Tag Archives: A2LA

Stillwater Labs Accredited to ISO/IEC 17025

By Cannabis Industry Journal Staff
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The American Association for Laboratory Accreditation (A2LA) announced earlier this month the accreditation of Stillwater Laboratories, Inc. to ISO/IEC 17025. Based in Olney, Montana, Stillwater Labs is the first laboratory A2LA has accredited to the ISO 17025 standard in the state. 

According to a press release, Stillwater is also the first in the state to go through a dual assessment, a new program put in place Fall of 2018. Both ISO/IEC 17025 accreditation and Americans for Safe Access (ASA) Patient Focused Certification were obtained by the lab. Stillwater achieved the recently updated ISO 17025:2017 accreditation.

“Stillwater Labs is honored to achieve ISO/IEC 17025:2017 accreditation” says Dr. Ron Brost, laboratory director Stillwater. “Quality methods are the cornerstone of our operations, and accreditation through the A2LA has been a valuable developmental process. We used the opportunity to refine, clarify, and tune our systems in order to bring world-class analytics to our clients in Montana. We look forward to continuing to drive advanced technologies coupled with excellent customer service through ISO/IEC 17025 best practices.” 

Kentucky Gets Its First Accredited Cannabis Testing Lab

By Aaron G. Biros
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Fouser Environmental Services LTD, a laboratory based in Versailles, Kentucky, became the first cannabis testing laboratory accredited in the state last week, according to a press release. The American Association of Laboratory Accreditation (A2LA) announced the lab’s successful accreditation to ISO/IEC 17025:2017.

“We congratulate Fouser Environmental Services on becoming the first cannabis testing laboratory accredited in the state of Kentucky. Their completion of this milestone in such a timely manner through the A2LA accreditation process is a testament to their hard work and commitment to quality”, says Adam Gouker, A2LA General Manager. “A2LA realizes the vital role that accreditation plays in the cannabis industry to support compliance with regulatory requirements, and we are thrilled to see that our service has been adopted in a new state. We look forward to our continued relationship with Fouser Environmental Services in the provision of their accreditation needs.”

Fouser Environmental Services has been an environmental testing lab in Kentucky for more than 30 years. A statement by the lab in the press release says they want to support the hemp industry as it continues to grow in Kentucky. “It is our great honor to be the first A2LA ISO/IEC 17025:2017 accredited laboratory for cannabis testing in the Commonwealth as we continue to strive to perform accurate analysis and release reliable data to the growing hemp industry within Kentucky and throughout the country,” reads the press release.

First Lab Authorized for Cannabis Testing in North Dakota

By Aaron G. Biros
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According to a press release published on April 3, Keystone State Testing (doing business as Dakota State Testing) became the first laboratory authorized to test cannabis in North Dakota. The lab also obtained their ISO 17025 accreditation for cannabis testing from the American Association of Laboratory Accreditation (A2LA), which is another first achievement for cannabis testing in the state of North Dakota.

Dr. Kelly Greenland, chief science officer at Keystone State Testing, says the North Dakota Department of Health set a high standard for the cannabis lab testing industry in the state. “Keystone State Testing is once again proud to of this monumental achievement and critical milestone in the company’s history to have met the highest levels of standards set forth by both A2LA and the North Dakota Department of Health,” says Greenland. “Keystone chose A2LA as its Accreditation Body due to their reputation in the industry, their diverse clientele, and the quality of their assessors.  A2LA’s assessors have spent decades in their respective fields, which helps to ensure that Keystone is providing the best services possible to their clients, regulators and patients.”

Keystone State Testing’s ISO 17025 accreditation scope covers 11 testing methods at their facility in Fargo, North Dakota. Those methods include: Cannabinoid potency analysis, cannabinoid profile, moisture content, residual solvents, water activity, along with microbiological tests like total yeast and mold count, E. coli, Salmonella, total aerobic microbial count, among others.

A2LA Accredits GoodCat Analytical to ISO/IEC 17025

By Aaron G. Biros
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According to a press release published last week, the American Association of Laboratory Accreditation (A2LA) announced the accreditation of GoodCat Analytical, LLC, a cannabis testing laboratory based in Naples, Florida. This marks the first time that A2LA has accredited a cannabis testing lab in the state.

Adam Gouker, A2LA General Manager, says this is a momentous achievement for GoodCat Analytical. “A2LA is excited to expand our cannabis accreditation program into yet another state, promoting the value of independent third-party accreditation to support quality products in the industry,” says Gouker. “We congratulate GCA Laboratories in achieving this milestone for their organization and wish them all the best as they move forward with this new endeavor.”

