Tag Archives: root cause

Audit

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

By Joy Dell’Aringa
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Audit

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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Ryan Gooley, Mock Recalls

Practice, Practice, Practice. Why Mock Recalls Are So Important

By Maria Fontanazza
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Ryan Gooley, Mock Recalls

Being recall ready goes beyond checking off the boxes for meeting traceability requirements, qualification standards, or meeting auditing requirements for certifications. “It’s really a discussion that needs to happen from a business continuity standpoint within an organization so that should there be an issue, the team has actually talked through different strategies and ways of technically executing a recall within the organization,” says Ryan Gooley, recall consultant at Stericycle ExpertSolutions. During an interactive workshop at next week’s Food Safety Consortium conference, Gooley will lead attendees through recall scenarios and help them create a recall plan to address global needs, communications strategies, resource allocation, and business continuity requirements. Gooley recently sat down with Food Safety Tech to discuss the importance of mock recalls within the food industry.

Food Safety Tech: What are the most common mistakes food companies make in preparing (or not preparing) for a recall?

Ryan Gooley: One of the mistakes companies make is not having the discussion internally about a recall and whether they are ready and able to respond to and support a recall. Although it’s becoming less of an issue, people still don’t want to talk about recalls—they’re afraid if they talk about it, it will happen to them.

They also take their industry partners, whether supply chain partners or existing vendors, for granted.

Ryan Gooley is leading a session, The Multiplier Effect: How One Ingredient Can Lead to Multiple Recalls, at the 2016  Food Safety Consortium conference  on Thursday, December 8 | Learn More In addition, companies miss the amount of effort and resources it takes to properly support a recall once a communication goes out. This specifically relates to class I or class II recalls that go down to the consumer level and involve press releases and media exposure.

In any industry, your resources are geared toward producing product and getting it into the market; it’s not the reverse of managing take-backs and returns, and communicating to customers. A lot of it comes down to resource allocation.

FST: What are the most important elements of a recall plan in the food industry?

Gooley: Traceability is huge. Most companies have a pretty good understanding of traceability as it relates to where they receive ingredients, where the ingredients go within their processes, and ultimately where they are distributed. Traceability is important, because you can’t initiate a recall if you cannot identify where the suspect product went.

The other part of the recall plan is testing the plan. Going through your recall plan and testing it pulls together the different departments that are responsible for supporting the recall exercise and effort within the company. Having conversations about who is responsible for what, the information [that should be] pulled, and who needs that information is really important for building the team. [It ensures that] should a company need to initiate a recall, the team members who are engaged and responsible have actually talked through the process and practiced. With more practice comes more efficiency and less chance for error or oversights.

Another important element of a recall plan is understanding your communication plan and communication crisis management plan. A lot of people talk about recalls as just identifying the product and notifying downstream what to stop selling, etc., but a lot of what goes into the recall plan is business strategy—how are you going to manage not only retailer and customer calls, but consumer calls and media calls? Who is responsible for communicating what, when and where? Do you notify just your impacted customer or do you notify your non-impacted customers? What type of communication and messaging do you have? When companies have not done a mock recall exercise, oftentimes they have not had these conversations, and they really struggle on the communications piece, especially because it needs to be drafted, approved, and communicated in a very short period of time.