Diagnosis of clause of ISO/IEC 17025:2017, “Actions to address the risk and opportunity (Option A)” ~ Part-1

In this article as part-1 we will discuss about clause 8.5.1.

Here with furnishing clause 8.5, “Actions to address the risk and opportunity (Option A)” as it is, from ISO/IEC 17027:2017 as below:

Before going for diagnosis of clause, it is suggested to read the clause in full without understanding the words and line by line.

8.5 Actions to address risks and opportunities (Option A)

8.5.1 The laboratory shall consider the risks and opportunities associated with the laboratory activities in order to:

a) Give assurance that the management system achieves its intended results;

b) Enhance opportunities to achieve the purpose and objectives of the laboratory;

c) Prevent, or reduce, undesired impacts and potential failures in the laboratory activities;

d) Achieve improvement.

8.5.2 The laboratory shall plan:

a) Actions to address these risks and opportunities;

b) how to:

— integrate and implement these actions into its management system;

— evaluate the effectiveness of these actions.

NOTE Although this document specifies that the laboratory plans actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Laboratories can decide whether or not to develop a more extensive risk management methodology than is required by this document, e.g. through the application of other guidance or standards.

8.5.3 Actions taken to address risks and opportunities shall be proportional to the potential impact on the validity of laboratory results.

NOTE 1 Options to address risks can include identifying and avoiding threats, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2 Opportunities can lead to expanding the scope of the laboratory activities, addressing new customers, using new technology and other possibilities to address customer needs.

Now,

8.5.1 The laboratory shall consider the risks and opportunities associated with the laboratory activities

Risks and opportunities associated with the laboratory activities to be address with use of PESTEL tool or by SWOT analysis.

The abbreviation of PESTEL as below:

SWOT analysis:

It is a tool use to identify the Strength, Weaknesses, Opportunity and Threats

The example of PESTEL Tool is as below:

The content in each category as stated in above table shall be change as per law of land and other factors if any.

But, if we study standard ISO/IEC 17025:2017 we can find that, some of the clauses are related to risk and same to be considered to address risk and opportunity.

The clauses are 4.1.4, 4.1.5, 7.8.6.1 and 7.10.1b

a) Give assurance that the management system achieves its intended results;

This simply means that organization has to give assurance about management system, that system will achieve its intended results.

Now question is what are intended results?

First up all what is mean by intended, it’s simply meaning as planned, proposed, projected, anticipated etc.

So, what we planned (Intended),

We plan for KPI (Key Process Indicators) which are always (as far as possible) in line with Quality Policy. So the outcome (Target vs. Actual) of KPI is our intended results.

b) Enhance opportunities to achieve the purpose and objectives of the laboratory;

How to achieve these KPI/Objectives has been very well addressed in ISO9001:2015 clause no 6.2.2 and details as below.

In terms of achievement of the quality objectives the organisation has to determine

• What will be done
• What resources will be required
• Who will be responsible
• When it will be completed
• How the results will be evaluated

As an example, this can be tabulated as below:

*For Z- Score, refer my article.

c) Prevent, or reduce, undesired impacts and potential failures in the laboratory activities;

d) Achieve improvement.

Diagnosis and How to?

• To reduce the undesired impacts and potential failures in the laboratory activities and also achieve improvement, it has been ensured that objectives are quantifiable, measurable and verifiable and correlate to the commitments made under Quality Policy.
• Measurable quality objectives for relevant functional levels are defined, monitored and   reviewed in Management Review Meeting.

Also,

• For meeting  objectives, proper planning is done by considering following aspects: 
  • Processes and their interactions( this is nothing but to make Turtle diagram for each processes, not recommended for this standard)
  • Procedures
  • Resources required for monitoring, measurement and analysis and action to be taken if planned results are not obtained.

We will diagnose clause 8.5.2 and 8.5.3 in next article in part-2.

Reference source: ISO/IEC 17025:17