NIST Handbook 143
State Weights and Measures Laboratories Program Handbook

4. Recognition Process

A flowchart depicting the recognition process is shown in Figure 1. Details of this process are provided in this section. An overview of the recognition process includes:

• an annual solicitation by OWM;
• technical review of submitted material (see list in Table 1);
• review of on-site assessment results;
• review of proficiency testing results; and
• issuance of a Certificate of Traceability, along with a scope of recognition, and a letter describing the laboratory quality system.

4.1 Request for Recognition and Fees

Each State legal metrology laboratory, plus Puerto Rico, the District of Columbia, the Virgin Islands, Los Angeles County, and the Grain Inspection and Packers and Stockyards Administration (GIPSA) Master Scale Depot may automatically renew its recognition; however, a Request for Recognition must be submitted each year that details the requested Scope of Recognition. An annual evaluation is conducted by OWM.

Responsibility for measurement accuracy and traceability as used in commerce is cooperatively shared by a number of Federal and State agencies. An excellent working partnership exists between the State legal metrology laboratories and NIST, OWM. The laboratories provide payment-in-kind through voluntary efforts for many of the activities needed to maintain the recognitionprocess in partnership with OWM. As a result of this partnership and shared responsibilities, no fees are charged to these laboratories for support of the recognition process.

4.2 Annual Solicitation

Material for recognition and the issuance of Certificates of Traceability is annually solicited by NIST via a detailed memorandum between August 1 and September 15.

4.2.1 Annual submission period

Laboratories are to submit the Request for Recognition, along with specifically requested items each year between October 1 and November 15. If a laboratory fails to submit material in a timely manner, there is a risk that the Certificate of Traceability will not be renewed by the expiration date of the previous certificate. Certificates expire December 31 each year (or every 2 years) and are renewed January 1. Material must be submitted each year for the certificate to remain in effect. Material submitted late will be processed as expeditiously as possible once it has been received by the NIST OWM.

4.2.2 Information to be submitted

The information to be submitted annually depends on the particular circumstances of each laboratory's recognition and will be detailed in the solicitation memorandum. Requested information is always related to specific criteria as described in this Handbook.

Generally, a Request for Recognition, a completed checklist, and all associated forms and charts must be submitted each time the laboratory's Certificate of Traceability is due to expire. A list of items is detailed in Table 1. If the Certificate of Traceability has lapsed, it is treated as a renewal.

4.3 On-site Assessments (Monitoring and Requested)

Since all laboratories were initially established with the technical support and guidance of the NIST OWM in the late 1960's or early 1970's and have been visited by OWM staff, all on-site assessments initiated by OWM are considered monitoring assessments. Essential monitoring assessments are conducted periodically, generally in conjunction with training or regional meetings. Additional on-site assessments may be requested by the laboratory and will be conducted as practically feasible.

The primary objectives of on-site assessments are to: 1) ensure that the laboratories maintain laboratory quality by complying with documented criteria and 2) assist the laboratories to improve their overall operations, facilities, equipment, standards, or staff to ensure adequate accuracy and traceability to meet State legal requirements. On-site assessments may be conducted by NIST staff or by contracted TEs.

Technical Experts will use checklists and all formal assessment reports will follow the same general format to ensure consistency from one laboratory assessment to another. Assessments generally take between 1 and 3 days and are conducted to minimize disruption of normal laboratory operations. Since most State laboratories operate with minimal staff, as much advance notice as possible of the assessment date is given for scheduling purposes.

All OWM records concerning a given laboratory are available to OWM staff, NVLAP staff (if laboratory has applied to NVLAP for formal accreditation), or an assigned TE for evaluation. These include quality manuals, training records, RMAP attendance records, results of internal audits, results of round robin or other proficiency tests, control charts, NIST calibration reports, reports of tests, and any previous correspondence with the laboratory. During the actual on-site assessment, the assessor verifies information contained in the files through meetings with management and laboratory staff, by examination of facility, equipment, standards, test reports, quality documents, and procedures, and by observation of procedures. The assessor need not be given any information which violates individual privacy such as salary, medical information, or performance reviews outside the scope of the recognition program.

4.3.1 NIST staff

On-site assessments of the laboratories may or may not be conducted by NIST OWM staff. However, NIST staff will prepare all final laboratory assessment reports and communicate assessment results to the management and staff of each laboratory.

4.3.2 Technical experts

TEs (may also be called regional assessors) are metrologists with technical expertise plus appropriate auditing training and skills and discretion who have been selected to conduct on-site assessments for the State Laboratory Program. Criteria for selection are based on professional and academic achievement and are maintained in the NIST Office of Weights and Measures.

OWM strives to ensure fairness and impartiality in its assessments. TEs are required to sign a form regarding laboratory confidentiality. Concerns regarding any TEs should be brought to OWM's attention in writing. Records are maintained for the assessments each TE has conducted. NIST may provide additional training in auditing techniques for regional assessors. TEs may draft assessment reports; however, these reports will be reviewed and finalized by OWM staff.

4.3.3 Assessment report and invitation to respond

Either a draft assessment report or the assessor's notes may be left with laboratory staff or management at the close of a formal assessment. A formal assessment report may be issued to the laboratory detailing deficiencies and the expected preventive or corrective action. The laboratory is given an opportunity to respond or appeal stated deficiencies. An assessor may or may not be fully aware of specific laboratory conditions and clarification may be appropriate, thus the laboratory response may include additional clarification. The laboratory is expected to comply with deficiencies as soon as possible and to implement preventive action as a normal course of operations. The laboratory must submit a corrective action plan to OWM within 30 days of receiving a final report. This does not mean that deficiencies must be corrected within that time period; it only means that a plan for corrective action must be completed and submitted. OWM will respond to the laboratory regarding the acceptability of the laboratory response.