According to Jimmy Dodsworth, chief science officer at GoodCat Analytical, they had to develop a lot of methods on their own. “I can’t say enough about each of our staff members efforts to develop and validate each analytical method,” says Dodsworth. “The level of quality for these internally developed tests is amazing considering we started from scratch.”

Raymond Keller, owner and president of GoodCat Analytical, says A2LA’s support was an incredibly valuable resource for them. “We also need to acknowledge the tremendous guidance and support from the A2LA staff,” says Keller. “There is no doubt that they had a hand in making our lab the impressive operation it is today and know they will continue to do so moving forward.”

Phenova Gets Accreditation For Cannabis Proficiency Testing

By Aaron G. Biros
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Phenova, Inc., a proficiency testing products and reference materials provider based in Golden, Colorado, works with labs and regulatory bodies to develop proficiency testing (PT) programs. According to a press release sent out by the American Association for Laboratory Accreditation (A2LA), Phenova is A2LA’s first ISO/IEC 17043 accredited PT provider for the cannabis marketplace.

According to Ty Garber, director of new business development for the cannabis and food and beverage markets at Phenova, they have been working with A2LA for over a decade in other industries, but the cannabis testing industry is a huge new market for them. “Our Cannabis Proficiency Testing products and services are experiencing high demand across North America and we are fortunate to offer our expertise in proficiency testing to client laboratories and regulatory agencies in their joint efforts to ensure cannabis product quality and safety,” says Garber. “By working with the laboratories and stakeholder agencies, we have been able to develop and operate Proficiency Testing Programs based on real marijuana matrices, especially where the matrix creates specific analytical challenges. This approach has proven to be very beneficial for everyone involved, and we are working diligently to expand these efforts.”

Trace McInturff, senior director of accreditation services at A2LA, says this could help fill a serious need for conformity assessments in accredited cannabis labs. “A2LA is excited to announce the expansion of Phenova’s existing ISO/IEC 17043 Proficiency Testing Provider scope of accreditation to become the first A2LA accredited Proficiency Testing Provider for cannabis,” says McInturff. “This milestone adds to the positive historical relationship between Phenova and A2LA that dates back to 2005 when A2LA implemented a new TNI SSAS program for Proficiency Testing Providers and A2LA performed one of the first assessments of its kind at Phenova.” McInturff also says that A2LA has been instrumental in establishing the initial ILAC Proficiency Testing Provider accreditation requirements which ultimately became the basis for ISO/IEC 17043.

In addition to the “real marijuana matrix PT programs” that Phenova offers in certain states and countries where legal, they also offer alternative PT standards for labs that have obtained or are working on obtaining ISO/IEC 17025 accreditation.

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Discussing Lab Accreditation: The New ISO 17025:2017 Standard

By Aaron G. Biros
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At this year’s Food Safety Consortium a couple weeks ago, the newly launched Cannabis Quality Track featured a number of panels and presentations that highlighted the many intersections between food safety and cannabis. One particular topic of interest was measuring the quality and safety of cannabis products through laboratory testing. At the event this year, representatives from the leading laboratory accreditation bodies in the country sat together on a panel titled Accreditation, Regulation & Certification: Cannabis Labs and Production.

Representatives from ANSI-ASQ National Accreditation Board (ANAB), the American Association for Laboratory Accreditation (A2LA) and Perry Johnson Laboratory Accreditation (PJLA) discussed the new ISO standard, common issues that labs encounter when getting accredited, the future of the cannabis lab industry and certifications for food safety and quality.FSC logo

The panelists included:

  • Tracy Szerszen, president/operations manager, PJLA
  • Natalia Larrimer, engagement and program development manager, ANAB
  • Lauren Maloney, food safety program accreditation manager, Perry Johnson Registrars Food Safety, Inc. (PJRFSI)
  • Chris Gunning, life sciences accreditation manager with A2LA
Tracy Szerszen
Tracy Szerszen, president/operations manager, PJLA

The new ISO 17025:2017 standard was a topic addressed pretty early in the panel. Tracy Szerszen introduced the topic with a recap of the 2005 standard. “With 17025, for those that are familiar with the older version, 2005, there are really two sections of the standard for that one,” says Szerszen. “The newer standard is a little bit different, but there is a quality management system review that we do and we look at the laboratory to ensure that they are testing appropriately based on what they applied for. So, for cannabis labs, they typically have the same scope in types of methods with respect to microbiology and chemistry, and we are making sure they are following the standard from a technical standpoint, meaning they have the right equipment, the appropriate personnel and also have a quality management system.”

