[A Closer Look at Labs] Testing the Lab

A critical component of food safety at any plant is testing of its product and environment. Because the vast majority of these tests are conducted for plants by contract laboratories, processors are placing a great deal of trust in and staking their reputations on the practices and processes of a third party.
While not the only way to appraise a contract lab, processors can look to third-party assessments, certifications and accreditations for validation of a laboratory’s quality system and practices.

With its network of the national standards institutes of 154 countries, global acceptance and cross-industry reputability, the International Organization for Standardization (ISO) is one of the most recognized systems. Its international standardization is achieved through mutual recognition arrangements (MRAs): concensus agreements between nations on specifications and criteria for material classification, manufacture and supply of products, testing and analysis,  terminology and service provision.

One world, one TEST. Roger Brauninger, senior laboratory services officer for the American Association for Laboratory Accreditation (A2LA), Frederick, Md., puts it this way:  MRAs reduce trade barriers — and costs — by promoting the concept of “one test that is accepted everywhere, one accreditation accepted worldwide.” A2LA is a nonprofit, non-governmental, membership organization that offers programs for laboratory accreditation based on ISO/IEC 17025:2005.

One example of international acceptability is that of nuts such as pistachios and almonds, grown primarily in California. Although samples are tested in American labs, if a grower wants to sell his nuts in, say, Ireland, he would need to have them retested there. But with the MRAs, the tests done in the U.S. by an accredited lab are accepted, “so it doesn’t cost the importer or exporter to test first in their own country then again where they are selling it,” Brauninger said.

PROCESSOR INTEREST. Although FDA does not require that a lab be accredited, as global trade continues to increase, both laboratories and the food industry itself are showing an increased interest in such internationally accepted laboratory accreditation, with some processors requiring the standards at the labs with which they work.

In addition, with the recent emphasis and consumer interest in nutritional and allergen labeling, A2LA expects the push to begin coming from consumers as well, as they become  more educated and don’t just accept label statements, but ask “Who does this testing? How do I know it’s right?”

Accreditation also can help a processor’s argument of due diligence should a court case arise. For example, if a product were found to have a pesticide residue and some of its ingredients had been sourced outside the U.S., the fact that the ingredient sample tests had been conducted by an accredited lab would give more credibility and provide a stronger argument in court.

While A2LA is an accrediting body interested in promoting its own services, its interest lies just as much in the big picture: promoting accreditation as a whole through any member of International Laboratory Accreditation Cooperation (ILAC). As Public Affairs Manager Phil Smith said, “As a member of the ILAC Marketing and Communications Committee, I wear the ILAC hat often.”

WHAT IS ACCREDITATION?  Basically, accreditation is  recognition of a lab’s competency to perform specific tests. Although its accreditation is based on ISO standards, laboratories accredited under A2LA must meet even higher standards, with requirements including documentation of and conformance to:

• ISO/IEC 17025
• specific technical requirements
• A2LA policies
• requirements of the specific tests/calibrations for which the laboratory is seeking accreditation
• proficiency testing requirements

And while the accreditation is based on standards, those standards do provide flexibility for application to in-house as well as contract laboratories and testing in all areas.

“The ISO standard is written with the flexibility that even small laboratories can achieve accreditation,” Brauninger said. “There’s more than one answer; there’s more than one way to meet requirements.”

INDEPENDENT ANALYSIS. Thus, the documentation of and conformance to requirements confers an independent third-party approval of a lab’s testing, practices and procedures, as well as an objective assessment of any deficiencies.

A2LA’s Smith has been an assessor for five years, and more than once he has visited a lab that believed itself to have a high quality system, but when assessed against the standards, was actually found to have “many deficiencies,” he said.

Smith suggests labs focus on:

• process control
• a corrective actions program
• consideration of measurement uncertainty
• document control
• a systems management point person
• a documented list of procedures
• traceability in purchasing
• qualification policies for suppliers, and an approved vendor list
• testing standards and validation
• customer communication
• subcontracting
• continuous improvement based on root cause analysis

“Most labs are good at the technical side of things. We don’t find the methods being performed incorrectly,” Brauninger said, adding that the problems are instead usually more ancillary, such as the validation of methods and software, traceability procedures, etc. But because very few lab managers are trained in Quality Systems Management (QSM), they often think that their system works when it really doesn’t. Thus, implementing a QSM that adheres to standards adds coherence to the lab’s activities and helps to create a scientific approach to technical management.

“It formalizes the approach that a good scientist would take anyway. A good scientist would consider these, but it may be stuck in the back of his brain,” he said.

INFORMATION AGE. Implementing the standards with regular and thorough documentation and assessment enables continuous improvement in the lab and helps reduce errors. Labs don’t repeat their mistakes, fewer tests need to be repeated, and when there are failures, the system sets parameters for finding out why, Brauninger said. “If taken to heart, the accreditation process actually allows them to save money through reduced repeated tests.”

