A LABORTORY NETWORK PERSPECTIVE
ON NELAC ACCEDITATION & RECIPROCITY
BY STL PITTSBURGH
Patrick A. Conlon
QA Manager & Technical Director
STL Pittsburgh
450 William Pitt Way
Pittsburgh, PA 15238
Severn Trent Labortories
STL is a Laboratory Network comprising 29 labs from with certifications covering all 50 states plus Puerto Rico. As a Network of laboratories we have a natural interest in the development of uniform standards for laboratory accredition.
STL: Interested in NELAC from the Laboratory Network Perspective
In forming a network of labs, there have been competing forces that have an impact on the management of quality systems. For example there is the interest on one hand in looking, acting and performing as if we are one company, or at least a “network” of labs united on a common basis of standards, goals and commitments. On the other hand individual labs faced with local state and program requirements frequently insist upon having substantial latitude to deal with local requirements, whether they be state, program or client specific requirements. STL has viewed the development of NELAC with both hope and enthusiasm, because of the promise of the development of a more comprehensive and consistent set of “consensus standards” for quality systems.
Consensus Standards as the Foundation for Reciprocity
NELAC Policy and Structure
1.1.1Overview of NELAC
The purpose of the organization is to foster the generation of environmental laboratory data of known and documented quality in a cost-effective manner through the development of nationally accepted standards for environmental laboratory accreditation.
1.4.1Purpose
NELAC shall be a standards-setting body. NELAC shall, through the process described in the constitutions and bylaws, develop, adopt and publish uniform consensus performance standards on which the national accreditation program shall be based …including…..Quality systems, proficiency testing, audit programs,and other key elements.
I am going to focus on the issue of “Consensus Standards” because from my point of view:
a)It is at the heart of reciprocity or recognition among state programs.
b)It implies a higher level of “comparability” among state programs than previously existed and therefore presents both opportunity and challenge for NELAC
c)It is a central issue to the management of a lab “network”; therefore STL has a keen interest in it.
d)The principle of consensus has a powerful legal and quality element and therefore reinforces the defensibility of both systems and data.
In short the issues of consensus standards and reciprocity are directly related.
Practical Considerations in Dealing with Multiplicity
In order to highlight the potential impact of program requirements on the Environmental Laboratories, I would like to describe in comparison three hypothetical labs in how they have accommodated external performance requirements:
Lab A: Is found to have numerous QAPPs and SOPs that vary for differing state, programs and clients specific requirements. If a client or program auditor asks for something unique or special in the form of QA requirements, this lab will customize a product that satisfies this request. From a QA point of view this is okay. However from an operations point of view, complexity of product lines increases communications, training and reliability problems and ultimately does have and impact on quality of product. From a common sense point of view, the key elements of quality systems and procedures should not be subject to significant variantion.
Lab B: In an effort to keep things simple lab B has used the accumulation approach to QA. Over the years the lab has taken individual requests from numerous auditors and has layered them to a product line and QC program that satisfies all standards. An auditor can look at this lab and say “great”, “more is better”, “you’ve exceeded requirements” and miss the fact that the lab may have lost touch with the source methods and objective external standards of performance or they may have chosen to ignore them. In this lab, the analyst may be well versed in the lab procedures, but not be familiar with actual method requirements. In performing to a higher standard a lab can actually do the client a disservice by not meeting other needs. Examples: not meeting turn around, inaccurate narration of deficiencies and/or repeating analysis when not required. Because or this, in many cases, exceeding QA program requirement has little, if any, value to overall quality.
Lab C: Lab C uses an approach where they establish SOPs and a QA program that satisfies a majority of method and program requirements. And sets up a menu of customized extras, when necessary, that the lab can implement when needed. In this last case, the Lab is efficient and effective at meeting program and client requirements. It also has a QA program that is easier to monitor and administer, however its effectiveness is limited by the extent to which there is consensus in the analytical community as to what elements are important and how they should be executed within specific programs. Overall both quality management and operations management benefit with the implementation of “cost effective”, “nationally accepted” “uniform concensus performance standards”.
Comparability: Challenges to NELAC and to the Expansion of Program
1)Comparability of Lab Assessments does not currently exist
a)Resources devoted to single assessments
i)NELAC Audits have been observed to take from 1 person for 1.5 days up to 4 persons for 5 days.
b)Latitude of interpretation excercised during audits
i)Are all audits equivalent? Not yet. States and even individual auditors have been found to have significant inconsistencies from lab to lab.
ii)Inconsistencies have included fundamental interpretation inconsistencies.
iii)This is a special problem states have never really had to police their auditors in the past and it is certainly not in the role of the laboratories to do it.
c)How much discretion in these matter should be allowed? That will remain a tough question for a while.
d)Auditors will need to be trained to comply with the standards and be monitored for their own adherence.
In the end, if labortories, clients and/or regulatory agencies do not perceive NELAC Accreditation Authorities and their auditors as being comparable, than there is more to do. This comparability is essential to NELAC meeting its objectives of “cost effective”, “nationally accepted” “uniform concensus performance standards”. This comparability is essential to NELAP being a success.
2)Comparability of Accreditation Scope and FOT
a)There is no provisions within NELAC that currently requires these to be equivalent from state to state.
b)However, to the extent that the scope of accreditation differ among the states interstate accredited labs have:
i)Significant increase in level of complexity and cost, requiring multiple accrediting authorities and mixed certification lists to get full accreditation.
ii)A reason for preference in choosing accrediting authorities.
And new states entering the program may be put off by the confusion of the complexity of accreditation.
Conclusion:
A system of Consensus Standards upon which Reciprocity is base should result in a program that is:
1)Dedicated to quality.
2)Achieves a balance of quality, effectiveness and cost concerns.
3)Achieves a high level of comparability among the accrediting authorities in both practice and principle.
4)Promotes growth of the NELAC program and use of the NELAC standards because of they are (or at least will be) reasonable, workable and defensible and readily acceptable.
In considering the struggles of NELAC in developing consensus standards amidst completing ideas, I am reminded of a comment that Ben Franklin made upon signing the Constitution. Paraphrasing here, he stated that while many thought that the constitution was not at all a perfect document, He so liked the good points of it and the building of consensus was of such great value that he admitted he “was not sure if a better document could be achieved”. It is hoped that on the same foundation, that of nationally accepted practical consensus principles, NELAC may also flourish.