Jun 01, 2015  Risk-based thinking refers to thinking ahead of a situation (as in a chess game) to consider threats and opportunities and their possible effects on a specific goal, in order to take the necessary actions that will allow us to maintain or improve the desired results. Risk-based thinking refers to thinking ahead of a situation (as in a chess game) to consider threats and opportunities and their possible effects on a specific goal, in order to take the necessary actions that will allow us to maintain or improve the desired results.

One new section in the ISO/IEC 17025:2017 standard is section 8.5 – Actions to address risks and opportunities. While the wording may be new, the concepts are not. Take a closer look at the concept of risk in the new standard.

Clause 8.5.1 of the ISO/IEC 17025:2017 standard states that “The laboratory shall consider the risks and opportunities associated with the laboratory activities in order to….”. All laboratories consider risks and opportunities every day, but the challenge is being able to demonstrate conformance with this requirement. For example, a laboratory performing microbiological methods that rely on a colour reaction (for example, reading plates, reading Presence/Absence results, or reading Quantitrays) perform inter-analyst reading comparisons. Why is this done? While most laboratories may respond “Because it’s a CALA requirement” the real answer is that it is to reduce the risk that a false negative or false positive result is reported because of differences in the competence of personnel. (As an aside, you can also see that prescriptive requirements or checklists can help to mitigate risk).

Clause 8.5.2 requires that laboratories shall plan actions to address risks and opportunities, integrate and plan these actions into the management system, and evaluate the effectiveness of these actions. Fallen angel auto clicker.

In order to mitigate the risk that laboratories develop and implement expensive systems to meet clause 8.5, the note under clause 8.5.2 states that there is “no requirement for formal methods for risk management or a documented risk management process”. However, while formal or documented risk management processes may not be required, remember that CALA still needs objective evidence that the laboratory is indeed considering risks and opportunities.

So what is your objective evidence that there is a plan in place to minimize the risk of false positives or false negatives being reported because one of the personnel misinterpreted a colour change? There is the record of the monthly inter-technician comparison readings. Are there others? Very likely. Go through your system and identify what they are, and other objective evidence you can show an assessor.

One effective way to manage the concept of “risk” is to set up a 3-column table with the headings: Risk, Probability (Low/Medium/High) and Actions.

• Start by listing the risks associated with a method or process. Generally we tend to list the things that could go wrong, but the clause also encompasses opportunities.
• Review the list and try to determine if the risk is low, medium, or high.
• What is being done right now in your system that eliminates or mitigates this risk?
• Is there a procedure in place?
• Are there records available to demonstrate that the procedure is being effectively implemented?

This exercise is really a simplified risk register. At the end of this exercise, you may be pleasantly surprised to see that your system is meeting Section 8.5 of the standard. While not required by the standard, it may prove to be a good tool and starting point for the laboratory to consolidate activities around risks and opportunities, and to provide objective evidence to CALA assessors and staff. As you get more comfortable with the concepts, you may develop other ways to demonstrate how the laboratory’s system meets the requirements.

Keep in mind is that this is not a one-time exercise. Although a good starting point, you need to think about risks and opportunities on an on-going basis. Risk comes into play when there are changes in the laboratory including, but not limited to, changes in personnel, procedures and equipment. The whole standard was written with a risk-based thinking approach, which is the main reason why many of the requirements are not as prescriptive as in the previous version of the standard. Part of the challenge is recognizing that risk-based thinking can be applied when implementing any of the clauses of the standard or processes in the laboratory.

Clause 8.5.3 is simply stating that if the risk is going to have a significant impact on the validity of the test results, then the subsequent action(s) should significantly reduce the risk. Conversely, if the risk is low, then there is no need to have all kinds of processes and procedures in place to eliminate or minimize the risk. Keep this in mind as you complete your analysis. The ‘notes’ under this clause refer to various different ways to address risk, and if you are not familiar with them, it is highly recommended that you do some more research or training on these concepts. CALA does offer training courses and webinars on risk; for a list of upcoming courses, please refer to: cala-training.myshopify.com

This page will be updated as the abstracts are received. Check back often.

Risk-Based Thinking: A Better Approach to Management System Effectiveness and Continuous Improvement – ANAB

This one-day (8 hour) workshop will review specific requirements in both ISO/IEC 17025:2017 and the AR 3125 that incorporate the word risk as well as those requirements that foster a risk-based thinking approach. We will explore the relationship between a process, risk-based thinking management system approach and continuous improvement. But, to understand a risk-based thinking approach, we first need to know “what is risk”? Is it the same for all forensic service providers? Does size matter? Does discipline matter? Is it the same for all scenarios? We will define and discuss risk as it applies to the forensic laboratory and present several risk-based thinking approaches and tools for identifying, assessing, addressing and monitoring risks. Workshop participants will then apply this basic framework of risk-based thinking through group exercises. Course participants will gain an understanding of the ISO/IEC 17025:2017 requirements regarding risk as well as those requirements that foster risk-based thinking. Participants will also become familiar with various tools and resources available for implementing a risk-based thinking approach and be more prepared for the identification and evaluation of risks and opportunities in their own management system.

