Model to Measure the Readiness of University Testing Laboratories to Fulfill ISO/IEC 17025 Requirements (A Case Study)
Abstract
:1. Introduction
2. Methods
2.1. Designing Laboratory Readiness Measurement Instrument
2.1.1. Generating Sets of Matching Criteria, Subcriteria, and Activities
2.1.2. Generating Sets of Indicators
2.2. Instrument Testing
3. Results
3.1. Laboratory Readiness Instrument Framework
3.2. Laboratory Readiness Level Measurement
4. Discussion
- IEC 62660-2, Secondary lithium-ion cells for the propulsion of electric road vehicles—contains two test parameters (i.e., reliability and abuse testing)
- ISO 12405-1, Road vehicles: Electrically propelled road vehicles—contains test specification for lithium-ion battery packs and systems in high-power applications
- ISO 12405-2, Road vehicles: Electrically propelled road vehicles—contains test specification for lithium-ion battery packs and systems and high-energy application that defines tests and related requirements for battery systems
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Criteria | Subcriteria | Activities | Process Element | Standard Item in ISO 17025 |
---|---|---|---|---|
Management (C1) | SC1-Planning | Formulate policies and objectives of the quality management system | Policies and procedures planning | 4.2 |
SC2-Organizing | Meet organizational requirements | Management responsibility | 4.1 | |
SC3-Staffing |
| Personnel management | 4.1, 5.1, 5.2 | |
SC4-Controlling |
| Complaint | 4.8 | |
| Nonconformity, corrective, and preventive actions | 4.9, 4.10, 4.11, 4.12 | ||
| Audits | 4.10, 4.14 | ||
| Management responsibility | 4.10, 4.15 | ||
Marketing (C2) | SC5-Service sales |
| Review requests, tenders, and contracts | 4.4 |
Marketing (C2) | SC6-Service planning |
| Customer service | 4.7 |
Operation (C3) | SC7-Resources |
| Testing | 5.8, 4.5, 5.10 |
| Purchasing | 4.6 | ||
| Infrastructure | 5.1, 5.3 | ||
| Method | 5.1, 5.4 | ||
| Equipment | 5.1, 5.5 | ||
SC8-Quality |
| External quality control | 5.1, 5.6, 5.9 | |
Operation (C3) | SC8-Quality |
| Internal quality control | 5.5, 5.6, 5.9 |
Management information system (C4) | SC9-Information system management |
| Information management | 4.3, 4.13, 5.4, 5.10 |
Subcriteria | Indicator |
---|---|
SC1-Planning | 1 Determination of management systems |
2 Application of management systems | |
3 Maintenance of management systems | |
4 Management policy documentation | |
5 Management system documentation | |
6 Program documentation | |
7 Documentation procedure | |
8 Documentation of work instructions | |
9 Communication of documentation to all personnel | |
10 Understanding of documentation by all personnel | |
11 Availability of documentation for all personnel | |
12 Application of documentation by all personnel | |
13 Quality manual | |
14 Quality objectives | |
15 Issuance of quality policy | |
SC1-Planning | 16 Laboratory management commitment |
17 Management statement for laboratory service standards | |
18 The objectives of management systems related to quality | |
19 Requirements for all personnel to understand and implement policies and procedures | |
20 Commitment to improve the effectiveness of management systems on an ongoing basis | |
SC2-Organizing | 1 Determination of organizational structure and laboratory management |
2 Determination of management position within the parent organization | |
3 Determination of the relationship between quality management, technical activities, and supporting services | |
4 Determination of responsibility, authority, and relations between all personnel | |
SC3-Staffing | 1 The presence of managerial and technical personnel |
2 Division of task management and technical personnel | |
3 Adequate supervision of testing staff | |
4 Technical management | |
5 Quality manager | |
6 Appointment of deputies for core management personnel | |
7 Educational qualifications | |
8 Training qualifications | |
9 Experience qualifications | |
10 Skill qualifications | |
11 Appropriate supervisors to staff undergoing training | |
12 Formulation of educational goals | |
13 Formulation of training objectives | |
14 Formulation of skill targets | |
15 Personnel training policies and procedures | |
16 Evaluate the effectiveness of training activities | |
17 The existence of contract/nonpermanent personnel | |
18 Maintenance of applicable job descriptions | |
19 Determination of authority to take samples | |
20 Determination of authority to conduct testing | |
21 Determination of authority to issue test reports | |
22 Determination of authority to give opinions and interpretation of test results | |
23 Determination of authority to operate certain equipment | |
24 Documentation of personnel authority | |
