Submitted:
05 January 2024
Posted:
10 January 2024
You are already at the latest version
Abstract
Keywords:
1. Introduction
2. Materials and Methods
- Level of importance: 1-LOW IMPORTANCE, 2-IMPORTANT, 3-VERY IMPORTANT.
- Implementation difficulty level: 1-VERY EASY, 2-EASY, 3-MODERATE, 4-DIFFICULT, 5-VERY DIFFICULT.
3. Results and Discussion
3.1. Bibliographic Research
3.2. Field Research
3.3. Case study (Focus Group)
- Fellows´ length of stay in projects: the short length of stay and high turnover affect service performance, as there is a need for recurrent training of new members;
- Multipurpose laboratories (teaching, research, and services): in multipurpose laboratories, there is difficulty in implementing access controls necessary to comply with the ISO 17025 standard;
- Infrastructure adequacy: Some laboratories within universities need structural adjustments that make it challenging to establish material transport flows, another requirement of standard ISO 17025.
3.4. Maturity Model
4. Conclusions
- Develop a measurement scale for the maturity model based on methods such as Multi-Criteria Decision;
- Validate the proposed maturity model based on the evaluation of educational institutions’ laboratories (Benchmarking);
- Test and expand the model for laboratories with different characteristics from the research scope.
- Evaluate the contribution of the proposed maturity model to the success of project submission (scientific production);
- Evaluate the costs of implementing one or more management systems based on the Return on Investment (ROI).
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
Appendix A. Questionnaire Sent to Laboratory Managers
| A maturity model can be understood as a tool that helps companies understand the quality of their processes and establishes gradual transition stages until a level considered to be excellent is reached. |
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- MEG (PNQ)
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- CMM
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- CMMI
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- QMMG
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- ISO 9004
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- PM2
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- MMGP
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- PMM
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- BPMM
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- OPM-3
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- KMM
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- None
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- Others: ____________
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- Yes, which one? ______________
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- No
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- I can´t say
| 1 | 2 | 3 | 4 | 5 | ||
| 2.3.1 | A Maturity Model applicable to the laboratory setting helps guide the gradual adoption of management practices to improve internal and external processes. | |||||
| 2.3.2 | A Maturity Model applicable to the laboratory setting helps define differentiation strategies between competing laboratories, enabling market gains. |
| 1 | 2 | 3 | 4 | 5 | ||
| 2.4.1 | Identify all stakeholders in the laboratory's activities and define their requirements for quality of services. | |||||
| 2.4.2 | The laboratory recognizes the external and internal factors that may offer risks and opportunities for its work to continue. | |||||
| 2.4.3 | Acknowledging the Value Chain and its respective processes linked to strategic indicators. | |||||
| 2.4.4 | Definition of strategic information, processes, and stakeholders, selecting the most important ones for decision-making. | |||||
| 2.4.5 | Establishment of relationship channels with stakeholders to handle requests, complaints, and suggestions. | |||||
| 2.4.6 | Market analysis and segmentation. Definition of target customers and assessment of satisfaction, loyalty, and dissatisfaction. | |||||
| 2.4.7 | Identification, selection, qualification, and performance evaluation of suppliers. Performance communication. | |||||
| 2.4.8 | Selection and qualification of workers. Performance evaluation. | |||||
| 2.4.9 | Treatment of health and safety hazards and risks. Promotion of improved quality of life, well-being, and satisfaction. | |||||
| 2.4.10 | Identification of existing strengths and gaps in management. Definition of current and future competencies. | |||||
| 2.4.11 | Identification, development, retention, and protection of knowledge. | |||||
| 2.4.12 | Induction, development, and implementation of innovation. | |||||
| 2.4.13 | Identification of capacity for change, including assessment of need and capacity for implementation. | |||||
| 2.4.14 | Assessment of flexibility for changes, including review of strategies, goals, processes, and products at an appropriate time. | |||||
| 2.4.15 | Definition of values, principles, guidelines, and standards of conduct. Ethical relationship with stakeholders. | |||||
| 2.4.16 | Risk management, compliance with legal requirements, and transparency with stakeholders. | |||||