Registration fee is $150. Register now!

Safety In the Laboratory – Lab Safety

CANCELLED.

Qualtrax: Assessing and Documenting Risk: Using Customized Workflows to Comply with ISO 17025:2017

3:30-5:00 pm

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The increased scope of ISO 17025 now includes risk management, adding new pressure for Quality Professionals, who must re-examine their current practices. Is your organization equipped to meet the evolving demands of accreditation? Is your Quality Management System flexible enough to conform to the unique processes your organization uses to assess risk?

In this session, Ranee Ho, the Quality Assurance Manager for the Metropolitan Nashville Police Department, will share how her organization has deployed Qualtrax’s Risk Assessment Workflow to measure, monitor and document risk. She will be joined by Tim Akin, a member of the Qualtrax training team, to walk through the Qualtrax Risk Assessment Workflow and answer questions about how it can be configured to meet the needs of your organization.

If your organization is currently looking for guidance on implementing a risk management and documentation process, you can’t afford to miss this session! Register now!

MORNING

–> Leadership Training
Rick StBlancard

TBA

–> Validation vs. Performance Check
Richard Remy

This workshop will go over the requirements necessary to ensure quality validations and the differences between validations and performance checks. This class is designed for the newly appointed quality assurance manager, any quality manager transition to ISO 17025:2017 standards, or any quality manager that want to review validation and performance check requirements. Planning, selection of methods, assessment of validation parameters and documentation will be discussed through classroom style lecture. Attendees will also participate in hands on practice of validation exercises.

–> A New Concept (Well … Not Really): Risks and Opportunities
Anja Einseln

When first reading the new version of ISO/IEC 17025 (2017), General Requirements for the Competence of Testing and Calibration Laboratories, a forensic Quality Assurance Manager may pause when they reach clause 8.5, titled ‘Actions to Address Risks and Opportunities.’ And then sit quietly. And try to decipher what this means. It will be a new label that we can apply to many of our existing forensic quality assurance activities. It may also require a slightly different perspective on how we manage and plan in our organizations. Is change pleasant? Typically, no. It is uncomfortable and many times, yet another item we have to put on our ‘list of things to do.’ The goal of this workshop is to help Quality Assurance Managers help their laboratory staff adjust to this requirement, with minimal disturbance to forensic casework.

AFTERNOON

–> Cultivating Responses to Stress to Strengthen the Quality of Work and Life
Amy Jeanguenat, Mindgen

There is open awareness in the forensic community that forensic examinations, quality of work, and error management are affected by human factors. Understanding and correctly managing human factors can enhance laboratory quality as well as improve the decision-making ability of forensic professionals. The study of stress and wellness in the workplace has occurred in multiple industries but, this area of human factors is still in its infancy within the forensic science domain.

Stress can occur anytime our needs are not met. High caseloads, fluctuating priorities, and working in an adversarial system often means personnel are constantly juggling many tasks. Quality assurance managers have unique roles in that they are managing every error that occurs in the laboratory while often themselves wearing other hats. When stress factors are repeated or constant, performance and productivity tend to decrease due to physical and psychological phenomena. Thus, stress becomes an important human factor to mitigate for overall error management, productivity and decision quality.

Through this workshop, participants will obtain a better understanding of how to recognize stress in themselves and others and how it may be affecting the quality of work and life.
Techniques such as mindfulness can become powerful tools for forensic professionals to employ to enhance decision making and resilience. Such resources can be cultivated throughout the day and activated during stressful moments to mediate their effects. Personal coping mechanisms to bounce back faster from stressful situations will be introduced. Discussion prompts will also foster communication on evidence-based methods organizations can offer to mitigate stress in employees.

–> Communication
Jessica Toms

TBA

–> Similarities and Differences Between ISO/IEC 17020 (2012) and ISO/IEC 17025 (2017)
Anja Einseln

How many people have spent time personally reading through ISO/IEC 17020? Probably not as much as you would like … similar to the list of books we all wish we had the to read. Yes, there are only so many hours and minutes in the day … and keeping an eye on your actual accreditation program probably consumes most of your bandwidth. This presentation will provide you with an opportunity to learn about how many similarities there are between these two documents as well as highlighting a few of the differences.