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.
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| Number | Issue | Comment | Maximum 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 laboratory associates? | | / 5 |
| 1.4 | Are personnel qualification records including training maintained for all lab personnel? | | / 5 |
| 1.5 | Are technicians trained in all pertinent tests? | | / 10 |
| 1.6 | Are newly hired technicians trained by approved trainers? | | / 10 |
| 1.7 | Before new technicians perform routine analysis, are they evaluated to produce correct results by analyzing quality control standards? | | / 10 |
| 1.8 | Are technicians provided instrument training courses where necessary? | | / 10 |
| 1.9 | Are there back-up technicians for each test? | | / 5 |
| 1.10 | Is there a documented system for training and is it being followed? | | / 5 |
| 1.11 | Is there a system to recognize innovative ideas from technicians? | | / 5 |
| 1.12 | Are there quality improvement teams organized in the lab? | | / 5 |
| 1.13 | Are results of these teams’ work readily available? | | / 5 |
| 1.14 | Does management review the work of these quality teams? | | / 5 |
| | TOTAL | /195 |
| 2.0 SAMPLE PREPARATION | | |
| 2.1A | Has a representative sample been obtained per Practice D4057 or D4177 protocols? | | / 5 |
| 2.2B | If the sample analysis involves LPG, does the sampling and storage follow instructions in Practice D6849? | | / 5 |
| 2.3B | Are LPG samples obtained according to Practice D3700 if using a floating piston cylinder? | | / 5 |
| 2.4B | Are LPG samples collected using manual method Practice D1265? | | / 5 |
| 2.5B | For the analysis of calcined petroleum coke, is Practice D6969 followed for sample preparation? | | / 5 |
| 2.6B | For collection of calcined petroleum coke, is Practice D6970 followed? | | / 5 |
| 2.7B | For ampulization and storage of gasoline is Practice D6596 being followed? | | / 5 |
| 2.8B | If volatility measurements are conducted on fuel samples, is Practice D5842 being followed? | | / 5 |
| 2.9B | Is Practice D4296 being followed in sampling of pitch? | | / 5 |
| 2.10B | Are aviation fuel samples stored in containers suitable according to Practice D4306 | | / 5 |
| 2.11B | Are gas turbine fuels handled in accordance with Practice D4418? | | / 5 |
| 2.12B | If in-service monitoring of fluids is done, is Practice D4378 being followed? | | / 5 |
| 2.13 | Are appropriate sample containers being used, checked for their integrity, cleanliness, and compatibility? | | / 5 |
| 2.14B | Is liquid sample mixing done using Practice D5854 protocol? | | / 5 |
| | TOTAL | / 175 |
| 3.0 TEST METHOD COMPLIANCE | | |
| 3.1 | Are all test methods used in the lab available to all staff members? | | / 10 |
| 3.2 | Is a current site specific lab manual available? | | / 10 |
| 3.3 | Are the methods specified in the product specifications used for analysis? | | / 10 |
| 3.4 | Are all tests performed in the lab following the exact language of the written test methods? | | / 30 |
| 3.5C | Has the lab modified any of the specified test methods? | | ? |
| 3.6 | If so, has it been shown that the modified method gives results equivalent to those obtained by the specified method? | | / 20 |
| 3.7 | If a method is modified, is the customer informed about this change? | | / 5 |
| 3.8 | Are all tests specified in the product specifications performed? | | / 10 |
| 3.9 | If not, has approval been given in writing by the process leaders and/or customers not to carry out all tests? | | / 5 |
| 3.10 | Does the lab have appropriate instrument for the analysis? | | / 10 |
| 3.11 | Is an equipment inventory list available and is it up-to-date? | | / 5 |
| 3.12 | Are major instruments included in service contracts? | | / 5 |
| 3.13 | If not, has arrangement been made to get the instrument speedily repaired or use of a back-up lab for analysis? | | / 5 |
| 3.14 | Are logs kept of all downtime and service problems of all instruments? | | / 5 |
| 3.15 | Is there a system of backup in case of instrument failure? | | / 5 |
| 3.16 | Is there a long range plan of upgrading and replacing older instrumentation? | | / 5 |
| 3.17 | Has a maintenance schedule been established for all equipment in the lab? | | / 10 |
| 3.18 | Is a record of special or routine or preventive maintenance kept and is it up-to-date? | | / 5 |
| 3.19 | If a duplicate analysis is done for some reason, are the results checked to see that they meet Practice D3244 or ISO 4259 criteria for replicate testing? | | / 10 |