| 2.4.17 | Mapping of organizational culture to implement strategies and practice values. | |||||
| 2.4.18 | Performance analysis of indicators and monitoring of action plans and their resources | |||||
| 2.4.19 | Definition of leadership competencies and leader development. | |||||
| 2.4.20 | Defining and monitoring economic-financial indicators, cost management, budget, and fiscal control. | |||||
| 2.4.21 | Prevention, treatment, and monitoring of environmental impacts. Quick response to emergencies. | |||||
| 2.4.22 | Prevention, mitigation, and monitoring of social impacts. | |||||
| 2.4.23 | Implementation of information systems with the establishment of security requirements. | |||||
| 2.4.24 | Mapping, analysis, and improvement of laboratory processes. | |||||
| 2.4.25 | Identification of new product development opportunities |
| Management Systems can be understood as interrelated and interdependent management practices and methods with pre-defined objectives and goals that help companies continuously improve in managing specific areas, such as Quality, Environment, and others. |
| 1 | 2 | 3 | 4 | 5 | ||
| 3.1.1 | Adopting a certifiable Management System optimizes the laboratory's internal processes. | |||||
| 3.1.2 | Adopting a certifiable Management System enhances the contracting of new services by the laboratory. | |||||
| 3.1.3 | Adopting a certifiable Management System leads to rigid laboratory internal processes. | |||||
| 3.1.4 | Adopting a certifiable Management System increases laboratory operating costs. | |||||
| 3.1.5 | Adopting a certifiable Management System increases the complexity of laboratory management. | |||||
| 3.1.6 | Adopting a certifiable Management System requires hiring more professionals to deal with the documents generated by the system. | |||||
| 3.1.7 | Adopting the ABNT NBR ISO 17025:2017 standard to improve the quality of operations, compared to what we currently have, is relevant to the laboratory. | |||||
| 3.1.8 | Adopting the ABNT NBR ISO 9001:2015 standard for implementing a quality management system for internal processes, compared to what we currently have, is relevant to the laboratory. | |||||
| 3.1.9 | Adopting the ABNT NBR ISO 14001:2015 standard for implementing an environmental management system for internal processes, compared to what we currently have, is relevant to the laboratory. | |||||
| 3.1.10 | The adoption of the ABNT NBR ISO 45001:2017 standard for implementing an occupational health and safety management system for internal processes, compared to what we currently have, is relevant to the laboratory. | |||||
| 3.1.11 | Compared to what we currently have, adopting the ABNT NBR ISO 31000:2018 standard for implementing a risk management system for internal processes is relevant to the laboratory. |
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- Statement of Impartiality (Document)
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- Statement of Reliability (Document)
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- Documentation of laboratory activities
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- Skills requirements for roles (Document)
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- Equipment Calibration Program
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- Equipment Operation and Maintenance Procedures
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- Monitoring and control of environmental conditions and facilities
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- Metrological Traceability
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- Documented, updated, and validated methods and procedures
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- Laboratory management software
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- Analysis of risks and opportunities
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- Critical orders analysis
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- Critical analysis of the results
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- Critical analysis of non-conformities
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- Others: ____________
| Quality | Environment | Occupational Health and Safety | Risks and opportunities | Does not adopt | |
| Management manual | |||||
| Policy | |||||
| Goals and objectives | |||||
| Written instructions and procedures | |||||
| Performance indicators | |||||
| Scheduled inspections | |||||
| Audits |
| Certified | Certification in progress | With the implementation in progress | Does not have | |
| ABNT NBR ISO 17025:2017 | ||||
| ABNT NBR ISO 9001:2015 | ||||
| ABNT NBR ISO 14001:2015 | ||||
| ABNT NBR ISO 45001:2018 | ||||
| ABNT NBR ISO 31000:2018 | ||||
| Others: _______________ |
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- Lack of Human Resources
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- Lack of Financial Resources
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- Lack of infrastructure
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- Institution regulations
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- Uncertainty regarding return on investment
