develop consensus standards for use by TNI's programs. This group has a support role in assisting other programs with activities such as guidance and standards interpretation.
fosters the generation of data of known and documented quality is through the National Environmental Laboratory Accreditation Program, or NELAP. The purpose of this program is to establish and implement a program for the accreditation of environmental laboratories.
is to establish and maintain a national PT program to support TNI’s National Environmental Laboratory Accreditation Program, and other activities.
Field Activities Program (NEFAP) Executive Committee is to establish and implement an accreditation program for field sampling and measurement organizations (FSMOs).
Audit Sample Program is to develop consensus standards for the manufacture and analysis of audit samples for source emission testing.
on a variety of topics of interest to the environmental measurement community. TNI also hosts two regularly scheduled meetings per year, typically in January and August. Both are a week long and involve open meetings of TNI committees as well as training courses and other special sessions.Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard
Question: 4.3.2.2(b) requires documents to be reviewed "periodically". I have interpreted this to mean that NELAC wants the documents reviewed but requires the lab to establish the frequency. NELAC further supports this position by specifically requiring data integrity procedure to be reviewed annually (4.2.8.1). However, some assessors with whom I work take the position that since 4.14.1 and 4.14.5 require labs to annually review "testing activities" and conduct audits on "all elements of the management system" that these are inferred or indirect requirements to annually review all procedures. Since 4.3.2.2(b) addresses the issue directly, I take the position that it prevails over any indirect or inferred interpretation of the standard. TNI Response: The internal audits must show compliance with the laboratories policies and procedures. This is a procedural review for compliance and suitability. The periodic review of SOPs is set by the lab and does require that technical management review current procedures. This can be done with internal method audits. If the AB finds issues that would indicate that periodically has been stretched too long, then the AB could impose a finding that would require the timeframe be shortened. Also, support procedures can be allowed to have longer periods between review, such as when changes are needed due to a change in laboratory practice.
MODULE 2: QUALITY SYSTEM GENERAL REQUIREMENTS
Section: 4.3.2
