13/01/2020
Source:-. calibration awareness.com
Since the transition from the 2005 version to the 2017 version has started, I have received a number of comments regarding the ISO 17025 Impartiality procedure.
There is also a question like, “Is it Mandatory to have a procedure for impartiality?”
Just like many others, before I started to understand and create my own procedure, I have a hard time understanding the requirements of the standard.
Even though this subject about impartiality is not new (yes it is), which is already in the old version, Still, once it was presented in the new version with a separate clause, it was like it is my first time being exposed to it.
More so when I read the term “Risk Assessment“ for the identified Risk to Impartiality. When I started to create my process or procedure, I was stuck on what next to be done. One more thing that overwhelmed me is the statement, “Ongoing basis”.
When I was reading the standard, it seems that impartiality is easy to understand and implement, but once it is needed to be documented for a procedure, the challenge is now presenting itself.
The challenges are:
1..How can I identify the Risks to impartiality?
2. Once Identified, How can I perform evaluation or analysis?
3. How can I execute the Identification of risks to impartiality on an on-going basis?
3. How can I manage risk to impartiality implementation?
But luckily, after a good conversation with my assessor (which I am very grateful by the way he delivers his assessment), I finally understood what is missing in my own way of understanding this process.
And in this post, I will present with you the following:
Impartiality requirements as per ISO 17025:2017
Understanding Impartiality (terms and definitions)
The risk to Impartiality related clause and requirements
Commitment to impartiality
Impartiality implementation procedure (in 4 steps)
Identification and monitoring of risk to impartiality
Analysis and evaluation of Risk to impartiality- risk assessment
Addressing Risk – Eliminate and mitigate risk to impartiality
Identification on an Ongoing Basis
monitoring of risk to impartiality – maintaining impartiality
Impartiality Process Flow Chart
The implementation that I will present here is not yet perfect. These are the things that I have listed and implemented based on my understanding and design of the lab that I am in..this implementation is also new to me and therefore there is still more room for improvement.
This may not apply in your laboratory so proper care or review must be implemented. I hope that this will be a useful guide for you to understand and start to implement within your lab.
Understanding Impartiality and ISO 17025:2017 Impartiality Requirements
One reason to have honesty and integrity to laboratory results is to have an unbiased, and of course, accurate results. This can be achieved through the implementation of Impartiality, integrated into our laboratory activities and to be part of our work ethic.
To be impartial to the laboratory’s activities is being free to exercise your professional judgment and competency as per the actual data results that you have gathered using the established procedures..
After the new revision of iso 17025 has been released, impartiality has become one of the major requirements to be implemented or even integrated into all laboratory activities. This means it is a mandatory process that must be implemented.
It is not a new requirement, but this time, it has now a new clause with a clear and direct requirement for its implementation (see the clause below).
But being impartial to laboratory activities needs awareness in order to be understood and implemented smoothly. This is not a single person’s responsibility.
But like any other activity, by following a certain procedure or a system makes it more interesting and easy to implement (as it applies to me as per the system that I will share below.. Read on)
To start understanding Impartiality, I have included its definition from the standard. As per ISO 17025, clause 3.1 Impartiality means:
“The presence of objectivity.”
note to 3.1, stating that “Objectivity is understood to mean that conflicts of interest do not exist, or are resolved so as not to adversely influence the activities of the laboratory.”
are freedom from conflicts of interest,
Freedom from bias
freedom from prejudice,
neutrality,
Fairness,
open-mindedness,
even-handedness,
detachment
and balance
As per clause 4 of ISO 17025:2017 Standard, below are the General Requirements for Impartiality
Laboratory activities shall be taken impartially structured and manage so as to safeguard impartiality
The management shall be committed to impartiality
The laboratory shall ensure impartiality in all its activities and not allow commercial, financial or other pressures to compromise impartiality.
The laboratory shall Identify risk to impartiality on an on-going basis;
Once a risk to impartiality is identified, the lab should demonstrate how to minimize or eliminate such risk.
Below are some examples of impartiality in laboratory activities to understand it better.
No Conflict of interest – You are not auditing your own work during the scheduled internal audit
Detachment –Technicians are not involved in marketing where they perform the calibration –
Freedom from bias – You are not favoring any request that involves falsification of results
Fairness –The company is not pressuring you financially
Commitment to Impartiality
So how can we show that the management is committed in implementing impartiality?
