LABS Show Their Credentials
What Does It Mean to Be Accredited by AIHA-LAP, LLC?
By Joe Unangst
The competitive intensity in the industrial hygiene testing market seems to have increased over the past few years. More than 90 percent of customers at risk for poor air quality use a third-party laboratory to test their results. The key for customers, both consultants and end users, is to look for an accredited industrial hygiene lab. But what does being accredited mean?
Accredited laboratories have worked diligently to attain this status. To obtain accreditation through the AIHA® Laboratory Accreditation Programs (LAP), a lab has to provide extensive documentation as part of its application and undergo a comprehensive review of its operations. The lab must provide AIHA-LAP with proof of compliance to a long list of requirements related to its facility, employees, instrumentation, procedures and quality system. The road to accreditation begins with an electronic application. Applicants must also respond to questions related to the submission.
The 35-page application requests the following information:
- General information about the company.
- The scope of analyses the laboratory is requesting.
- The methods the lab proposes to use and its proficiency testing plan. The methods must be acceptable to AIHA-LAP.
- A management summary and information about all of the management and technical staff. All technical staff must meet minimum qualifications.
- A description of the lab's instrumentation. The lab must have adequate space, facilities and instrumentation for the services provided.
- Documentation for each program to prove the lab has all of the necessary procedures and qualifications for accreditation.
- A certification of regulatory compliance, AIHA-LAP indemnification, and an affidavit to confirm purchase of the ISO/IEC 17025:2005 standard.
New laboratories seeking accreditation will not proceed through the process until all of the paperwork shows compliance with all of the requirements. AIHA-LAP has continuously streamlined this process over the years. However, the application for a lab that performs analysis in multiple programs with multiple fields of testing with multiple types of analytical instruments may be several hundred pages. Completing the application process is not simple, and getting all of the procedures, training, documentation and proficiencies in order takes hard work.
Quality and Validity
Accredited labs have systems and processes in place to ensure quality and validity. The largest part of a lab's quality system is its documentation of procedures, forms, training, quality control and software calculations.
As you might imagine, a lab can have hundreds of procedures, from simple to complex. The lab's standard operating procedures (SOPs) are the basis for the AIHA-LAP analysis. The SOPs must be clear and concise to ensure that analysis of samples is consistent. These procedures can be called into court as evidence of conformance to an approved method. The lab even needs an SOP for writing SOPs! Once the lab has a fully documented step-by-step procedure, it must be validated to prove the lab can produce accurate and precise data down to a limit of quantitation (LOQ) that is proven to be reachable. Validation of the method requires demonstrated LOQs, desorption efficiency determination (where applicable), spike recovery and duplicate studies. The lab must document and store all of these validation requirements to prove the systems and processes were in place and capable of producing the reported result.
Once the procedures are in place, the lab must ensure that the chemist analyzing the samples is fully trained in the procedure. The training must be documented and the knowledge obtained in the training verified through a test. In other words, the lab must develop a training program for each field of testing and a written test for every training program to ensure competency. To verify that each chemist is trained in the same manner, AIHA-LAP requires training manuals in each field of testing. The proof of complete training comes from each chemist performing the analysis using a specific method and demonstrating competency through accurate results, which is known as proficiency testing. Each analyst must demonstrate proficiency several times each year to comply with AIHA-LAP requirements.
On top of this, every form used in the lab is required to be an approved form, with proper document control, to eliminate non-approved changes or the use of an outdated form. Any spreadsheet or computer program used to calculate data is required to be tested and validated against hand calculations of the same formulas. This is required to be done at least annually and any time a program is modified in any way.
An accredited lab has demonstrated it can analyze blind samples with accuracy. Before a lab enters AIHA-LAP, it is required to participate successfully in an approved proficiency testing (PT) program for all categories of analyses that are part of the lab's services. The lab must demonstrate successive rounds of accurate results on these blind samples to be considered for accreditation, whether the lab is applying for a new accreditation or renewing an existing accreditation.