4.3.4 Contents of assessment report

The assessment report will contain, as a minimum, the following information:

1. name and address of the laboratory;
2. date of the assessment;
3. criteria used to conduct the assessment;
4. parameters and scope of recognition for the assessment;
5. name(s) of the assessors and affiliations;
6. name(s) of laboratory management and staff contacted during assessment;
7. list of additional records reviewed in addition to the on-site assessment (such as the quality manual, training records, control charts, or round robin results maintained by OWM);
8. references to the Program Handbook when deficiencies are identified;
9. recommendations and preventive action for laboratory improvement and discussion related to cited observations; and
10. deficiencies and corrective action required to meet program criteria and discussion related to cited observations.

4.4 Proficiency Testing

Interlaboratory comparisons (round robins) are conducted as a part of each regional measurement assurance program and constitute one of the primary methods used for assessment of competence. The other primary method is the assignment of Laboratory Auditing Program (LAP) problems upon the completion of each training seminar. However, on-site assessments may include demonstration of procedures, retest of a calibration item, or test of artifacts submitted directly to the laboratory.

Acceptable results of proficiency tests are essential for recognition to be granted; further investigation will be conducted to resolve any deficiencies. Proficiency testing results will be analyzed against accepted and/or standardized data analysis methods. As with on-site assessments and recognition decisions, the laboratory may contact OWM regarding proficiency testing results if they believe an analysis was incorrect or if insufficient information was available for a complete evaluation.

Proficiency testing deficiencies are defined as, but not limited to, one or more of the following:

1. failure to meet specified proficiency testing performance requirements or objectives prescribed at the outset of the round robin;
2. failure to participate in a regularly scheduled round of proficiency testing for which the laboratory has received instructions and/or materials;
3. failure to submit laboratory control data as required specific to each round robin;
4. performance as a statistically outlying laboratory in two successive rounds of proficiency testing or showing a general pattern of outlying results over three or more rounds; and
5. failure to produce acceptable calibration or test results when using special artifacts whose properties are well-characterized and known to NIST OWM.

4.5 NIST Technical Evaluation

Technical evaluation is conducted prior to awarding a Certificate of Traceability, and includes a full review of all available technical information regarding the laboratory. This may include annual submissions, control charts, quality manuals, assigned training problems, on-site assessment reports, results of proficiency tests, training records, attendance and participation at RMAPs, formal accreditation, plus any other relevant information affecting the quality of the laboratory's measurement results.

4.5.1 Review of submissions

Submissions will be reviewed and feedback provided to laboratories with the same level of significance as an on-site assessment. Preventive action will be recommended and corrective action will be required for noted deficiencies.

4.5.1.1 New, renewal, or expansion

Any laboratory that is to receive a new certificate for January 1 must submit laboratory material between October 1 and November 15. Material will be reviewed by OWM between November 15 and December 31.

4.5.1.2 Maintenance

If a laboratory has multi-year recognition, OWM will review material between November 15 and March 1 of the following year. In the event that material is not submitted during the appropriate time frame, OWM will review the material as time is available, giving preference to laboratories without current recognition.

4.6 Accreditation Periods and Policy

Selection of recognition periods is based on OWM judgment of the degree to which a laboratory meets criteria in this Handbook and whether the laboratory routinely submits data in a timely manner. While minor deficiencies may not affect a laboratory's ability to establish recognition, they will result in a shorter recognition period to encourage the necessary oversight to achieve corrective action.

Each laboratory will be given every opportunity to provide input to OWM for evaluation and to provide feedback to OWM assessments and evaluations. Any laboratory has the right to appeal recognition decisions in writing to the NIST Office of Weights and Measures.

Complaints regarding the operation of the recognition program, on-site assessments, document review by NIST or any NIST-assigned technical expert should be forwarded to the NIST OWM in writing.

4.6.1 Full renewal - 2 year

For those laboratories fully meeting criteria in this Handbook, a 2-year Certificate of Traceability will be issued; however, additional data must continue to be submitted annually for review as requested. Any laboratory that cannot meet the criteria in this Handbook should not apply for NVLAP formal accreditation.

4.6.2 One-year renewal

For laboratories where OWM management and oversight are required, or when minor deficiencies exist, a 1-year Certificate of Traceability may be issued based on the judgement of OWM staff that acceptable measurements will continue to be provided to laboratory customers.

NOTE: Until the new criteria in this handbook are fully met (including documentation), a laboratory will not be issued a 2-year Certificate of Traceability.

4.6.3 Conditional renewal

A 1-year conditional Certificate of Traceability may be granted when multiple deficiencies exist in the facilities, equipment, standards, staff, or overall laboratory operations, and the laboratory is working to meet criteria in this Handbook. Conditional recognition will only be issued to meet legal weights and measures requirements and limitations will be stated in writing. Conditional recognition will be marked on the certificate.

4.6.4 Maintenance

If a Certificate of Traceability for a laboratory has not expired, an annual review of submitted data and any laboratory on-site assessments may be conducted; however, no new certificate will be issued since the current certificate is valid.

4.6.5 Suspension, withdrawal, denial

In the event that circumstances change significantly during a recognition cycle, it is the responsibility of the laboratory to notify OWM. Any situation that critically affects the laboratory's ability to provide accurate and traceable measurements may be cause for temporary suspension of the Certificate of Traceability until criteria are met.

A laboratory may choose to withdraw from specific levels of recognition based on circumstances in the laboratory, but may be reinstated any time it fully meets criteria in this Handbook.

The result of an on-site assessment or of document review may include denial of recognition. Clear evidence of deficiencies will be provided to the laboratory in writing along with the required minimum corrective action. Denial of recognition may be modified based on the laboratory response or resolution of an appeal.

Table 1. Submission requirements for recognition