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- Low interest from management
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- Employee resistance to change
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- Others: ____________
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- 5S Program
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- FMEA
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- Process Mapping
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- Process Quality Control
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- Determining customer requirements
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- Measuring customer satisfaction
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- Others: ____________
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- Effluent treatment
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- Conscious consumption (water/energy)
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- Waste sorting
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- Proper waste disposal
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- 3R/5R Program
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- Assessment of Environmental Aspects and Impacts
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- Others: ____________
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- Good Laboratory Practices - GLP
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- Chemical Compatibility Chart
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- Labeling System
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- PPE training
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- Risk Management Program – RMP
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- Environmental Risk Prevention Program – PPRA
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- Occupational Health Medical Control Program – PCMSO
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- Fire prevention and fire fighting measures
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- Hazard and Risk Assessment
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- Others: ____________
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- Brainstorming
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- Checklists
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- Preliminary Risk Analysis – PRA
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- Hazard Analysis and Critical Control Points – HACCP
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- Failure Modes and Effects Analysis – FMEA
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- Reliability Centered Maintenance – RCM
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- Cause and Effect Analysis
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- Probability and Consequences Matrix
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- Others: ____________
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| Dimensions | Subdimension | Management Practices | 1st version level | Validated Practice | Validated Level | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| MM level | Preparation level | MM level | Preparation level | |||||||
|
1. Strategy |
Initial diagnosis | PE | 1.5 | The laboratory has identified stakeholders' quality, safety, and environmental requirements. | N5 | N2 | ok | ok | N1 | |
| PE | 1.8 | The laboratory recognizes the Hazards and Safety Risks of its operations. | N5 | N2 | ok | ok | N1 | |||
| Assumptions | Justifications |
|---|---|
| Use the ISO standards structure to build the maturity model. | Field research revealed that the ISO 9004 standard is the best-known model for participants. Affinity with the terms of the normative requirements and the ISO standards structure facilitates understanding and model acceptance. “All requirements in this Standard are generic and intended to apply to all organizations, regardless of their type, size, and the product and service they provide” [22] (p. 3). |
| Start implementation using the ISO 17025 standard, followed by ISO 9001. | Field research revealed that they are the most relevant standards for laboratories on a scale of priorities. “The implementation of an IMS is less bureaucratic when companies already have at least one QMS implemented [...]” [28] (p. 34). |
|
Deployments must occur in a sequenced manner (Step-by-Step). |
Field research revealed that the laboratories´ main complaints refer to resource constraints. |
|
Implementing the requirements in the ISO 31000 standard must be carried out in conjunction with the ISO 9001 standard. |
“[...] a risk management approach must accompany the implementation of an IMS, this being the integrating factor and the OHSMS being the pivot management subsystem, removing the focus from the QMS. Implicitly or explicitly, risk analysis is present in all subsystem references.” [28] (p. 23). |
|
There is no certification requirement to change levels. |
The standards are not compulsory but operate by adhesion. Certification requires periodic maintenance of certificates. The decision for certification should consider a cost-benefit analysis. |
|
Management systems with fully integrated documents. |
