ASTM-D7776 › Standard Guide for Self-Assessment of Quality System Practices in Petroleum Products and Lubricant Testing Laboratories (Withdrawn 2017)

ASTM-D7776 - 2012 EDITION - SUPERSEDED
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Standard Guide for Self-Assessment of Quality System Practices in Petroleum Products and Lubricant Testing Laboratories (Withdrawn 2017)

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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.

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.


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
2.1^A	Has a representative sample been obtained per Practice D4057 or D4177 protocols?		/ 5
2.2^B	If the sample analysis involves LPG, does the sampling and storage follow instructions in Practice D6849?		/ 5
2.3^B	Are LPG samples obtained according to Practice D3700 if using a floating piston cylinder?		/ 5
2.4^B	Are LPG samples collected using manual method Practice D1265?		/ 5
2.5^B	For the analysis of calcined petroleum coke, is Practice D6969 followed for sample preparation?		/ 5
2.6^B	For collection of calcined petroleum coke, is Practice D6970 followed?		/ 5
2.7^B	For ampulization and storage of gasoline is Practice D6596 being followed?		/ 5
2.8^B	If volatility measurements are conducted on fuel samples, is Practice D5842 being followed?		/ 5
2.9^B	Is Practice D4296 being followed in sampling of pitch?		/ 5
2.10^B	Are aviation fuel samples stored in containers suitable according to Practice D4306		/ 5
2.11^B	Are gas turbine fuels handled in accordance with Practice D4418?		/ 5
2.12^B	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
2.14^B	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
3.5^C	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
4.3^B	Is Practice D4307 followed for preparing liquid blends for use as analytical standards?		/ 5
4.4^B	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
4.7^B	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
4.14^B	Was the performance of process stream analyzer, if used, validated using Practice D3764 or D6122, whichever is applicable?		/ 5
4.15^B	If used, are moisture analyzers calibrated per Practice D4178?		/ 5
4.16^B	If analyzers are used has a linear correlation been established between the analyzer and primary ASTM test methods using Guide D7235?		/ 15
4.17^B	If metals are analyzed using ICP-AES, is Practice D7260 followed for ICP-AES operation?		/ 10
4.18^B	If metals are analyzed using XRF, is Practice D7343 followed for XRF operation?		/ 10
4.19^B	If balances are used for analytical purposes, are they being calibrated using Test Method E898?		/ 10
4.20^B	If thermometric measuring devices are being used, are they calibrated using Test Method E77?		/ 10
4.21^B	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
5.4^D	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
5.8^E	Are the control charts plotted manually or electronically?		/ 5
5.9^F	Are the control charts plotted by technicians or supervisors?		/ 10
5.10^G	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
5.15^H	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 –10
5.18	If a QC data point is found to be out-ofcontrol, are the samples analyzed between the last good QC data point and the first bad data point reanalyzed?		/ 10
5.19	Are appropriate QC samples being used for specific tests and relevant to the matrices being analyzed?		/ 5
5.20	Are QC samples prepared from stable, homogenous and well-characterized materials similar to the samples being analyzed?		/ 5
5.21^I	Is the same material used both for calibration and QC?		/ 10
5.22	Is QC material available in sufficiently large quantities?		/ 10
5.23	Is a program in place to replace the depleting QC material with a new lot of material?		/ 10
5.24	Is action taken when the control chart displays an upset?		/ 10
5.25	Is the action taken noted on the control chart?		/ 10
5.26	Does it appear that the corrective action taken has improved the chart?		/ 5
5.27	Does every test have a control chart? -If not, why not?		/ 10
5.28	Are sigmas calculated and updated from the control chart data? (D6299)		/ 10
5.29	Are they equivalent or better than the ones quoted in the standard test methods?		/ 10
5.30	If TPIs calculated are below the expected level in the standard methods, is any action taken to improve this situation?		/ 10
5.31^J	Are the sample results reported to the customers if the QC analysis is found to be out of control?		/ 0 – 10
5.32	Does the laboratory use random and/or blind testing to evaluate the performance?		/ 5 – 0
5.33	Are procedures in place to revise or replace the QC charts with new ones? (Practice D6792)		/ 10
		TOTAL	/ 295
6.0 QUALITY MANAGEMENT PROCESS
6.1	Does the laboratory have or is it a part of site ISO 9000 registration?		/ 10
6.2	Does the laboratory have ISO 17025 accreditation?		/ 10
6.3	Does the laboratory have any other quality accreditation? Specify.		/ 10
6.4	Is there a specific quality manager (or other designation) overseeing the quality activities in the laboratory?		/ 10
6.5	Is there a written quality manual?		/ 10
6.6	Are all staff trained in the quality principles and manual?		/ 10
6.7	Is a sample Analysis schedule available?		/ 10
6.8	Are all test method files up-to-date with current version?		/ 10
6.9	Does the laboratory conduct periodic internal audits to check that the expected quality systems are working?		/ 20
6.10	Are audits of test methods conducted to confirm adherence to documented test methods?		/ 20
6.11	Are the results promptly documented and action, if necessary, taken to correct the deficiencies?		/ 10
6.12	If deficiencies are observed in external audits (e.g., ISO 9000), are prompt corrective actions taken and documented?		/ 20
6.13	Is there a procedure for following up on any customer complaints and documenting the results?		/ 10
6.14	Has the laboratory established continuous improvement goal and teams to implement them?		/ 10
6.15	Are the activity reports of such teams available showing continuous improvement?		/ 10
		TOTAL	/180
7.0 PARTICIPATION IN PROFICIENCY TESTING
7.1	Does the laboratory take part in pertinent round robins or crosschecks?		/ 10– 0
7.2	What is the frequency of the laboratory’s participation in such round robins?		?
7.3	How many outliers did the lab have in the last three proficiency test programs? - How many tests were found with consecutive outliers in them?		/0 –10
7.4	What corrective actions, if any, are taken to follow up on the unsatisfactory proficiency testing results?		/0 – 10
7.5	Does the lab participate in ASTM ILCP cross checks?		/ 0 – 10
7.6	Are the Z-scores assigned to lab results satisfactory?		/ 10
7.7^B	Does the lab take part in TMC surveillance panel analysis?		/ 0 – 10
7.8^B	If the lab takes part in TMC surveillance, how well was the lab rated by TMC? /		NA-10
		TOTAL	/ 70
8.0 INFORMATION MANAGEMENT SYSTEM
8.1	Are all samples submitted to lab logged in before the analysis?		/ 10
8.2	Does each submitted sample receive an unique identification number?		/ 5
8.3	Does the system produce backlog and turnaround time reports?		/ 5
8.4	Are all analyzed samples logged out?		/ 5
8.5	Are certificates of analysis printed out when the analysis is complete?		/ 5
8.6	Do all COAs have all necessary information (e.g., analyst name or initials, day/time, sample identification name or number, test method used, numerical or other results)?		/ 10
8.7	Does the system plot quality control charts?		/ 10
8.8	Does the system flag out-of-statistical control data?		/ 10
8.9	Are all staff members familiar with the IMS?		/ 10
8.10	Does the lab have a documented system for sample retention?		/ 5
8.11	Are all data (e.g., weights, volumes, dilutions, analyst, results, etc.) produced in the lab permanently recorded?		/ 10
8.12	Are all required records kept for required period of time?		/ 5
8.13	Is there a document control system established in the lab?		/ 5
8.14	If some analyses are done by subcontracting to another lab is this clearly indicated in the COA?		/ 5
8.15	Before using an outside lab for analysis, has it been audited for its suitability to do the analysis?		/ 5
8.16	Are all various records kept in a secure place with only authorized personnel being admitted therein?		/5
		TOTAL	/ 110
9.0 NON-CONFORMANCE AND CORRECTIVE ACTIONS
9.1	Does the lab have a documented procedure for corrective actions and non-conformances, including Corrective Action Report (CAR)? Were they documented? Approximate number of CARs per year?		/ 20
9.2	What items are addressed by the corrective action system?		/ 10
9.3	Are roles and responsibilities for initiation, investigation, root cause analysis, corrective action, review, and approval identified and documented?		/ 20
9.4	Is reviewer and/or approver separate from the initiator/investigator if possible?		/ 10
9.5	Is there a target date for CAR closure?		/ 10
9.6	Are CARs closed in a timely manner?		/ 10
9.7	Do CAR forms have all appropriate signatures?		/ 10
9.8	How does the lab tract status of active CARs?		/ 10
9.9	Activities that demonstrate review or continuous improvement.		/ 20
		TOTAL	/ 120
10.0 SAFETY PRACTICES
10.1	Are all lab personnel trained in safety and emergency procedures?
10.2	Do all personnel have and use personal protective equipment (e.g., safety glasses, lab coats, gloves, safety shoes, etc.)?
10.3	Are fire extinguishers, safety showers, eye washers working properly?
10.4	Is there a regularly scheduled safety inspection?
10.5	Are chemicals and solvents stored in proper safety cabinets?
10.6	Are hoods properly ventilated?
10.7	Are gas cylinders properly secured and safety valves inspected?
10.8	Are MSDS sheets or other safety information on chemicals in the lab readily available?
10.9	Are used chemicals and samples properly disposed off in accordance with government regulations?
10.10	Does the lab have a clean and neat appearance?
10.11	Does the lab environment meet regulations regarding temperature range, dust, noise, radiation, drafts, etc.?