25 Documentation of personnel competence | |
SC3-Staffing | 26 Documentation of personnel education |
27 Professional qualification documentation | |
28 Personnel training documentation | |
29 Documentation of personnel skills | |
30 Documentation of personnel experience | |
SC4-Controlling | 1 Determination of policies and procedures for resolving complaints received from customers or other parties |
2 Documentation regarding complaints received | |
3 Documentation related to investigations of complaints received | |
4 Documentation regarding corrective actions taken | |
5 Determination of policies and control procedures for inappropriate testing work | |
6 Increasing the effectiveness of the management system on an ongoing basis | |
7 Determination of policies and procedures for carrying out corrective actions | |
8 Determination of preventive action procedures for nonconformity and policy deviation | |
9 Establishing schedules and procedures for internal audits | |
10 Periodic internal audits | |
11 Testing activities are included in the elements that must be audited | |
12 Planning and organizing audits by quality managers | |
13 The audit is carried out by trained personnel and independent of the audited activities | |
14 Schedule and procedures for laboratory management review | |
15 Periodic implementation of laboratory management reviews | |
SC5-Service sales | 1 Determination and maintenance of customer request review procedures |
2 Determination of tender review procedures | |
3 Determination of procedures for reviewing test contracts | |
SC6- Service planning | 1 Determination of test sampling procedures |
2 Determination of procedures for recording test sample data | |
3 Seek feedback from customers through customer surveys | |
SC7-Resources | 1 Subcontract testing work |
2 Reporting on test results | |
3 Determination of transportation procedures for goods tested | |
4 Determination of procedures for receiving goods tested | |
5 Determination of procedures for handling goods tested for deterioration, loss, or damage | |
6 Determination of procedures for protecting goods tested | |
SC7-Resources | 7 Determination of procedures for storing goods tested |
8 Determination of procedures for identifying items tested | |
9 Recording the condition of items tested when received by laboratory staff | |
10 Consultation with customers if the goods received are not in accordance with existing specifications | |
11 Determination of policies and procedures for selecting and buying services and supplies | |
12 Procedure for purchasing reagents and disposable materials | |
13 Procedure for receiving reagents and disposable materials | |
14 Procedure for storing reagents and disposable materials | |
15 Conduct evaluation towards supplier of disposable materials, supplies, and services | |
16 Energy source is adequate | |
17 Lighting is sufficient | |
18 Adequate environment | |
19 Procedure for guaranteeing accommodation conditions and laboratory environment | |
20 Procedure for access to laboratory space | |
21 Procedure for using laboratory space | |
22 Use of appropriate methods and procedures for all tests performed | |
23 Equipment operating instructions | |
24 Instructions for handling and preparing items tested | |
25 Procedure for estimating measurement uncertainty | |
26 Equipment handling procedures | |
27 Equipment removal procedure | |
28 Equipment storage procedure | |
29 Procedure for using tools | |
30 Equipment maintenance procedures | |
SC8-Quality | 1 Calibration of equipment |
2 Equipment calibration programs and procedures | |
3 Intermediate check | |
4 Quality control procedures | |
5 Analysis of quality control data | |
SC9-Information system management | 1 Document control procedures |
2 Quality and technical documentation control procedures | |
3 Internal audit report | |
4 Management review report | |
5 Reports on corrective actions | |
6 Preventive action report | |
7 Procedure for the protection and backup of records stored electronically | |
9 total subcriteria | 117 total indicators |
Category | Laboratory |
---|---|
Engineering | Material Lab (L2) |
Nano Bioenergy Lab (L3) | |
Thermodynamic Lab (L4) | |
Structural Lab (L5) | |
Mechanics Lab (L11) | |
Ergonomic Lab (L12) | |
Basic Chemistry Lab (L13) | |
Agriculture | Soil Fertility Lab (L6) |
Soil Conservation Lab (L7) | |
Biotechnology Lab (L8) | |
Plant Breeding Lab (L9) | |
Plant Physiology Lab (L10) | |
Food technology | Food Biochemistry Lab (L1) |
Laboratory | Total Indicators Fulfilled | Indicators Fulfillment Percentage |
---|---|---|
L1 | 46 | 39% |
L2 | 60 | 51% |
L3 | 26 | 22% |
L4 | 56 | 48% |
L5 | 55 | 47% |
L6 | 43 | 37% |
L7 | 45 | 38% |