Chris Gunning followed that up with a closer look at the changes coming to the new 2017 standard. “If you are familiar with the 2005 version, you know that a lot of the clauses started out with a ‘you shall have a policy and procedure for doing X,’” says Gunning. “One of the major changes to the 2017 version is it gives laboratories more latitude on whether they need to have a policy/procedure to do certain things.” Gunning says the 2017 version is much more of an outcome-based standard. “As far as assessing to it, it becomes a little harder from our side because we can’t say you have to have this quality manual or you have to have this procedure that were going to assess you to. We are more open to looking at the outcomes.”

Christopher Gunning, life sciences accreditation manager with A2LA
Christopher Gunning, life sciences accreditation manager with A2LA

The most interesting change to the ISO standard comes with addressing the idea of risk. “One of the newest concepts in this standard is risk and how you assess your risk to your organization how you assess risk of impartiality, how you assess your measurement uncertainty when you are creating decision rules,” says Gunning. “Those are the big concepts that have changed in the 2017 standard in that it is more outcome-based and introducing the concept of risk more.”

After discussing some of the broader changes coming to the 2017 version, the panelists began delving into some common pitfalls and issues labs face when trying to get accredited. “From our experience, in Michigan, the new standard was written into the regulations, but a lot of labs were already accredited to 2005,” says Szerszen. “So, we actually contacted the state and explained to them that they have three years to transition. And some states will say ‘too bad, we want the 2017 ISO,’ so some of the cannabis labs are asking us to quickly come back so they can get appropriate licensing in the state and do a transition audit quickly.” She says most states seem to be comfortable with the current transition period everyone has, but it certainly requires some discussion and explanation to get on the same page with state regulators. “November 29, 2020 is the deadline for moving to the new 2017 standard.”

In addition to state requirements like traceability and security on top of an ISO 17025 accreditation, labs can run into issues not typically encountered in other testing markets, as Gunning mentioned during the panel. “One of the hardest parts of getting accredited is the need for properly validated methods, for all the different matrices in samples,” says Gunning. “Some of the biggest hurdles for new labs getting assessed are validation and the availability of reference materials and proficiency testing samples that meet their state requirements.” Those are just a handful of hurdles that labs aren’t usually anticipating when getting accredited.

Natalia Larrimer, engagement and program development manager, ANAB

Another big topic that generated a lot of dialogue during the panel was the need for a national accreditation standard for cannabis testing labs, one that Natalia Larrimer is advocating for. “Many laboratories are operating facilities in more than one state and what they are facing is a different set of criteria for laboratory recognition in each state, says Larrimer. “One initiative that we would love to see more support for, is a set of uniform requirements nationally. ACIL is currently working on developing these type of requirements which would be in addition to the ISO/IEC 17025 standard and specific for cannabis industry…” Larrimer says she’d like to see these requirements recognized nationally to get labs on the same page across multiple states. “This includes requirements for things like security, traceability, proficiency testing, sampling and personnel competence. The industry would greatly benefit from a uniform cannabis testing program across the US, so that testing facilities in Oregon are operating to the same criteria as facilities in California or Colorado, etc.”

The panelists went into greater detail on issues facing the cannabis lab testing industry, but also delved into certifications for food safety and quality, an important new development as the infused products market grows tremendously. Stay tuned for more highlights from this panel and other talks from the Food Safety Consortium. We will be following up this article with another that’ll shed some light on food safety certifications. Stay tuned for more!

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Lab Accreditation Bodies To Meet At Food Safety Consortium

By Aaron G. Biros
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The Food Safety Consortium, taking place November 13-15 in Schaumburg, Illinois, will host a series of talks geared towards the cannabis industry this year. The newly launched Cannabis Quality Track features a number of panels and presentations designed to highlight the many intersections between food safety and cannabis.

FSC logoThe track will have presentations discussing food safety planning in cannabis manufacturing, HACCP, GMPs, regulatory compliance and supply chain issues among other areas. One particular topic of interest in the quality and safety of cannabis products is laboratory testing. At the event this year, leading laboratory accreditation bodies in the country will sit together on a panel titled Accreditation, Regulation & Certification: Cannabis Labs and Production.