^A In some organizations, the sampling activity may be outside the control of the laboratory unit. For some products these standards may not be applicable.

^B If these specific products are not analyzed in the lab, these questions do not apply.

^C If the lab has not modified any of the test methods, credit should be given for that. If the laboratory has modified test methods, questions 3.5 and 3.6 would be pertinent.

^D At least 5 % of the samples analyzed should be QCs. However, in each batch QC should accompany the samples.

^E This is an informational question. Either answer is satisfactory.

^F Control charts should be plotted by the person who performs the analysis.

^G It is preferable that the charts be displayed near the test station, if possible.

^H Ideally 4 to 5 run rules should be used. See Practice D6792 for details.

^I The same material should not be used for both calibration and QC.

^J The sample results should not be reported to the customers if QC is out of control.

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 Number Code 75.080 (Petroleum products in general); 75.100 (Lubricants, industrial oils and related products)

To find similar documents by ASTM Volume:

05.05 (Combustion Characteristics; Manufactured Carbon and Graphite Products; Catalysts)

To find similar documents by classification:

75.080 (Petroleum products in general)

75.100 (Lubricants, industrial oils and related products Including mineral oils, fluids for metal working and for temporary protection against corrosion Lubrication systems, see 21.260 Insulating oils, see 29.035.40)

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Document Number

ASTM-D7776-12

Revision Level

2012 EDITION

Status

Superseded

Modification Type

Replaced

Publication Date

Jan. 1, 2012

Document Type

Guide

Page Count

14 pages

Committee Number

D02.94.01

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