Risk & opportunities for food testing laboratory

The standard specifies the need for the following, related to risks and opportunities:

1. Consider them
2. Plan how to address them
3. Take action proportional to the potential impact on the validity of the results  (i.e. positive impact in the case of opportunities, and negative impact in the case of risks)
4. Evaluate the effectiveness of the actions taken
    

To “consider “means to think carefully about the risks and opportunities before making a decision. Central to all decision making is thinking about the risk or opportunity for improvement in terms of ensuring and safeguarding the laboratory’s defined quality objectives. These objectives should be aligned to the requirements of the standard. i.e. impartiality, competence and consistent operation.

The “considering” process can involve various methodologies and tools, including process mapping, brainstorming and use of the Plan-Do-Check-Act (PDCA) cycle. Start with mapping your processes and brainstorming. The best approach is produce a Registry of Key Risks and Opportunities, with suitable columns, including for example description, responsibility. For each activity ask the question – is there a risk to safeguarding impartiality, competence or consistent operation? If the answer is yes, in order to meet the requirement of point two and three above, you need to first evaluate risks and opportunities using a risk matrix, considering the existing controls already in place. Once the risks and opportunities are ranked in priority (high to low), you can move to planning how to firstly reduce the high risks; and implement the opportunities found to have a high benefit-to-risk (of implementing) ranking. Choose the actions that are most likely to reduce or control the risk, or ensure success of improvement. Assign responsibility and due date.

Finally, as with any laboratory activity, the efficiency of the activity must monitored. This can be done through existing activities such as nonconforming events, internal audits and management review. Show evidence of this evaluation by updating the risk register and recording the date of last review.

Have a look at the following articles, which will provide more guidance:

• Five-step laboratory risk management according to ISO 17025:2017 https://advisera.com/17025academy/blog/2019/12/05/iso-17025-risk-management-in-five-steps/
• Plan-Do-Check-Act in the ISO 9001 Standard, also applicable to ISO 17025 https://advisera.com/9001academy/knowledgebase/plan-do-check-act-in-the-iso-9001-standard/

The ISO 17025 procedure and registry template are available stand-alone, or part of the toolkit:

• Addressing Risks and Opportunities Procedure https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/
• Registry of Key Risks and Opportunities https://advisera.com/17025academy/documentation/registry-of-key-risks-and-opportunities/