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

Audit

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:

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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Ongoing Accreditation: Best Practices for Remaining Audit-Ready & On-Site Preparation

Accredited laboratories face the task every one to two years of being re-assessed to maintain their accreditation (either by surveillance or full reassessment). During the re-assessment process, the laboratory will undergo a similar process as with the initial assessment, sans applications. The laboratory also has an opportunity to add or change any FOT’s on their Scope.

Experienced laboratories maintain an “audit-ready” approach to audit preparedness. Tyson Foods Safety & Laboratory Services has held ISO 17025 accreditation since 2002. Vanessa Cook, quality systems manager for Tyson Foods says, “Rather than preparing for audits, we have an expectation to be audit-ready at all times by implementing the many processes involved in the laboratory in a manner that is self-sustaining.  We try to design our processes to have quality and compliance built into each step with acceptance criteria defined.” This approach has multiple advantages, including increased confidence in data and management systems between audits and decreased “crunch time” preparation as assessment dates approach. Treat audit preparation as a continuous process, not a singular event leading up to the audit itself. Cook also stresses the importance of staff preparation. “All team members have a role in driving continuous improvement, and how all lab tasks support the achievement of the quality objectives and the quality policy,” she says. “If team members understand the expectations of processes they participate in, then they are well prepared and able to be confident when audited.”

The overall tone and approach to assessments and assessor interaction, while often intangible, can be a key factor to assessment success. “Audit Attitude” guidance can be communicated in a variety of ways, from specific written policies and SOP’s, to informal incorporation into training programs. Accredited laboratories are advised to have a defined and consistent culture around how personnel interact with assessors throughout the process. Benjamin Howard, laboratory director at Certified Laboratories of the Midwest  (an ANAB Accredited facility),  begins this coaching process at the time of hire. “For a new person coming into our operation, we train them to be open and receptive to the assessor and their questions,” he says. “It can take a bit of experience, but our seasoned employees can navigate the nuances of the assessor interaction. The key is to answer questions directly and provide information in a clear and confident manner.”  Howard also remarks on the advice he gives employees when they are unsure: “They should not guess.  What is important in those cases is to acknowledge your uncertainty and then to demonstrate to the auditor that you know where to get that information if and when you need it.”

Internal organization and communication is critical to maximizing time with your assessor. Common best practices include:

While no amount of preparation can guard from the unknown, it is the preparation that equips a laboratory to deal with unknowns that inevitably crop up during an audit. Peter Dragasakis, quality manager at Eurofins Microbiology Laboratories is the corporate representative onsite during all audits of the wide network of facilities. “When gaps arise during audit preparation, or even during an on-site assessment, be upfront about them and work with your assessor to show how you are addressing the problem.” Common issues such as high turnover rates can expose training record gaps in an operation, and will likely result in a finding (deficiency). Dragasakis reminds his team: “The assessor is not here to harm us; we are their customer. They are here to ensure we meet requirements and identify gaps to improve our overall systems.” Technician interviews are another common area of gap exposure. Dragasakis encourages honest and specific communication. “First, we try to calm the nerves of the technicians, especially if they are newer to the audit process,” he says. “We let them know it is 100% acceptable for them to answer an assessors question with ‘I don’t know’, as long as it is followed with insight on where they would go to find the answer. We also train our technicians to answer the question asked, but not to volunteer more information than requested.”

Bring It All Together

For laboratories that are in the early stages of accreditation, or considering becoming accredited, the following expert advice can be key to a successful outcome:

In Part II of this article, we will explore 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.

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