4 STEPS TO IMPLEMENT ISO 17025 IMPARTIALITY PROCEDURE

with 14 Comments

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:

  1. Impartiality requirements as per ISO 17025:2017
    1. Understanding Impartiality (terms and definitions)
    2. The risk to Impartiality related clause and requirements
  2. Commitment to impartiality
  3. Impartiality implementation procedure (in 4 steps)
    1. Identification  and monitoring of risk to impartiality 
    2. Analysis and evaluation of Risk to impartiality- risk assessment
    3. Addressing Risk – Eliminate and mitigate risk to impartiality 
    4. Identification on an Ongoing Basis 
      •  monitoring of risk to impartiality – maintaining impartiality
  4. 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:

  1. “The presence of objectivity.”
    1. 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.”
  2. are freedom from conflicts of interest,
  3. Freedom from bias
  4. freedom from prejudice,
  5. neutrality, 
  6. Fairness,
  7. open-mindedness,
  8. even-handedness, 
  9. detachment 
  10. and balance



As per clause 4 of ISO 17025:2017  Standard, below are the General Requirements for Impartiality

  1. Laboratory activities shall be taken impartially structured and manage so as to safeguard impartiality
  2. The management shall be committed to impartiality
  3. The laboratory shall ensure impartiality in all its activities and not allow commercial, financial or other pressures to compromise impartiality.
  4. The laboratory shall Identify risk to impartiality on an on-going basis;
  5. 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.

  1. No Conflict of interest – You are not auditing your own work during the scheduled internal audit
  2. Detachment –Technicians are not involved in marketing where they perform the calibration – 
  3. Freedom from bias – You are not favoring any request that involves falsification of results  
  4. 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:

  1. Including a statement about impartiality in the quality policy which is signed by the management.
  2. Included on the discussions in the management review meeting
  3. 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:

  1. Document Review – as the name implies, we will review all related documents, for example, audit results, contract review, procedures and many more.
  2. 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.
  3. Expert Judgement – this is where our related experience  and understanding of the standards and processes in the laboratory are very helpful
  4. 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:

  1. Company  to personnel relationship
  2. Laboratory activities to personnel relationship
  3. 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:

  1. What is the level of impact in relation to laboratory results?
  2. How often does this identified risk occur in the process?
  3. Can this identified risk be ignored or accepted?

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:

  1. The higher the impact and the probability of occurrence require immediate action (orange to red).
  2. If the risk is minimal (yellow), decide if this is an acceptable risk that can be controlled.
  3. 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.

Impartiality Risk Assessment Tool
Impartiality Risk Assessment Tool (Impact and Probability Matrix)



Addressing the  Risk to Impartiality – Eliminate or Mitigate

Once we have analyzed the risk to impartiality based on the color-coding above ( impact versus probability), it is now time to either eliminate it or minimize its effect.

Minimize in a way that even if the activity of risk is present, we can be assured that it has no significant effect on our laboratory activity results.

We need to demonstrate how we can eliminate or minimize the identified risk to impartiality. At this stage is where our corrective actions or opportunities for improvement process or procedure will be used.

Below are some examples of Measures to address the Risk to Impartiality:

Measures to address risk to impartiality
Measures to address risk to impartiality

Residual Risk

Residual risk is those risks that remain after we addressed the identified risk. For those risks that we cannot eliminate after addressing it we need to perform continues monitoring to ensure that risk is controlled.

Some form of monitoring is to have proper recording or documentation of activity to be reviewed or included in the Internal Audit schedule. See the related process below, read on



The Risk to Impartiality Identification on an On-going Basis 

An on-going basis means that once you have identified the risk to impartiality and finished addressing them, you still need to perform monitoring and analysis in order to ensure that risk to impartiality is properly eliminated or controlled whenever there is a new activity or new changes to laboratory activity.

In addition to the monitoring process, in order to have  a Risk Identification and assessment in an on-going basis,  it is advisable to include the impartiality process on below activities:

  1. Review and analyze all identified risks to impartiality during the management review meeting
  2. Included in the Internal Audit
  3. Performance review


Process Flow Chart

Impartiality Process Flow Chart
The risk to Impartiality Process Flow chart



Conclusion

The risk to Impartiality identification is one of the requirements of ISO 17025:2017 that is mandatory to be implemented. The ease of implementation is by having a system to follow, In short, a Risk  Analysis Impartiality Procedure 

In this post, I have presented the following:

  1. Impartiality requirements as per ISO 17025:2017
    1. Understanding Impartiality (terms and definitions)
    2. The risk to Impartiality related clause and requirements
  2. Commitment to impartiality
  3. Impartiality implementation Procedure
    1. Identification  and monitoring of risk to impartiality 
    2. Analysis and evaluation of Risk to impartiality- risk assessment
    3. Addressing Risk – Eliminate and mitigate risk to impartiality 
    4. Identification on an Ongoing Basis 
      •  monitoring of risk to impartiality – maintaining impartiality
  4. Impartiality Process Flow Chart

This Impartiality Risk assessment procedure is also applicable to Risk and Opportunities process implementation under Clause 8.5. The only difference now is that we will focus on the laboratory activities regarding the risk assessment of the overall operation of the laboratory.