| 3.20 | In reporting the results, are protocols given in Practice E29 and standards followed regarding rounding of the test results? | | / 10 |
| | TOTAL | / 175 |
| 4.0 CALIBRATION OF INSTRUMENTS | | |
| 4.1 | Are all pertinent calibration standards available in the lab? | | / 10 |
| 4.2 | Are they all stored in clean, safe, and contamination-free environment? | | / 10 |
| 4.3B | Is Practice D4307 followed for preparing liquid blends for use as analytical standards? | | / 5 |
| 4.4B | Is Practice D4051 used for the preparation of low-pressure gas blends? | | / 5 |
| 4.5 | Are the calibration standards traceable to national or international standards? | | / 5 |
| 4.6 | Where appropriate, are the values for reference materials produced by following the appropriate NIST or other standards issuing body certification protocol? | | / 10 |
| 4.7B | If used, are crude oil samples for mercury analysis handled as per Practice D7482? | | / 5 |
| 4.8 | Is relevant calibration done on all instruments before sample analysis? | | / 10 |
| 4.9 | Has a calibration schedule been established for lab equipment? | | / 5 |
| 4.10 | Are calibration procedures documented and available to all lab personnel? | | / 10 |
| 4.11 | If the calibration is done through a vendor, is it checked that it meets the requirements? | | / 10 |
| 4.12 | Are all calibration records maintained containing all necessary information? | | / 10 |
| 4.13 | When found to be out of calibration, is the instrument taken out of operation until the problem is fixed? | | / 10 |
| 4.14B | Was the performance of process stream analyzer, if used, validated using Practice D3764 or D6122, whichever is applicable? | | / 5 |
| 4.15B | If used, are moisture analyzers calibrated per Practice D4178? | | / 5 |
| 4.16B | If analyzers are used has a linear correlation been established between the analyzer and primary ASTM test methods using Guide D7235? | | / 15 |
| 4.17B | If metals are analyzed using ICP-AES, is Practice D7260 followed for ICP-AES operation? | | / 10 |
| 4.18B | If metals are analyzed using XRF, is Practice D7343 followed for XRF operation? | | / 10 |
| 4.19B | If balances are used for analytical purposes, are they being calibrated using Test Method E898? | | / 10 |
| 4.20B | If thermometric measuring devices are being used, are they calibrated using Test Method E77? | | / 10 |
| 4.21B | If timers are used for measurement purposes, are they being calibrated or verified using the relevant standard test method? | | / 10 |
| | TOTAL | / 180 |
| 5.0 STATISTICAL QUALITY CONTROL | | |
| 5.1 | Is a QC program set up for each routine test performed in the lab, if pertinent? | | / 10 |
| 5.2 | Has a schedule of QC frequency been established and followed? | | / 10 |
| 5.3 | What is the frequency of QC testing? | | / 10 |
| 5.4D | Is a QC samples analyzed with each “batch” of samples? | | / 10 |
| 5.5 | Is a list available showing tests with QC program, standards, frequency, and the analyst responsible for running it? | | / 10 |
| 5.6 | Are control charts used in the lab for all appropriate tests? | | / 10 |
| 5.7 | Are the control charts being plotted in real time? | | / 10 |
| 5.8E | Are the control charts plotted manually or electronically? | | / 5 |
| 5.9F | Are the control charts plotted by technicians or supervisors? | | / 10 |
| 5.10G | Are the control charts displayed near the test stations or filed in cabinets? | | / 5 |
| 5.11 | Are all relevant data recorded on the QC charts (e.g., analyst name or initial, date, numerical value, etc.)? | | / 10 |
| 5.12 | Are the values reported on the control chart consistent with the reporting resolution in the test method? | | / 5 |
| 5.13 | Are the mean ± standard deviation values assigned to the QC sample based on at least 20 replicate measurements? | | /10 |
| 5.14 | If starting the chart with 15 or less data points, is it revised after obtaining 20 -30 data points? (D6299) | | /10 |
| 5.15H | How many statistical run rules are used for control charts? | | / 10 |
| 5.16 | Have any run rules been violated? | | / 10 |
| 5.17 | What action was taken in such cases? Is the action taken documented? | | / 0
1. 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.
Keywords
calibration; calibration standards; certificates of analysis; laboratory manual; proficiency testing; quality control; quality control charts; quality control standards; safety practices; sampling; significant figures; statistical quality control; test methods; test performance index; training; Z-score;
ICS Code
DOI: 10.1520/D7776-12
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