process?

 

The purpose of the third party accreditation and certification audit is to issue a certificate for high risk foods or the voluntary qualified importer program. The main foundation of the standards that FDA is setting will come from the human preventative controls rule, the animal preventative controls rule, and the produce safety rule. Some standards may also come from the sanitary transportation rule and food defense rule. FDA will be appointing an accreditation body and this accreditation body will approve and monitor certifying bodies (CB). These CBs can be private companies or private individuals who will be authorized by the accreditation body to perform the audits and issue those certifications. 

 
Foreign governments can also be approved by FDA to act as a CB. Right now only New Zealand is approved and FDA is looking at approving Canada. We don’t anticipate any other country to be approved in the near future.;

Certifying bodies will have strict conflict of interest and reporting requirements to FDA. CBs must report to FDA within 45 days even if they’re just performing a consultative audit. They must also report to FDA if they see an issue that could lead to a Class I or Class II recall and they have to report to FDA before they report to the company that they are auditing.

 

Will a GFSI audit satisfy FSMA audit requirements?

GFSI audit requirements do not match the FSMA audit requirements, but they are not too different. Several of the schemes are very similar, and each scheme owner is making a concerted effort to become FSMA compliant. If an auditor is doing a GFSI audit, they do not need report to FDA before the company. The FSMA requirements of avoiding conflicts of interest, record keeping, and training may deter GFSI auditors from becoming Certifying bodies under FSMA. Unless FDA offers an incentive, there will be a shortage of FSMA CB auditors. 

 

What are the elements of a successful audit?

The number one goal of an audit is to identify risk. The audit needs to accurately describe the non-conformances against the audit standard to give your quality and operations team reliable and actionable data so they can mitigate that risk. The relationship between the auditor and the facility should be a partnership, add value, and build trust. The facility should learn from the auditor and the auditor should understand what the facility is doing to mitigate risk and promote food safety. Continuous improvement takes the feedback from the non-conformances and evaluates them against the organization’s goal around risk. Whether the results are from an announced, unannounced, internal, second, or third-party audit, continuous improvement is critical, and this requires commitment from management and will help the facility become audit ready. 

 

How can I ensure my auditor is up to the task?

Most audits use checklists. This goes for both the auditor and the audited. The checklist provides a standardized list of what’s expected and adds an element of order and control to the audit. It also allows for an effective way to quantify metrics. 

However, using a checklist alone can lead to minimum risk finding. The auditor needs to find a balance between being strategic and prescriptive. In order to be effective, audit protocols need to be periodically reviewed and updated. This is especially relevant with FSMA and holds true for internal and third-party audits. Check to see if the auditor’s checklist is pre-FSMA or post-FSMA. Ask the auditor when was the last time that they reviewed and updated their audit protocols. 

 

Will we have enough good auditors to meet the need?

No, we already don’t have enough good auditors. The implications of this are that we may get substandard audits from substandard auditors. The current model isn’t working and we need a new approach. Currently, most auditors have extensive prior experience working in industry and often become auditors after they retire.

We are creating auditors not through structured training. This model is not sustainable and has limited growth potential. It will not provide the level of training required for GFSI or FDA third party certification requirement. We need a training program for auditors who come right out of school. We need people to go to school for food safety and be able to become an auditor after graduation. Food safety needs to be incentivized at the university level. There should be a bachelors degree in food safety auditing. We need structured training and developmental opportunities for folks earlier in their career rather creating auditors at the end of their career.