Have you identified Risks to Impartiality that you want to include here, please comment below.

If you liked this post, please share and subscribe.

You can also connect with me in my Facebook page.

Thank you.

Edwin

14 Responses

  1. David
    | Reply

    Great read as always! You’re a big help.

    • edsponce
      | Reply

      Hi David,

      Thank you for reading my post. I appreciate your comment.

      Best regards,
      Edwin

  2. Alice Mosca
    | Reply

    Dear Edwin,

    Thank you for your post, it is a very good approache to one of the pillars of ISO 17025:2017.
    Allow me to disagree with you in two points: if you identify a risk to impartiality you can not ignore it even if it is a small risk. The standard is clear and requires an action to eliminate or mitigate each risk to impartiality identified. For that reason I personally don’t use the risk matrix for impartiality risks.
    Another point is the identification of risks to impartiality on an on going basis. This is not the same as periodically monitoring. If you monitor it on management review or during internal audit you are not doing it on an on going basis. You must be prepared to immediately identify risks to impartiality when they are prone to occurre and not wait until management review or internal audit.

    I hope this comment will contribute somehow to clarify your great post.

    Best regards and wishing you a fantastic 2020!

    • edsponce
      | Reply

      Hi Ms. Alice,

      Good day!

      You are welcome. I appreciate the time for reading my post.

      You are correct and I agree with you.

      An identified risk is still a risk so it needs to be monitored in some way. I believe there are other tools out there that are still best to help us analyze and evaluate in a more simple way.

      Thank you for these additional inputs. The on-going basis for me has a very broad meaning where I only mention a few points.

      Your comments are highly valuable to clarify, I believe not clear to most. I appreciate it very much.

      Thanks and Happy New Year!
      Edwin

  3. vinod kumar
    | Reply

    Great post. Thanks a lot.

    • edsponce
      | Reply

      Hi Vinod,

      You are welcome.
      I am glad you liked it.

      Thanks and regards,
      Edwin

  4. Jollin A Doshi
    | Reply

    Practically speaking..it is difficult to identify on on going process.. practically…best way out identify whenever detected and name it at non conference ..see if capa applicable else consider it as a system lapse on part of cab..the clause is new it takes time to implement it…but over a period of time say around 2 to 3 system cycle of audit most risk will be covered..we cannot practically waste time on just thinking about risk .. identify.analyase implement…Jollin from Jems calibration.

    • edsponce
      | Reply

      Hi Jollin,
      Thank you for reading my post.
      The ‘on-going basis’ is really a challenging part of this process. You are correct, it takes time to understand and fully implement.

      I appreciate the additional inputs.

      Thanks and regards,
      Edwin

  5. Cyra Lynn
    | Reply

    Thank you Sir! It is such a great help to us.

    • edsponce
      | Reply

      Hi Ms. Cyra,
      You are welcome. Thank you for reading my post.

      Thanks and regards,
      Edwin

  6. Kam
    | Reply

    I read so meany posts on this issues, you brought the point home for me. Thank you. Now I know what I need to do for my lab in terms of impartiality issue. Cheers to you.

    • edsponce
      | Reply

      Hi Kam,
      You are welcome. Happy to know that my post has helped you. I appreciate your comment.

      Good luck in solving your impartiality issue.

      Thanks and regards,
      Edwin

  7. Mary Jean
    | Reply

    Hi Edsponce,

    This is great help!

    Regarding the risk, the Owner is the Lab Manager, what would be your action?

    thanks much,
    MJ

    • edsponce
      | Reply

      Hi Mary,
      Thank you.
      About your concern, below is my input.

      Identified risk to impartiality is dependent on its impact or severity and the frequency of occurrence. The identified risk may have no impact or acceptable with regards to the final results of the calibration activity as per the evaluation performed.

      But as an action step, he should be aware of the risk to impartiality that could arise in his position by signing or acknowledging the impartiality agreement.

      He should also be trained regarding the conflict of interest that can be seen in his position and personally declare any conflict of interest that will arise while performing his duty in order to prevent such risk.

      For example, one customer is his relative or his close friend. He should personally declare this situation to limit or monitor his involvement in the project.

      There are still so many possibilities and instances that we need to evaluate regarding this situation. I hope my example answers your concern.

      Thanks for reading my post.

      Best Regards,
      Edwin

Leave a Reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.