It is difficult to implement impartiality or taking an action to solve the identified Risk to Impartiality without the support of the higher management.
The management should be committed in order to strengthen the support in the implementation
Ways to show commitment is by:
Including a statement about impartiality in the quality policy which is signed by the management.
Included on the discussions in the management review meeting
Included in the training program and performance review of the personnel during contract renewal.
Impartiality Procedure Implementation Requirements for ISO 17025:2017
The procedure for maintaining the impartiality of laboratory activities can be broken down into different steps or stages in order to understand its implementation easily.
I put “4 Steps” in the title but as you learn through it, each step has more steps on each own.
These steps are:
Step 1: Identify the risks to impartiality
Step 2: Analyze and Evaluate Identified Risks to Impartiality
Step 3: Addressing the Risk – Eliminate or Mitigate Identified Risk to Impartiality
Step 4: Identification to an On-going basis – monitoring
Identification of Risk to Impartiality
Now, this is where the main part where we need to sit and think.
There are techniques to determine the risks to impartiality. I will present here the techniques that I understand and make sense to me (and I hope for you too)
Read more about the techniques HERE
These techniques are:
Document Review – as the name implies, we will review all related documents, for example, audit results, contract review, procedures and many more.
Information gathering through Brainstorming and interviewing – this is a group work where we can extract inputs from the group during meetings or any scheduled meetups.
Expert Judgement – this is where our related experience and understanding of the standards and processes in the laboratory are very helpful
Checklist – a list of previously identified risks
Remember that at this stage, we need to identify the activities where impartiality could be at risk.. We need to list all that we can identify.
Note that the identified risk is not necessarily the activities that ‘already occurred’. Since we are in the identification stage, we will include even the potential risks that we assessed that may happen.
Where can we use these techniques you may ask?
In addition to the examples that are provided, the ISO 17025 standard has given us a guide where to look and identify those risks to impartiality.
These areas or activities where we can start to investigate are the relationships that exist inside the laboratory. We can use the techniques above on these relationships that normally occur where the risk to Impartiality is highly likely to happen, these are:
Company to personnel relationship
Laboratory activities to personnel relationship
Personnel to customer relationships
After we perform the above techniques, we will then summarize all the identified risks in a list and create a more defined impartiality risk assessment checklist.
Below are examples of identified risk to impartiality that you may include in your checklist as a result of the relationships that exist while performing laboratory activities.
Relationships of Company Management to Personnel
1. Salary is based on the number of calibrated UUC, this is a form of financial pressure.
2. Quality is reporting under Technical (structural)
3 The owner is the Lab Manager
Relationships of Laboratory Activities to Personnel
1.Auditing your own work during internal audit activity
2. The lab technician is performing marketing.
3. Special favor during the customer contract review
Relationships of Personnel to Customer
1. A special commission to favor the customer’s wants
2. The Customer request a specific technician or engineer to perform calibration
3. The technician performing calibration on the previous employer
And now, since we already identified them, it is now time to assess if the relationships above have a risk to impartiality. These relationships may or may not pose a risk depending on your assessment. Risk means that it has an effect on the quality of lab activities during the delivery of results. (calibration or test results)
Analyze and Evaluate Identified Risks to Impartiality
After we have recorded the identified risk to impartiality,, the next step is to analyze its impact.
How to analyze the Identified risk to Impartiality?
Below are some guide questions:
What is the level of impact in relation to laboratory results?
How often does this identified risk occur in the process?
Can this identified risk be ignored?
There are tools that we can use in order to analyze and evaluate the identified risk to impartiality to the confidence of laboratory results.
The standard does not specify any risk assessment tool. And in this regard, I will share only the tool that I know and understand.
The objective of why we perform the analysis is to identify its impact on our process, And from this analysis, we can now evaluate what action or prevention that we can implement. We can either eliminate or at least minimize if elimination is not possible.
Below is the sample analysis tool that I used from Eurolab’s Cook Book no 18. It is a color-coding technique to show the significance and relationship of the Impact versus Probability level.
We can call this the “Impact versus Probability” Assessment tool (see below image).
This will show us that:
The higher the impact and the probability of occurrence require immediate action (orange to red).
If the risk is minimal (yellow), decide if this is an acceptable risk that can be controlled.
If the risk is small (green), where there is no effect on our results, it can be ignored but included in a watchlist for continues monitoring.
