Note that the Risks will differ between laboratories, depending on the organisation structure and field of work. For example some laboratories have addition regulations to comply with, e.g. Veterinary or Medical Cannabis testing or calibration laboratories.
In all cases the priority is to identify possible risks that could impact on you not meeting your objectives.
- Ineffective QMS - A common example is the risk that laboratory policies and objectives are not aligned with your context. For example while turnaround time is a key performance requirement for an internal quality control laboratory due to production impact, yet turnaround time is not one of the established objectives. Impact a) operational performance.
- Risks to impartiality – examples are given in the standard, for example personal relationships, shared resources. Example Impartiality due to Shared Resources, where Preference given to production personnel for use of shared resources. Impact a) operational performance (Delay in turnaround time for lab test results). b) Quality (undue pressure on lab personnel, resulting in deviations).
- Risks related to statements of conformity if the decision rule to include or exclude Measurement Uncertainty is not suitable. This can result in a false pass or false fail Impact a) Quality b) Legal / Regulatory
- Risk levels not considered when taking corrective action for nonconforming work. Impact a) Financial (wasted resources) and b) Quality and Operational (reoccurring non-conformances).
- Ineffectiveness of activities, for example Management Review. Impact a) If MR itself is not effective, then risks will go unidentified. Impact a) Financial, Operational and Reputation
A tip – find out or ask your accreditation body about the top 5 or 10 deficiencies in laboratories in your sector – and then look at the risk you may have vulnerabilities on those topics, for example Technical Records.