Tag Archives: ISO 17025

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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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.

Laboratory Information Management System

How LIMS Facilitates ISO 17025 Certification in Food Testing Labs

By Dr. Christine Paszko
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Laboratory Information Management System

In order to ensure that a food testing laboratory maintains a quality management system that effectively manages all aspects of laboratory operations that affect quality, there are numerous records, reports and data that must be recorded, documented and managed.

Gathering, organizing and controlling all the data that is generated, managed and stored by food testing laboratories can be challenging to say the least. As the ISO Standards and regulatory requirements for food testing laboratories evolve, so does the need for improved quality data management systems. Historical systems that were very efficient and effective 10 years ago, may no longer meet the demanding requirements for ISO 17025 certification. One way to meet the challenge is to turn to automated solutions that eliminate many of the mundane tasks that utilize valuable resources.

There are many reasons for laboratories to seek this certification, including to enhance reputation, gain a competitive advantage, reduce operational costs, and meet regulatory compliance goals. A major advantage for food testing laboratories to obtain ISO 17025 Certification is that is tells prospective clients that the laboratory has a strong commitment to quality, and they hold the certification to prove it. This certification not only boosts a laboratory’s reputation, but it also demonstrates an organization’s commitment to quality, operational efficiency and management practices. Proof of ISO 17025 Certification eliminates the need for independent supplier audits, because the quality, capability and expertise of the laboratory have been verified by external auditors. Many ISO Certified laboratories will only buy products (raw materials, supplies and software) and services from other ISO-certified firms so that they do not need to do additional work in qualifying the vendor or the products.

There are many areas in which a LIMS supports and promotes ISO 17025 compliance. Laboratories are required to manage and maintain SOPs (standard operating procedures) that accurately reflect all phases of current laboratory activities such as assessing data integrity, taking corrective actions, handling customer complaints, managing all test methods, and managing all documents pertaining to quality. In addition, all contact with clients and their testing instructions should be recorded and kept with the job/project documentation for access by the staff performing the tests/calibrations. With a computerized LIMS, laboratory staff can scan in all paper forms that arrive with the samples (special instructions, chain of custody (CoC), or any other documentation). This can be linked to the work order and is easy assessable by anyone who has  the appropriate permissions. The LIMS provides extensive options for tracking and maintaining all correspondence, the ability to attach electronic files, scanned documents, create locked PDFs of final reports, COAs (Certificate of Analysis), and CoCs.

Sample Handling and Acceptance

Laboratories are required to have a procedure that defines all processes that a sample is subjected to while in the possession of the laboratory. Some of these procedures will relate to sample preservation, holding time requirements, and the type of container in which the sample is collected or stored. Other information that must be tracked includes sample identification and receipt procedures, along with acceptance or rejection criteria at log-in. Sample log-in begins and defines the entire analysis and disposal process, therefore it is important that all sample storage, tracking and shipping receipts as well as sample transmittal forms (CoC) are stored, managed and maintained throughout the sample’s analysis to final disposal. To summarize, the laboratory should have written procedures around the following related to sample preservation:

  • Preservation
  • Sample identification
  • Sample acceptance conditions
  • Holding timesShipping informationStorage
  • Results and Reporting
  • Disposal

The LIMS must allow capture and tracking of data throughout the sample’s active lifetime. In addition, laboratories are also required to document, manage and maintain essential information associated with the analytical analysis, such as incubator and refrigerator temperature charts, and instrument run files/logs. Also important is capturing data from any log books, which would include the unique sample identifier, and the date and time of the analysis, along with if the holding time is 72 hours or less or when time critical steps are included in the analysis, such as sample preparations, extractions, or incubations. Capturing the temperature data can be automated such that the data can be directly imported into the LIMS. If there is an issue with the temperature falling outside of a range, an email can automatically be spawned or a message sent to a cell phone to alert the responsible party. Automation saves time and money, and can prevent many potential problems via the LIMS ability to import and act on real-time data.

If any instrumentation is used in the analysis, the following information must also be recorded in the instrument identification (to ensure that it is in calibration, and all maintenance and calibration records are current), operating conditions/parameters, analysis type, any calculations, and analyst identification. In addition to analyst identification, laboratories must also keep track of analyst training as it relates to their laboratory functions. For example, if an analyst has not been trained on a particular method or if their certification has expired, the LIMS will not allow them to enter any result into the LIMS for the method(s) that they have not been trained/certified to perform. The LIMS can also send automated alerts when the training is about to expire. Figure 1 shows a screen in the LIMS that manages training completed, scheduled, tests scores, and expiration dates of the training, along with the ability to attach any training certificates, exams, or any other relevant documentation. Laboratory managers can also leverage the LIMS to pull reports that compare analyst work quality via an audit report. If they determine that one analyst has a significant amount of samples that require auditing, they can then investigate if there is a possible training issue. Having immediate access to data allows managers to more rapidly identify and mitigate potential problems.