Roger Muse, vice president at ANAB

Representatives from ANSI-ASQ National Accreditation Board (ANAB), the American Association for Laboratory Accreditation (A2LA) and Perry Johnson Laboratory Accreditation (PJLA) will host the panel on the morning of Wednesday, November 14.

Panelists will include:

  • Roger Muse, vice president of business development of ANAB
  • Christopher Gunning, life sciences accreditation manager with A2LA
  • Tracy Szerszen, president/operations manager, PJLA
  • Lauren Maloney, food safety program accreditation manager, Perry Johnson Registrars Food Safety, Inc. (PJRFSI)
Tracy Szerszen
Tracy Szerszen, president/operations manager, PJLA

Laboratories that are new to the industry and looking to get accredited should be aware of the new ISO/IEC 17025:2017 standard, which was released last year. According to Tracy Szerszen, labs that have already been accredited to the 2005 version will be required to transition to the 2017 version by November 29, 2020. “This can be done in conjunction with routine assessments scheduled in 2019 and 2020,” says Szerszen. “However, laboratories are cautioned to transition within a reasonable timeframe to avoid their 17025: 2005 certificate from lapsing prior to the transition deadline. Some of the changes to the standard include but are not limited to: the re-alignment of clauses similar to ISO 9001:2015 and other ISO industry standards, modifications to reporting and decision rules, the addition of risked based thinking and a new approach to managing complaints.” Szerszen, along with the other panelists, will go much more in-depth on changes to the new ISO 17025 and other topics during the panel at the Food Safety Consortium.

Some of the other topics the panel will discuss include:

  • ISO/IEC 17025 –what’s expected, benefits of accreditation, common deficiencies, updates to the new 17025 standard
  • Standards available for production facilities-GMPs & GFSI standards
  • How standards can be used to safeguard the quality of production and safety requirements
  • An open discussion with panelists from leading accreditation bodies on the state of cannabis lab testing
Christopher Gunning, life sciences accreditation manager with A2LA
Christopher Gunning, life sciences accreditation manager with A2LA

According to Chris Gunning, many states are requiring accreditation to ISO/IEC 17025, the standard used throughout the world in many other high-profile industries such as the testing of food and pharmaceuticals, environmental testing, and biosafety testing. “In an industry where there are few standard methods, where one hears that you can ‘pay to play,’ and where there are ‘novice’ laboratories popping up with little experience in operating a testing laboratory, it is extremely important to have an experienced, independent, 3rd party accrediting body evaluating the laboratory,” says Gunning. “This process confirms their adherence to appropriate quality management system standards, standard methods or their own internally developed methods, and can verify that those methods produce valid results. Ultimately, the process of accreditation gives the public confidence that a testing laboratory is meeting their state’s requirements and therefore consumers have access to a quality product.” He says most states with legal cannabis recognize the need for product testing by a credentialed laboratory.

Lauren Maloney, food safety program accreditation manager, Perry Johnson Registrars Food Safety, Inc. (PJRFSI)

Another important topic that the panel will address is the role of food safety standards in the cannabis industry. Lauren Maloney says cannabis product manufacturers should consider GMP and HACCP certifications for their businesses. “Food safety is important to the cannabis industry because although individual states have mandated several food safety requirements there still considerable risks involved in the production of cannabis products,” says Lauren Maloney. “Consumers want the assurance that the cannabis products are safe and therefore should be treated like a food product. Because FDA does not have oversight of these production facilities, third party certification is essential to ensure these facilities implement a robust food safety system.”

The panelists will examine these issues along with other topics in greater detail during their talk at this year’s Food Safety Consortium.

A2LA Partners With ATACH

By Aaron G. Biros
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Last week, the American Association for Laboratory Accreditation (A2LA) and the American Trade Association for Cannabis and Hemp (ATACH) announced a new partnership agreement. This partnership is the first of its kind where a laboratory accreditation body and a cannabis trade organization work together under an MOU.

According to the press release, the two organizations hope to promote “foundational standards for quality control testing and regulatory guidelines that promote product safety.” Both organizations will advocate for the adoption of industry standards they deem appropriate for recreational and medical cannabis as well as hemp testing in the United States.

Michael Bronstein, executive director of ATACH, says there is an urgent need for open-source consensus standards and standard test methods for cannabis testing. “In an industry that lacks standard test methods and where testing is such a crucial part of the regulatory landscape, the need for open-source consensus standards is especially significant,” says Bronstein. “The development and adoption of standard test methods for cannabis testing is essential in ensuring consistency between laboratories, encouraging uniformity in state testing regulation, and providing a safe and consistent product to consumers.”

