D02.94.01 - Task Group A: Quality Assurance and Quality Control

SIGNIFICANCE AND USE
5.1 All ASTM standard test methods are required to include statements on precision and bias. To obtain such data it is necessary to conduct an interlaboratory study. This document is designed to provide a brief overview of the steps necessary in an ILS and to suggest an appropriate sequence in carrying out these steps.  
5.1.1 Qualitative tests such as Test Method D130 copper corrosion may not require an ILS.
SCOPE
1.1 This guide describes the procedures for planning and conducting an interlaboratory study (ILS) of a test method used in Petroleum Products and Lubricants Committee D02 of ASTM for the purpose of estimating repeatability and reproducibility of the test method in accordance with ASTM Form and Style requirements.  
1.2 This guide is concerned with the management of the ILS and intended to provide guidance for the planning stage and ensure the process, logistics, and tools are identified and agreed upon in advance.  
1.2.1 Selection of the samples and the impact of sample selection on the final scope of the test method—both the range of materials covered in the scope and precision sections and the measurement range covered in the precision section—are important, and careful consideration needs to be given to these aspects before an ILS is launched.  
1.3 This guide does not concern itself with the development of test methods but rather with gathering the information needed for a test method precision statement.  
1.4 This guide is concerned with test methods which yield a single numerical figure as the test result, although the single figure may be the result of a calculation from a set of measurements.  
1.5 This guide is designed for tests of properties that are stable, such that bulk samples can be homogenized and sub-samples can be prepared that will be identical and stable for the duration of the ILS testing period. This guide is not designed for unstable properties or for properties that make it difficult to obtain stable, representative samples for an ILS conducted at multiple laboratory sites.  
1.6 This guide represents the suggested practices for a typical precision study. Individual subcommittees may modify this approach as their expertise directs.  
1.7 This guide is voluntary, and thus, is not required for an approved precision study.

SIGNIFICANCE AND USE
This guide can be used to evaluate the performance of a laboratory with regards to its adherence to established laboratory quality practices for the essential elements of managing a well-performing laboratory. The suggested scoring system can be used to identify the laboratory areas which need improvement in performance.
The assessment guide (Table 1) should be adjusted or modified to reflect the specific laboratory quality system that the laboratory follows. This guide is based on Practice D6792.
5.3 Similar but more generic schemes can be found in other ASTM standards such as Guide E548, E882, E994, and E1323. But this guide is the first one to attempt a numerical evaluation for the petroleum products and lubricants testing laboratories in the oil industry.
TABLE 1 Laboratory Assessment Guide to Good Laboratory Practices
Note 1—When the sampling is within the control of the laboratory, documents other than quoted above may detail the sampling process (not only ASTM). For example, company procedures. These should be assessed as well to check compliance to industry standards and then to ensure the laboratory complies with these procedures.
Note 2—Samples, when received by the laboratory from customers, should question the integrity of the sample and make some reference on the final test report to the fact that tests were completed on samples as received. If sample container was not appropriate, a similar caveat should be included. Instruction/procedure on how to deal with these situations should be documented and the laboratory assessed against it.
Note 3—In-house instructions/operating procedures also need to be assessed where used/written for each test method.   NumberIssueCommentMaximum Score 1.0 PERSONNEL & TRAINING 1.1 Is there an organization chart available for the lab? / 5 1.2 Is there a management approved policy, directive, endorsement or the like for the goals and operations of the laboratory? / 10 1.3 Are job descriptions provided for all lab...
SCOPE
1.1 This guide covers and provides direction for the self-assessment of the quality system practices in a laboratory testing petroleum products and lubricants in the oil industry. This guide is intended to satisfy requirements of international laboratory quality standards to conduct periodic self-assessments. It is not intended for comparing laboratory performance among a laboratory group or for use in external certification programs.
1.2 Other forms of assessment formats may also be acceptable as long as they cover the essential elements of this guide regarding laboratory capability.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
WITHDRAWN RATIONALE
This guide covers and provides direction for the self-assessment of the quality system practices in a laboratory testing petroleum products and lubricants in the oil industry. This guide is intended to satisfy requirements of international laboratory quality standards to conduct periodic self-assessments. It is not intended for comparing laboratory performance among a laboratory group or for use in external certification programs.
Formerly under the jurisdiction of Committee D02 on Petroleum Products, Liquid Fuels, and Lubricants, this guide was withdrawn in October 2017 and replaced by Practice D6792 for Quality Management Systems in Petroleum Products, Liquid Fuels, and Lubricants Testing Laboratories.1