“[...] when systems are implemented in an integrated way and within a strategic and systemic vision, benefits are increased because processes are optimized [...])”. [28] (p. 34). Improving system integration contributes to Sustainability and points to building ways to bring system maturity to higher levels. [2]. Investment in management systems improved the performance of companies' economic, social, and environmental aspects (TBL) [13]. |
| Preferred focus on internal and external processes. | Field research revealed that using management systems in university laboratories has a more excellent perception of relevance for improving internal and external processes. “Internal or predominantly internal motivations are the “driving force” that leads companies to integrate their management subsystems” [28] (p. 24). |
| The model has 6 (six) maturity levels. | Creating Level 0 resulted from adjustments to the levels of preparation of management practices arising from the experience of the laboratory's management and operation team. |
| Dimensions | Subdimension | Management Practices | MM level | Preparation level | |||
|---|---|---|---|---|---|---|---|
| 1. Strategy | Initial diagnosis | PE | 1.1 | The laboratory recognizes the external and internal factors that may offer risks and opportunities for its work to continue. | N3 | N2 | |
| PE | 1.2 | The laboratory has its macro processes mapped and linked to the Value Chain. | N3 | N2 | |||
| PE | 1.3 | The laboratory has identified all stakeholders. | N3 | N2 | |||
| PE | 1.4 | The laboratory has an established organizational identity with a Vision, Mission, and Values. | N2 | N1 | |||
| PE | 1.5 | The laboratory has identified the quality, safety, and environmental requirements of stakeholders. | N5 | N1 | |||
| PE | 1.6 | The laboratory recognizes the Critical Success Factors for the quality of its operations. | N2 | N1 | |||
| PE | 1.7 | The laboratory recognizes its operations' environmental aspects and impacts based on the Life Cycle of its services. | N4 | N3 | |||
| PE | 1.8 | The laboratory recognizes the Hazards and Safety Risks of its operations. | N5 | N1 | |||
| Strategy Formulation | PE | 1.9 | The laboratory's strategic planning considers the institution's PDI guidelines. | N3 | N2 | ||
| PE | 1.10 | The laboratory considers the requirements of Impartiality and Confidentiality when formulating its strategy. | N2 | N1 | |||
| PE | 1.11 | The laboratory considers stakeholder requirements in formulating the strategy. | N2 | N1 | |||
| Dimensions | STARTED | SUITABLE | DIFFERENTIATED | MANAGED | INTEGRATED | MAINTAINED |
|---|---|---|---|---|---|---|
| LEVEL 0 | LEVEL 1 | LEVEL 2 | LEVEL 3 | LEVEL 4 | LEVEL 5 | |
| 1. Strategy | At this level, the laboratory is at the beginning of its operations. It has no defined strategic actions, just routine operations. | At this level, the laboratory has not yet defined strategic actions, but it is starting to develop its mission, vision, and values. It also initiates the recognition and involvement of interested parties in the implementation and (subsequent) integration processes, the analysis of the Critical success factors, and acknowledges OSH risks and hazards in its operations. | The laboratory's operational activities are based on the ABNT NBR ISO/IEC 17025 standard. It also has a Mission, Vision, Values, critical success factors, requirements for Reliability and impartiality, and Stakeholders linked to its strategy. At this level, the laboratory starts (among other activities) to recognize external and internal factors that affect it, links the macro processes mapped to its Value Chain, and integrates systems beginning at the highest level. | At Level 3, the laboratory is certified (or operates) according to the ABNT NBR ISO 9001 standard, is accredited according to the ABNT NBR ISO/IEC 17025 standard, and operates according to the requirements of the ABNT NBR ISO 31000 standard. At this level, the laboratory considers aspects of quality and risk when formulating its strategy and has strategic indicators linked to microprocessors. At this level, the laboratory also begins to survey the environmental aspects and impacts of its operations based on the Life Cycle of its services. It begins to develop its environmental management system. | At Level 4, the laboratory is accredited (or operates) according to the ABNT NBR ISO/IEC 17025 standard. It is certified or operates according to standards ABNT NBR ISO 9001, ABNT NBR ISO 31000, and ABNT NBR ISO 14001. The laboratory recognizes its operations' environmental aspects and impacts and considers environmental aspects when formulating the strategy. At this level, the laboratory uses the recognition of hazards and risks to begin implementing the OSH management system. | At Level 5, the laboratory is accredited according to the ABNT NBR ISO/IEC 17025 standard. It is certified or operates according to standards ABNT NBR ISO 9001, ABNT NBR ISO 31000, ABNT NBR ISO 45001, and ABNT NBR ISO 14001. The laboratory recognizes the hazards and risks of its operations and considers OSH aspects when formulating its strategy. |
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