Conformance to Standards
An accredited lab has been audited for conformance to standards and documented operating procedures for several methods. Once the lab has proven it can analyze blind proficiency samples for successive rounds and has answered any questions about its application to the satisfaction of the AIHA-LAP reviewer, a site visit is scheduled. The site assessor performs a physical audit over a two- to five-day period, depending on the number of programs, categories and fields of testing for which the lab is seeking accreditation. This site assessment is used to verify the written application and to discover any deficiencies or findings that need to be corrected prior to accreditation. The on-site assessor can also include suggestions for improvement, which makes the on-site visit an excellent tool the lab can use to enhance its programs.
Site assessments are conducted by trained, experienced assessors contracted by AIHA-LAP. These assessments generally take place every two years unless additional site assessments are deemed necessary by the AIHA-LAP Analytical Accreditation Board (AAB). Site assessors review randomly selected documents to ensure that all requirements are being followed. They track the path of actual samples through the lab to ensure all procedures are being followed as written, that trained analysts are performing the work, and that the reporting on selected samples is correct.
Site assessors question the analyst, supervisor, quality assurance officer and director to determine whether their knowledge and experience is sufficient to analyze the samples with accuracy and precision, and that the management and controls are in place to consistently produce quality analyses. Using a checklist, the site assessor reviews a complete set of processes, procedures, systems, people, instruments and facilities to show that the lab can perform to the requirements of the ISO/IEC 17025:2005 standard. Any deficiencies uncovered by the site assessor require the lab to take corrective action and provide proof of conformance. In some cases the site assessor may require another on-site visit to verify a deficiency has been corrected.
With all deficiencies corrected, the site assessor may recommend accreditation. The AAB votes on acceptance of the lab for accreditation.
AIHA-LAP policies require the lab's executive management to commit to data integrity. The importance of data integrity must be clear to everyone in the company. All of the documented processes and procedures, quality assurance systems and controls in the world cannot always detect a rogue employee. Data integrity training is an absolute requirement for ISO/IEC 17025:2005 accreditation. Such training explains the potential issues, makes clear that every employee is required to strictly adhere to the standard, and spells out the legal consequences compromising data integrity. Every employee is required to sign a statement of understanding after being tested on their knowledge.
Accredited labs have ISO/IEC 17025:2005 recognition with the rest of the world through AIHA-LAP, which is a full member of the International Laboratory Accreditation Cooperation (ILAC) and a signatory of the ILAC Mutual Recognition Arrangement (MRA). ILAC is an international cooperation of laboratory and inspection accreditation bodies formed to help remove technical barriers to trade. Only accreditation bodies that have been evaluated by ILAC peers and deemed competent and equivalent can enter into the ILAC MRA. The ultimate aim of the ILAC MRA is the increased use and acceptance by industry and regulators of the results from accredited labs and inspection bodies, including results from labs in other countries.
AIHA-LAP is also a full member of the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and a signatory of the APLAC Mutual Recognition Arrangement. That means AIHA-LAP accreditation is accepted all over the world.
Finding a Lab
What should you look for in an AIHA-accredited lab? Here's a list to get you started:
- Commitment to a set of principles that the ownership, management, and associates demonstrate through their interactions with you and the services they provide.
- Open, frequent communication from the lab and avenues for you to provide feedback on the lab's services.
- Excellent references who know the people and history of the lab. (You should also get to personally know the people in the lab you are using.)
- A commitment to integrity demonstrated through the lab's adherence to standards no matter the circumstance and willingness to make right any issues you may have.
- Real, continuous improvement with preventive and corrective action plans. Openness to your suggestions for improvement.
- Staff that is genuinely helpful, friendly, and responsive. This usually reflects the care with which your samples are being tested.
Seeking out an AIHA-accredited lab is not difficult. AIHA-LAP offers several ways to find such a lab. Interested persons can visit www.aihaaccreditedlabs.org/Pages/ListofAccreditedLab.aspx or call AIHA-LAP at +1 (703) 846-0736.
Joe Unangst is president and CEO of Galson Laboratories. He can be reached at firstname.lastname@example.org or 1 (888) 432-LABS.
Standard of Testing Competence
The ISO/IEC 17025:2005 standard, "General Requirements for the Competence of Testing and Calibration Laboratories," covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
ISO, the International Organization for Standardization, is the world's largest developer and publisher of international standards. IEC, the International Electrotechnical Commission, publishes international standards for all electrical, electronic and related techniques.