The press release also states that A2LA and ATACH seek to “develop regulation and adopt industry standards with goals of advancing and professionalizing the industry.”

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EVIO Labs Massachusetts Accredited to ISO 17025

By Aaron G. Biros
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EVIO Inc.’s Massachusetts lab announced yesterday they received ISO/IEC 17025 accreditation from the American Association for Laboratory Accreditation (A2LA). According to the Massachusetts Cannabis Control Commission, the body in charge of regulating the state’s cannabis industry, accreditation to ISO/IEC 17025: 2017 is a requirement for cannabis testing labs.

The press release says this makes EVIO Labs Massachusetts one of only a few operating and accredited testing laboratories serving the state’s medical cannabis industry. With recreational sales coming shortly to the state, EVIO is preparing for a higher demand in their lab testing services. “We are very proud of all of the teams’ hard work that resulted in this advanced accreditation,” says James Kocis, lab director of EVIO Labs Massachusetts. “With the state-mandated laboratory regulations, EVIO upholds the high standards of testing and plays a pivotal role in ensuring consumer safety and confidence in the states burgeoning marijuana market.”

According to Adam Gouker, general manager at A2LA, EVIO Labs Massachusetts, based in Southborough, MA, is the first cannabis laboratory they accredited in the state. “A2LA is excited to expand our cannabis accreditation program into yet another state, promoting the value of independent third-party accreditation to support quality products in the industry,” says Gouker. “Having the opportunity to work with a prominent name in the industry such as EVIO Labs and assess their exceptional Massachusetts laboratory has been an additional bonus.”

EVIO LogoAccording to the A2LA press release, by achieving ISO/IEC 17025 accreditation, EVIO Labs Massachusetts demonstrates that they “have management, quality and technical systems in place to ensure accurate and reliable analyses, as well as proper administrative processes to ensure that all aspects related to the sample, the analysis, and the reporting are standardized, measured, and monitored.” It also requires that personnel are competent to perform each analysis.

EVIO Inc. operates in the cannabis testing market with lab services in a number of states, including Oregon, California and Florida among others. Their Florida location was the first accredited cannabis lab in the state and they recently earned the same accreditation for their Berkeley, California location.

Dr. Ed Askew
From The Lab

Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary

By Dr. Edward F. Askew
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Dr. Ed Askew

Editor’s Note: The views expressed in this article are the author’s opinions based on his experience working in the laboratory industry. This is an opinion piece in a series of articles designed to highlight the potential problems that clients may run into with labs. 


This article is the first in a series that will look into the risks any user of laboratory services (growers, processors or dispensary owners) will face from the quality systems in place in the laboratory. I will discuss specific risk areas in clear and understandable language so as to not obscure the substance of the article series with abbreviations and nomenclature that is not familiar with the reader. Subjects of the articles that follow will focus on the specific laboratory certification or accreditation requirements and how the user may find out if their risks are addressed. As these articles are meant to be interactive with the reader, users are encouraged to send questions or suggested topics to the author.

This article will be an introduction to the typical laboratory process that generates the “paperwork wall” and how it might impact the user.My experience with laboratory certification or accreditation (difference between the two discussed later in this article) comes from over 30+ years in the environmental chemistry field. My experiences include working under the Clean Water Act, Safe Drinking Water Act, FIFRA (pesticides) and ISO 17025 laboratory analyses and laboratory management. I have also received training to perform ISO 17025 and EPA Drinking Water audits. During this time I have been audited as a laboratory analyst/laboratory manager and have performed audits.

As such, I can open up the laboratory structure beyond the sterile “paperwork wall” that has been constructed to allow the user to see the quality of data that is used in final reports that can wreak havoc. This article will be an introduction to the typical laboratory process that generates the “paperwork wall” and how it might impact the user.

One of the common misconceptions that a user has with a “certified or accredited” laboratory is that procession of a certificate indicates that ALL laboratory analyses produced are accurate and precise. I liken this to the “paperwork wall” that laboratories produce when the user questions any results reported to them. The laboratory management assumes that they have answered the user complaint (i.e. a certified/accredited laboratory cannot make a mistake) and the user will not pursue further questions once the certificate is produced.Accreditation does not guarantee that the laboratory personnel can perform the analyses the user is paying for; just that the laboratory’s paperwork has been audited.

