Look for New Forms, Policy Changes and Updated Guidance Documents in 2010
The purpose of this communication is to describe policy changes that AIHA-LAP, LLC will publish in the next several weeks to implement quickly, some as early as January 1, 2010. It is imperative that you carefully review this document and the policy changes once published as these changes will impact your laboratory.
Background: As you know, AIHA Laboratory Accreditation Programs, LLC has memberships in the International Laboratory Accreditation Cooperation (ILAC) and two ILAC regional bodies-the Inter-American Accreditation Cooperation (IAAC) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC). We are now seeking international recognition by regional bodies APLAC and IAAC as a way of gaining international recognition by ILAC. Last July, a team of evaluators from both APLAC and IAAC conducted an evaluation of our operations and witnessed six assessments of various laboratories. This process is very much like the site assessments that our laboratories undergo. To respond to the findings from the joint evaluation, we will make several policy and procedural changes (most of them approved by the AAB at its October meeting). You have already been notified about two changes that we agreed to implement - a change in our accreditation logo and changes in the AAB composition and governance.
The first 6 items listed below describe the additional changes that will be made to address the findings from this evaluation, while items 7 through 9 outline other policy and guidance changes you can expect.
1. AAB Voting Member Approval Form - Effective January 1, 2010
To address the evaluation team's concerns about impartiality in accreditation decision-making, the AAB approved the use of a new AAB Voting Member Approval Form in addition to changing the AAB governance. Beginning January 1, 2010, staff will provide this form to laboratories immediately following assessments so you can identify persons on the AAB you may not want to participate in the accreditation decision-making for your laboratory.
2. Measurement Uncertainty and Traceability - New Policy documents, training, and articles in early 2010
Policy documents are being developed (to replace our measurement uncertainty and traceability guidance documents) that will be more aligned with international requirements. These policy documents will be posted on the AIHA-LAP, LLC website by the end of the year. Webinars for laboratory customers will be held in early 2010 as well as training sessions for our site assessors the week of January 18. Newsletter articles will follow in 2010 to update and inform the laboratories.
3. More Methods to be Sampled During Assessments; Revised 2A/2B Form - Effective February 1, 2010
One of our nonconformities related to the low percentage of methods sampled at industrial hygiene laboratories (a problem we see at large-scale IH labs). Up to 600 test methods appear on some scopes-mostly in the GC or HPLC fields of testing. To increase the sampling percentage in these types of laboratories, the AAB approved changes to the 2A/2B form to reflect the use of new Fields of Testing (FoTs) defined as "Technology or Analysis Category." FoTs were further subdivided by "Detector type/Technology Subclass" as shown in the draft 2B FoT Subclass Table. See the current 2B Form for IHLAP for your reference.
Each method under an FoT represents identical or a very similar collection of analytical approaches, so that assessing one method within an FoT or detector type/technology subclass is representative of all methods within that FoT or subgroup/detector class.
Beginning February 1, the assessors will be required to witness one method for each type of HPLC detector. For HPLC, both the UV and fluorescence detectors commonly used will be included in the test method selection and review. The same approach will be taken for laboratories that perform a large number of GC methods. For the GC core, the site assessor will review one method for each type of detector (FID, ECD, PID, FPD, NPD etc.) Site assessors will utilize their professional judgment and experience to determine if additional test methods must be assessed.
Additional TAP Review
The results of assessments from laboratories with a large number of methods will automatically be reviewed by a Technical Advisory Panel (TAP) member to ensure that our processes are being maintained and a thorough review of the laboratory's methods has been conducted.
The new forms will be published at the end of the year and become effective February 1, 2010.
4. New Approach to FoT Additions - Policy Change to 3.9 and Revised 2A/2B Form, Both Effective February 1, 2010
The AAB also approved policy changes and revised forms to address the nonconformity related to FoT additions. Specifically, they approved revisions to Forms 2A Scope of Analyses and 2B Methods and PT Participation Plan for the FoT Additions. The accreditation application is being revised accordingly so that laboratories may add FoTs during the accreditation period when those FoTs they seek to add are within core scope categories for which they are already accredited. If a laboratory chooses to add an FoT/method to a core scope category for which they are not currently accredited, the application will be sent to the site assessor for review and determination if a site visit is necessary, before being sent to a TAP reviewer. Please review the revised instructions included on the Form 2A-2B draft - Scope of Analyses.
For FoT additions at the time of assessment, the laboratory must first give sufficient notice of adding a new FoT and then provide all required information with a minimum of 10 business days' notice, subject to agreement by the assessor.
5. Appeals Process - Policy Change to Module 5; Effective February 1, 2010
To address impartiality, a requirement was added for each Appeals Committee member to sign a Conflict of Interest/Confidentiality form. Also addressing impartiality, the individual responsible for appointing Appeals Committee members was changed from the AAB Chair to the AIHA Board Liaison, since this individual is not involved in accreditation decisions.
There was also a change to clarify that the Appeals Committee is made up of three people (not five).
6. Logos - Policy Change to Module 7; Effective February 1, 2010
Changes were made to require the laboratory ID number to be listed on the logo. In addition, there was clarification on the use of the logo on business cards (which indicates that the laboratory is AIHA-LAP, LLC accredited and complies with ISO/IEC 17025:2005, but does not imply any certification or registration).
7. Other Policy Changes - Effective February 1, 2010
Module 2C - Environmental Lead Laboratory Accreditation Program (ELLAP) Specific Additional Requirements
In 2C.7, all laboratory records shall be maintained for a period of at least five (5) years. The change was from ten (10) years, and is due to the expected implementation of LQSR 3 and harmonization with requirement for fixed site laboratories.
8. Administrative Policy Changes - Effective February 1, 2010
Module 2D - Environmental Microbiology Laboratory Accreditation Program (EMLAP) Specific Additional Requirements
In 2D.6.1.1, the Standard Methods for the Examination of Water and Wastewater, 20th Edition, APHA, 1998 was changed to the 21st Edition, 2005.
Module 6C - Proficiency Testing (PT) for Environmental Lead Laboratories
In 6C.2.1, all the references to AIHA-LP, LLC were changed to AIHA-PAT, LLC due to an error in the August 2009 policies.
9. TM Guidance updated - Effective January 1, 2010
Changes were made to the acceptable coursework to qualify as an EMLAP Technical Manager (TM). These changes were enacted since the coursework requirement as of 2009 was reduced to eight (8) credits. This change will be effective January 1, 2010. Courses initiated before January 1, 2010, that were previously on the list will be accepted if completed no later than December 31, 2010.
In summary, accredited laboratories can look for many policy and procedural changes, now and in the coming months, to address issues such as impartiality, traceability and measurement uncertainty, method sampling, and FoT additions. Refer to the AIHA-LAP, LLC website for updates and more information.