L8 | 44 | 38% |
L9 | 24 | 21% |
L10 | 25 | 21% |
L11 | 55 | 47% |
L12 | 31 | 26% |
L13 | 25 | 21% |
Criterion | Subcriterion | Indicator Fulfillment Percentage |
---|---|---|
Management | Planning | 25% |
Organizing | 75% | |
Staffing | 44% | |
Controlling | 19% | |
Marketing | Service selling | 0% |
Service planning | 54% | |
Operation | Resources | 45% |
Quality | 12% | |
Management information system | Information system management | 20% |
Dimension | Readiness Level | Evidence | Proposed Improvement |
---|---|---|---|
Planning (SC1) | 25% | Lack of organized management system | State quality management system policies and objectives Compose documents regarding quality guide, procedures, job instructions, and activity forms |
Undocumented laboratory policies, procedures, programs, and job instructions | |||
Lack of quality manual | |||
Unstated objective and policy regarding laboratory quality | |||
Organizing (SC2) | 75% | Undivided responsibilities between technical and quality management | Recruit new personnel to carry out both responsibilities |
Staffing (SC3) | 44% | Lack of quality manager | Recruit new qualified personnel |
Lack of personnel training policy and procedure | |||
No relevant documentation of personnel’s competency, education, qualification, training, skill, and experience | Conduct documentation compiling training for laboratories personnel | ||
Controlling (SC4) | 19% | Lack of policy and procedure to resolve customer complaints | Conduct training for laboratories personnel on how to compile documents regarding laboratory quality management system and how to establish policies and procedures regarding test conduction |
No documentation of customer complaints, investigation, and corrective action towards them | |||
No established policy and procedure to conduct corrective action | |||
Lack of procedure to prevent nonconformity and policy deviation | |||
Lack of audit planning and organizing | |||
Lack of schedule and procedures for laboratory management review | |||
Lack of periodic laboratory management review | |||
Service selling (SC5) | 0% | Lack of customer request, tender, and contract review procedure | Formulate required procedures |
Service planning (SC6) | 54% | Low interest of laboratories to seek feedback through customer survey | Conduct customer satisfaction survey to improve service and management |
Resources (SC7) | 45% | Lack of procedure to receive, handle, protect, and identify test items | Invest in equipment and develop testing parameters especially for prioritized product produced by the university |
Lack of policy and procedure for selecting and buying services and supplies | |||
Lack of procedure to purchase and receive reagents and disposable materials | |||
No evaluation towards supplier was conducted | |||
Lack of procedure for guaranteeing accommodation conditions and laboratory environment | |||
Lack of procedure to estimate measurement uncertainty | |||
Quality (SC8) | 12% | Lack of equipment handling and calibration procedure | Formulate calibration and intermediate check procedures and make the schedule and program |
No intermediate check was conducted | |||
Lack of quality control procedure and data analysis | |||
Information system management (SC9) | 20% | Lack of document controlling procedure, corrective and preventive action report | Formulate the required procedures and develop a management information system software to monitor the laboratory activities |
Lack of record backup making and protection procedure |
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Aqidawati, E.F.; Sutopo, W.; Zakaria, R. Model to Measure the Readiness of University Testing Laboratories to Fulfill ISO/IEC 17025 Requirements (A Case Study). J. Open Innov. Technol. Mark. Complex. 2019, 5, 2. https://doi.org/10.3390/joitmc5010002
Aqidawati EF, Sutopo W, Zakaria R. Model to Measure the Readiness of University Testing Laboratories to Fulfill ISO/IEC 17025 Requirements (A Case Study). Journal of Open Innovation: Technology, Market, and Complexity. 2019; 5(1):2. https://doi.org/10.3390/joitmc5010002
Chicago/Turabian StyleAqidawati, Era Febriana, Wahyudi Sutopo, and Roni Zakaria. 2019. "Model to Measure the Readiness of University Testing Laboratories to Fulfill ISO/IEC 17025 Requirements (A Case Study)" Journal of Open Innovation: Technology, Market, and Complexity 5, no. 1: 2. https://doi.org/10.3390/joitmc5010002
APA StyleAqidawati, E. F., Sutopo, W., & Zakaria, R. (2019). Model to Measure the Readiness of University Testing Laboratories to Fulfill ISO/IEC 17025 Requirements (A Case Study). Journal of Open Innovation: Technology, Market, and Complexity, 5(1), 2. https://doi.org/10.3390/joitmc5010002