First off, let’s look at what the difference between the terms certified laboratory vs. accredited laboratory. These simple words mean specifically different types of laboratories. According to the NIST National Voluntary Laboratory Accreditation Program (NVLAP):

  • Certification is used for verifying that personnel have adequate credentials to practice certain disciplines, as well as for verifying that products meet certain requirements.
  • Accreditation is used to verify that laboratories have an appropriate quality management system and can properly perform certain test methods (e.g., ANSI, ASTM, and ISO test methods) and calibration parameters according to their scopes of accreditation.

So, how does that impact the user?

  • If your state or 3rd party certificate only accredits a laboratory, then the accreditation agency only inspects the laboratory’s quality program as it applies to written documents and static equipment. (e.g. The quality manual is written and the standard operating procedures (SOPs) are in place).
  • Accreditation does not guarantee that the laboratory personnel can perform the analyses the user is paying for; just that the laboratory’s paperwork has been audited.
  • Certification on the other hand says that the laboratory personnel are qualified to perform the laboratory analyses and that the final laboratory results meet specific (certain) requirements. In other words, the laboratory’s quality plan and SOPs are met.

There are three different paths that are utilized by state cannabis control agencies to accredit or certify a cannabis laboratory.

  • ISO 17025: The ISO laboratory quality standard for laboratory accreditation is the most broadly used. ISO 17025 is an international standard and its implementation in the United States is regulated by ILAC. There are three 3rd party companies that audit for and award ISO 17025 accreditation certificates. They are Perry Johnson Laboratory Accreditation Inc., ANAB and A2LA.
  • TNI: The NELAC Institute standards are utilized by one state to handle their cannabis laboratory accreditation.
  • States: Some states have tried to blend an ISO 17025 requirement with their own state’s certification requirements to produce a mixed accreditation-certification program. But, this type of program may rely on two or more agencies (e.g. ISO 17025 3rd party auditors communicating with state auditors) to cover all specific laboratory areas.

PJLAIn two of the paths above, the final result is that the laboratory receives accreditation. That means that only the quality management system and the scope (e.g. SOPS, laboratory instruments, etc.) have been audited, not the laboratory personnel or their capabilities. The third pathway may produce a certified laboratory or may not.

To provide an example of where an accredited laboratory followed their paperwork but produced inadequate results:

  • I received a laboratory report for organic chemical analyses of a client’s process.
    • The laboratory results placed the user in noncompliance with the state and federal regulatory limits.
    • But, the laboratory result contained data flags (e.g. additional information that explains why the laboratory result failed the laboratory’s quality requirements).
    • The laboratory still received payment from the user as the laboratory performed the analyses.
  • I had to explain to the regulatory agency that some of the data flags when investigated showed:
    • The laboratory failed to use the approved analytical method.
    • The detection level for the regulatory chemical was so low that the laboratory had no instrument capable to see those chemicals at the concentrations reported by the laboratory.
  • The state regulators accepted the explanation I provided and the user was no longer under a regulatory administrative order.
  • But, when I presented this information to the accreditation agency that accredited this laboratory I was informed:
    • The laboratory flagged the data so it can be reported to the user.
    • If the user wanted more from the laboratory, then the user will have to outline their specific requirement in a quality contract with the laboratory. (i.e. If the laboratory identifies the problems then they can report the data no matter what happens to the user).

So now, what is being done behind the “paperwork wall”? Areas such as those listed below can impact the results received by the user.

  • Laboratory quality culture: What does the laboratory staff think about quality in their normal daily work?
  • Laboratory staff competence: What is the level of training and real world competence of the staff that actually works on the analyses?
  • Laboratory capabilities: Does the laboratory actually have the laboratory instruments and equipment that can perform the analyses the user needs?
  • Laboratory quality control parameters: What is in the quality manual and does it make sense?
  • Laboratory analytical method validation: Are the analytical methods used by the laboratory validated by approved statistical procedures?

What should the user have in place to limit their risks from laboratory analyses?

  • Failsafe sampling preparation plans: Make sure the user samples for the laboratory are collected correctly.
  • Failsafe’s on laboratory sample reports: Protect the user from bad laboratory reports.
  • User auditing of the laboratory: Go to the laboratory and see if the laboratory can pass muster.

What’s Next: The next article will go behind the laboratory “paperwork wall” to detail the culture that impacts the user results negatively and how that can be recognized. Follow-up articles will help users developing quality plans that identify risks and how to limit them.