I'm the Quality Manager at a testing lab, and I'm working on a training presentation for staff on 'risks to impartiality'. I will be asking them to report any identified risks to their supervisor and one of the examples of a risk to impartiality I'm giving as one that is likely to occur is 'pressure on lab staff due to an unforeseen event (e.g. equipment failure, delay in receiving supplies etc.) I believe that these are risks to impartiality as they do put the staff under stress which can lead to cutting corners if they aren't properly mitigated. I'm just wondering if I'm correct or if these types of pressures are not exactly what is meant by risks to impartiality. If they are considered risks, is there a good way to communicate these? I feel like these ones are not what most expect as a risk to impartiality as most think of Conflicts of Interest. Thanks for any information you can provide.
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Yes, you are correct in your interpretation. A laboratory needs to consider possible risks to impartiality (in terms of the definition of impartiality), then identify any that may be possible (even if low probability) in your context (what you do, who your clients and external providers are, and what your organizational structure is). They are many aspects that are covered under impartiality. These are explained in the definition of impartiality in ISO 17025, where impartiality is simply the
presence of objectivity; meaning there are no conflicts of interest (or they are resolved/safeguarded)are resolved so that there are no factors that can negatively influence activities of the laboratory. Look at the standard for the other terms such as “freedom from bias”. So anything that will impact any established policies including a Code of Conduct. For example, personnel is put under undue pressure where they have to as you say take shortcuts that may jeopardize the results. Everything must be in place to ensure competent, consistent operations. i.e. consistently valid results.
You asked
is there a good way to communicate these?
Through risk analysis and the use of tools showing cause and effect, and fishbone diagrams. Involve all relevant personnel. Use brainstorming and set out a process chart for an activity showing the inputs and outputs and the influencing factors. Then indicate the controls in place. Using your risk register indicate whether with those current controls (risk treatment) if the risk is at an acceptable level or not. Then record how you will monitor the effectiveness over time – for example, monthly meeting discussions, when onboarding new personnel, clients, or suppliers, and during internal audits,
For more information, have a look at the advice answers
Compliance with the ISO/IEC 17025:2017 requirement for Impartiality - https://community.advisera.com/topic/compliance-with-the-isoiec-170252017-requirement-for-impartiality/
Procedure for impartiality - https://community.advisera.com/topic/procedure-for-impartiality/
The ISO 17025 document template: Registry of Key Risks and Opportunities, is available for as part of the toolkit for preview and purchase separately too at https://advisera.com/17025academy/documentation/registry-of-key-risks-and-opportunities/
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Jan 18, 2023