What is meant by impartiality in a laboratory?
Posted by Cathy Wylie on
There are new requirements in ISO/IEC 17025:2017 related to impartiality. Section 4.1 covers impartiality, including the requirements for laboratory activities to be undertaken impartially; structured and managed to safeguard impartiality, as well as the requirement to identify risks to impartiality. But what does being impartial mean?
The definition in ISO/IEC 17025:2017 is "presence of objectivity" and is further clarified in a note saying, "Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory."
In the context of laboratory testing, being impartial includes conducting laboratory activities without bias. Lab results cannot be influenced, or have the appearance of being influenced by any relationships the laboratory or the people involved in laboratory activities may have with the client. Laboratory activities also cannot be influenced by any undue pressure being put on the people involved in conducting those laboratory activities.
Risks to impartiality can come from within the laboratory itself. For example, managers putting pressure on technicians to break from testing procedures to get better turn around time, or to overlook adverse results that will upset a client. Undue pressure would also include providing financial incentives for the number of tests conducted, or the results of tests.
There can also be external risks to impartiality. When looking for external risks, there are multiple possibilities that could cause bias, including:
- business relationships between the laboratory and the client;
- family or personal relationships between people in the laboratory who will be involved in laboratory activities and the client;
- financial interests, such as ownership in a client company, or in a venture related to the test results. For example, a laboratory technician has part ownership in a land development. The engineering company is testing the soil for the site prior to getting permits for the development.
Simply having a relationship with a client does not mean there is a risk of impartiality, however, the laboratory is required to identify the potential risks and then demonstrate that the risk has been eliminated or minimized.
For more information on the requirements of ISO/IEC 17025:2017 and how they affect your laboratory management system, click here to check out CALA's courses on the revised standard.
Responding to Brian
Please review CALA’s impartiality policy on our website at the following page:
https://www.cala.ca/wp-content/uploads/A138-Impartiality-Policy.pdf
It’s not written specifically for a laboratory but you can modify as you see fit.
Thank you,
Belen
I kindly need an example of IMPARTIALITY POLICY.
Responding to Susila de Silva
1. please explain possible issues related to conflict of interest if the laboratory belongs to a large company with different departments.
Hi Susila:
The potential issues when a laboratory belongs to a large company with different departments arise out of reporting results and concerns with impartiality. If the structure of the organization is set up so the laboratory reports to the manager of the same department that they provide test results to, there is a concern about undue influence.
For example, the laboratory reports up to the department responsible for Product X. The laboratory tests for the presence of a contaminant in Product X. If the contaminant is detected in quantities greater than 2 parts per 1000, the corresponding batch of the product must be dumped. The laboratory finds the contaminant and the test results show there is 2.6 parts per 1000. The laboratory manager contacts their boss (the manager responsible for Product X). The boss responds that dumping the batch will cost the company a million dollars. He demands that the laboratory manager report the contaminant as under 2 parts per 1000, otherwise the laboratory manager’s job could be in jeopardy.
2. what is the meaning of "integrity of the management system
The integrity of the management system means that the system is set up so that the results from testing are correct and are the results that are reported. From the testing side, the system is set up so tests are validated or verified to show that the laboratory can achieve the required results. From the rest of the management system, test results as found during testing are the test results that are reported. There are no issues with impartiality, undue influence, etc. that allow test results to be altered.
I hope that helps.
Cathy
1. please explain possible issues related to conflict of interest if the laboratory belongs to a large company with different departments.
2. what is the meaning of "integrity of the management system
Thank you
Hi again,
I have a second question related to the new integrity clauses, especially 4.1.4:
The laboratory shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relationship, or from the relationships of its personnel. However, such relationships do not necessarily present a laboratory with a risk to impartiality.
Our parent organization’s values and ethics code includes a requirement that employees regularly review their obligations under the code and report any real or apparent conflicts of interest to the Departmental integrity office through a confidential reporting mechanism. We (our lab) don’t have any records that this review is done (and being confidential, we couldn’t access them anyway). Is it enough that this requirement is in our organization’s policies, or will our lab need to do more to demonstrate conformance to this part of the standard (e.g. have our staff annually sign a form acknowledging that they understand their obligations under the values and ethics code and regularly review their conformance to it)?
Thanks again for your help!
Jeff