While some may feel there is an over-emphasis on documentation, it enables a lab to track for trends — positive and negative. Too many labs do not look at trends, Smith said, but doing so allows the lab to know if things are “going south.” They can then implement a risk analysis tool to analyze potential issues — which tests are most likely to have problems,  or where calibration most often falls off — and focus on these higher risk areas. “Put your energies where the problem is,” Brauninger said.

Documentation also proves that the lab is doing what it says it does. A2LA puts a great deal of emphasis on proficiency testing of the labs with which it works. Not only must the labs participate in relevant and available proficiency testing, but corrective action for any failures must be put in place. “A2LA has made a very big effort in that,” Brauninger said. “In the food testing areas especially, since so many of the samples they ordinarily test are free of contamination, proficiency testing also provides the laboratory an opportunity to gain experience with positives in matrices they are likely to encounter.”

ISO INTERPRETATION. Medallion Laboratories Technical Manager John
Szpylka is a member and past chair of the AOAC International Analytical Laboratory Accreditation Criteria Committee (ALACC). He said that, because the ISO/IEC 17025 standard was written to apply to all testing and calibration laboratories, applying the standards to a specific lab can be a bit “fuzzy.”

So the committee took on the task of preparing guidelines when interpreting the 17025 standards to food chemistry, food microbiological and pharmaceutical testing laboratories. Its role is to provide an interpretation with detailed recommendations to aid in assessing the essential requirements for performing these types of analyses.

“Another advantage of 17025 is that it was written by an international committee. This is one of its main strengths; it is also one of its challenges,” Szpylka said. With so many different languages, it was a challenge to ensure that the language of the standard can be understood  clearly and interpreted reliably across countries and cultures.

TECHNO-SPEAK. One example of this challenge is the extensive use of acronyms in the field. “Scientists will speak using acronyms nonstop,” Szpylka said. “But if you’re on the outside looking in, it sounds like techno-speak.” Another example is use of the word “sample,” he said. A sample could be something taken directly from the field; it could be what was sent to the lab; or it could be the portion cut for lab testing. So the committee analyzed the verbiage to define each use of the word sample and clarify the jargon.

When a lab is deciding whether it needs to be accredited and what accreditation it should have, managers should look at their business for direction. “One question they should ask is ‘What will the accreditation give us from a business standpoint?’” Szpylka said. He recommends that a lab be careful about the areas it attempts to pursue. Some are very focused, such as attaining accreditation for testing a particular product in a particular state or country.

“If your business is within the same state or country, that’s a good accreditation to have. It gives you credibility. But if you export across borders, it may give you some credibility, but how much in the big scheme?” he said. “In this example, multiple accreditations may be needed or perhaps a single accreditation recognized on both sides of the border.”

On the other hand, he said, “Any type of accreditation, as long as it is recognized, will benefit in some way. It may help the lab improve by uncovering deficiencies, or show where it is doing well; either way it is always beneficial to learn more about your operation.”

But it is the big scheme of things where ISO 17025 reigns. With its required proficiency testing program, “it really demonstrates your competence especially since it compares your lab to others; that’s why I believe it is a requirement within 17025.” Being broad-based, it can be applied to any testing laboratory, and, as Szpylka said, “it is becoming the 800-pound gorilla.”

AT THE LAB. Accreditation is not a quick, simple or inexpensive event; it’s a process that takes a strong commitment from the lab. As explained by Szpylka, indirectly quoting a speaker at a recent AOAC symposium on accreditation: “Certification is like getting a driver’s license, you’re proving to someone that you know how to drive today. Accreditation is continually showing that you are a good driver.”

To become accredited, said Mansour Samadpour, owner of IEH Laboratories , Lake Forest Park, Wash., the laboratory has to be able to show that it has a quality system in place, be committed to it, and apply it throughout its processes. “It’s not just having something that looks nice. Everything you do has to have been validated,” he said.

The author is staff editor of QA magazine.

The A2LA File

The company
A2LA opened in 1978 to provide a comprehensive national system of laboratory accreditation. It chose non-profit, membership-society status to increase transparency and global acceptability.

Governed by a board of directors, A2LA obtains guidance for technical committees and all criteria documents are approved by its Criteria Council.
With standards based on ISO 17025, it is dedicated to the formal recognition of competent testing and calibration laboratories, inspection bodies, proficiency testing providers and reference material producers.

A2LA assessors

With a minimum of 10 years of laboratory experience in their field of testing/metrology, most of A2LA’s assessors average 20-25. “When we send in an assessor, they know where to look!” said Roger Brauninger, the nonprofit’s senior lab manager. “It’s sort of like those pigs sniffing for truffles, they have a very good idea where to find them.”

When assessors join A2LA their technical expertise is then augmented with training in quality system analysis and the risk-based approach.

Accreditation
Once a lab is assessed, results are sent to the accreditation council, which is made up of volunteer experts. The council issues a report and the lab may respond. Then, the council has two weeks to review the package and vote for or against accreditation of the lab. If accreditation is not passed, the council  gives  reason for refusal, which a lab can then appeal.