The new ISO 17025 puts a bigger emphasis on impartiality and managing conflicts of interest than the previous standard. This is to address an issue that can be particularly problematic in competitive industries such as construction.
In some industries there are practices that aren’t ideal for maintaining impartiality and it can be a difficult environment for testers. In the construction industry the laboratory is at the end of a long chain of sub-contractors and regulations and is often squeezed on price. There’s pressure from clients, overbearing contractors or even internal management for the “right” test results or pressure to collect samples from one location only. Similar pressures can exist in other sectors too.
Expect tough questions
The tougher requirements regarding impartiality mean you should now expect NATA to ask you about these issues at assessments. If you’re like many lab managers, this is a difficult subject to talk about, and just assuming that your staff “wouldn’t dare” will not cut it. How do you design an effective policy that will address the real risks due to conflicts of interest and undue influence in your organisation?
Situations of undue influence, or conflicts of interest can lead to test results being either intentionally or unintentionally incorrect! If this is discovered after the results have been issued, it could not only be devastating to your business but it could also potentially have criminal implications.
So, what can be done to protect the reputation and integrity of your business? After all, reliability of test results is likely to be central to your business model.
Know the warning signs
Identify what situations could arise in your organisation and write them down. Think broadly. While many situations may seem unlikely it is still useful to get them out there. There are many different situations that can lead to compromised testing.
Here are just a few:
- Testing for compliance on an in-house product – compliance, especially if the tester also has production responsibilities?
- Getting on site and being given a limited available area for testing, or an overbearing site manager who just insists testing is done at a specific location.
- Being pressured to give a pass result or repeat the test until you get a pass result.
- Conflicts of interest due to shareholdings, family relationships, second jobs, etc.
- Under-pricing jobs.
- Details in contracts that present a risk to your laboratory such as: site selection; financial penalties if testing causes delays; methods specified that do not match the materials to be tested.
- Over – testing to the extent that the tests staff are doing literally have no significance.
- Media interest in a project or product.
Any of these issues, combined with self-interest (let’s face it, we all want to cover our own backsides) or an over-developed sense of helpfulness could lead to someone being tempted to alter or ignore certain test results. But a lot can be done to protect your lab from this scenario. Read on for a step-by-step approach to reducing or eliminating risks to impartiality. (You can also get in touch to find out how we can help).
6 ways to reduce risks to impartiality
Removing the possibility for results to be changed or left out is a complex task that may require a number of measures to be put in place, such as the following:
- Processes to ensure that all samples are individually logged and sample numbers cannot be reused – e.g. bar-coded sample labels.
- Direct capture of test data in the lab – newer balances and load cells can be hooked up to a computer and directly record readings, also eliminating the risk of transcription errors.
- Logging field data directly into the laboratory information system.
- Automation of testing – explore any possibilities, as they will likely improve your process efficiencies at the same time.
These steps don’t need to involve expensive software packages. An in-house system that captures the on-site or lab data and stores this in a secure way can also be an option. Don’t forget to make sure the data storage is secure and that there is an audit trail for any changes made.
Are there other technical advances in equipment that would allow for further automation that the industry could look at? Can your laboratory be a leader in introducing this?
2. Quality Culture
This comes from Top Management. Instilling a culture of openness, honesty and integrity goes a long way towards protecting your company’s reputation. These values need to be lived and breathed through the organisation at all levels.
Start with your induction process and continue to emphasise your values throughout a staff member’s time with your company. Make sure they know that they can speak up if they don’t feel something is right. Talking about recent incidents or problems at regular meetings is a useful way to remind your staff that they have your support.
Your quality system, which should be seamlessly integrated with the day-to-day work, is crucial to developing a culture of commitment to quality best-practice. Staff should know to look up your organisation’s methods or procedures when they’re not sure what to do. This helps develop a “this is the way we do it here” culture. It also empowers staff as there is a clear process in place if they feel pressured to change results, or test only at a specific location. Who should they report this to? When should they stop testing and leave the site? Make sure your staff learn about these policies when they join your company and design opportunities to revisit the policies on a regular basis.
3. Checking data & reports
An independent review of results introduces a level of impartiality as well as the benefits of a fresh set of eyes for errors. If work is being done remotely on a site lab, introducing back-to-base reporting will reduce any undue pressure on the technicians on-site.
Where possible, automated checks can include a comparison against expected results for that type of sample and previous results.
4. Managing Conflicts of Interest
Review the structure and reporting lines: look for potential conflicts of interest (such as results being used within your company). This can be an issue for production-related organisations and those involved in design engineering. Where possible, remove direct reporting lines. For instance,the laboratory technician or manager should not report directly to the Production Manager or Design Engineer.
Potential conflicts of interest related to external relationships should be declared upon employment and confirmed again on a regular basis. (This particularly applies for company directors). Build any such disclaimers into your induction process. Some organisations do this annually, in conjunction with Management Review or performance management.
5. Contract review
Technical review of contracts is critical in industries where pressure may be applied to get favorable results. Clients may want to minimise testing costs as they are seen as an overhead. Checking the technical, as well as financial details of the contract will help make sure you are not left out of pocket or pressured to complete inadequate testing due to time or financial constraints. If a client insists on an inadequate testing regime, it might be time to re-consider whether you really need to work with that client.
6. Training and education
Make sure you and your staff are well-versed in the critical importance of the test results. What happens if a structure fails and it is found that testing was not accurate? What if your product gets released and is found to be non-compliant? The implications of failure at this late stage are massive! If you identify and deal with a compromised result immediately, any short-term pain from dealing with someone who doesn’t want the true result is no matter compared to the long-term consequences for your business.
Training also needs to include how to confirm that the test being done has worked correctly and what results to expect for different types of materials.
Get extra help
We have been providing guidance on dealing with impartiality and other changes to ISO 17025 to our clients since the changes came in. We can give you peace of mind that you are doing what you need to without reinventing the wheel or making unnecessary wholesale changes. If you need this kind of help, get more details here or contact us via our contact page.