Laboratory Information Management System
LIMS manages a variety of aspects in training, including when it has been completed, scheduled, tests scores, and expiration dates. (Click to enlarge)

Another major area that a LIMS can provide significant benefit is around data integrity. There are four main elements of data integrity:

  1. Documentation in the quality management system that defines the data integrity procedure, which is approved (signed/dated) by senior management.
  2. Data integrity training for the entire laboratory. Ensures that the database is secure and locked and operates under referential integrity.
  3. Detailed, regular monitoring of data integrity. Includes reviewing the audit trail reports and analyzing logs for any suspicious behavior on the system.
  4. Signed data integrity documentation for all laboratory employees indicating that they have read and understand the processes and procedures that have been defined.

The LIMS will enhance the ability to track and manage data integrity training (along with all training). The LIMS will provide a definition of the training, the date, time, and topic (description); instructor(s); timeframe in which the training is relevant, reminders on when it needs to be repeated; along with  certifications, quiz scores, copies of quizzes, and more. With many tasks, the LIMS can provide managers with automated reports that are sent out at regular time intervals, schedule training for specific staff, provide them with automatic notification, schedule data integrity audits, and to facilitate FDA’s CFR 21 part 11 compliance (electronic signatures). The LIMS can also be configured to automatically have reports signed and delivered via fax or email, or to a web server. The LIMS manages permissions and privileges to all staff members that require access to specific data and have the ability to access that data, along with providing a secure document control mechanism.

Laboratories are also required to maintain SOPs that accurately reflect all phases of current laboratory operations such as assessing data integrity test methods, corrective actions and handling customer complaints. Most commercial LIMS provide the ability to link SOPs to the analytical methods such that analysts can pull down the SOP as they are doing the procedure to help ensure that no steps are omitted. Having the SOPs online ensures that everyone is using the same version of the locked SOPs, which are readily available and secure.

Administrative Records, Demonstration of Capability

Laboratories are required to manage and maintain the following information on an analyst working in the laboratory: Personal qualifications and experience and training records (degree certificates, CV’s), along with records of demonstration of capability for each analyst and a list of names (along with initials and signatures) for all staff that hold the responsibility to sign or initial any laboratory record. Most commercial LIMS will easily and securely track and manage all the required personnel records. Individuals responsible for signing off on laboratory records can be configured in the LIMS to not only document the assignment of responsibility but also to enforce it.

Reference Standards and Materials

Because the references and standards that laboratories use in their analytical measurements affect the correctness of the result, laboratories must have a system and procedures to manage and track the calibration of their reference standards. Documentation that calibration standards were calibrated by a body that can prove traceability must be provided. Although most standards are purchased from companies that specialize in the creation of reference standards, there are some standards that laboratories create internally that can also be traced and tracked in the LIMS. Most commercial LIMS will also allow for the creation, receipt, tracking, and management of all supplies in an inventory module, such that they document the reference material identification, lot numbers, expiration date, supplier, and vendor, and link the standard to all tests to which it was linked.

The ISO 17025 Standard identifies the high technical competence and management system requirements that guarantee your test results and calibrations are consistently accurate. The LIMS securely manages and maintains all the data that supports the Quality Management System.

Key advantages of food testing laboratories that have achieved ISO 17025 Certification with a computerized LIMS that securely and accurately stores all the pertinent data and information:

  • Proof of ISO 17025 Certification eliminates the need for supplier audits, because the quality, capability and expertise of the laboratory have been demonstrated by the certification.
  • Knowledge that there has been an evaluation of the staff, methods, instrumentation and equipment, calibration records and reporting to ensure test results are valid.
  • Verification of operational efficiency by external auditors that have validated the quality, capability and expertise of the laboratory.
  • Defines robust quality controls for the selection and authentication of methods, analyzing statistics, controlling and securing data.
  • Clearly defines each employee’s roles, responsibilities and accountability.
  • Confidence that the regulatory and safety requirements are effectively managed and met in a cost efficient-manner.