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In the final episode in our ISO/IEC 17025 Nonconformance Webinar Series, we learned from Pam Wright. Pam Wright is the Instructional Design Manager with A2LA WorkPlace Training where her main responsibilities are the design, development and implementation of instruction as well as management of the training department and instructor corps. She formerly worked as the Quality Manager for the American Association for Laboratory Accreditation (A2LA) and continues to support them as a Lead Assessor and International Peer Evaluator for both APAC and IAAC. Ms. Wright has a B.S. degree in Biology from Towson University and is working towards a M.S. degree in Education with a concentration in Online Learning.

The focus of this webinar shifted our focus to section 7.5 of the ISO/IEC 17025 standard which looks at technical records. In this episode, Pam Wright, gives us an overview of the top nonconformities, a refresher on section 8.4, the requirements of section 7.5, and provides us with examples of common nonconformities within the section and tips for avoiding them!

This blog serves as a brief recap of the webinar but I recommend you also check out the full recording! It’s loaded with great details and includes a rich Q&A section with your peers at the end. It’s definitely worth your time!

So, let’s talk about the 10 most common nonconformities.

During the webinar, Pam presented a pie chart showing the 2019/2020 deficiency distribution issued to A2LA accredited laboratories. Section 7.5 on technical records made up over 7% of the total nonconconformaties generated and ranked 9th in the top 10 list of nonconformities. So, though it’s not as common as section 6.4 (equipment record and calibration requirements) or 8.9.2 (management review), it’s definitely worth paying attention to.

Before we get into section 7.5, let’s take a look at section 8.4, specifically clause 8.4.1 which deals with records more generally.

The purpose of creating and maintaining records is to demonstrate and provide evidence that you did what you said you would do. For ISO 17025, records are broken down into two categories: quality records and technical records.

Clause 8.4.1 requires laboratories to perform two critical activities:

  1. Establish records, on a permanent basis, that provide evidence and demonstrate that ISO 17025 requirements are being met.
  2. Retain records that are clear enough to be read now and in the future. These records also need to be consistent with customer and stakeholder requirements.

Pam also gave us an overview of clause 8.4.2 and the actions that have to be taken when it comes to all records in 17025.

Clause 8.4.2 calls for the laboratory to implement necessary controls for a laundry list of actions. This list includes:

  • Labeling records for easy identification;
  • Storing records in an organized way;
  • Protecting records from loss or damage (using passwords, locks, etc);
  • Backing up documents in case of loss (electronic or physical);
  • Archiving obsolete records for historical purposes;
  • Creating systems that allow easy retrieval of documents. Do you have to climb through a storage room or are you using an eQMS?
  • Defining how long records should be kept;
    • Helpful tip! For A2LA purposes, the minimum retention time is the time between assessments which is generally 2 years;
  • Defining the conditions and the process for discarding documents.

On top of all of these, there are additional requirements on technical records in section 7.5.

Now, let’s talk about section 7.5.

In clause 7.5.1, there are a number of actions that have to be completed by the laboratory.

  1. You have to make sure that for each laboratory activity, the technical records contain the results;
  2. You need the records of measurements that took place;
  3. You need to retain data around the measurement uncertainty;
  4. You need to make sure that the technical records allow the laboratory activity to be repeated under conditions as close as possible to the original conditions. In essence, you need to establish a record audit trail.

Technical records need to include things like the date, the ID of the personnel who performed the test, and original observations made in the moment.

Clause 7.5.2 is a little different.

This clause discusses two actions that have to be taken in regards to technical records. You have to make sure that any changes or amendments to technical records can be tracked to a previous version or an original observation. You also need to indicate who is making the alternation and the date it was made. (Pay attention here – this is a new requirement in the ISO 17025:2017 standard).

The most common nonconformity in this clause is the use of an improper amendment. For example, never use Wite-Out to cover over a data point! This is not in conformance with ISO 17025 because you need to be able to show the original piece of data to maintain the audit trail. If doing this manually, the best-practice is to draw a line through the incorrect value and notate who changed it and when.

Why is section 7.5 the 9th most common nonconformity?

In terms of nonconformities within section 7.5, 76% of nonconformities has to do with insufficient information while 24% has to with improper amendment. For those with insufficient information, the nonconformance usually had to do with lack of an audit trail, lack of initials or other personnel ID for staff in each phase of the process, lack of original observation, no MU factors or no measurement results.

One of the many recommendations that Pam provided during the webinar is to ask yourself the following question during your next internal audit:

“If I don’t write this down, can I still demonstrate conformance with ISO 17025?”

If the answer is no, you should add a step to create a record for that area.

When in doubt, write it down!

How can an eQMS help you avoid nonconformances?

One of the biggest challenges in conforming to the ISO 17025 standard is having complete and accurate records. As Karen Arrivillaga, Account Executive at Qualtrax, pointed out in the webinar, the nonconformances always seem to come when the lab is unable to prove that they are following their own processes they’ve put in place. Which makes sense, because there is so much to be tracked! That’s where an automated quality management system, like Qualtrax, creates huge time and energy savings for you and your team. There’s a much higher risk of errors when using a manual system.

In the case that a deficiency has happened, we know that we need to track that nonconformance and that it could potentially lead to a corrective action request. In Qualtrax, you could simply go to our workflow engine and begin the corrective action request workflow. We’ve already divided the process into key steps and created routes between the steps so that everyone on your team is being held accountable. In the webinar, Karen walks you through our best-in-class corrective action workflow and explains step-by-step how this can bring enormous efficiency to your organization. If you’re interested in hearing even more, schedule a demo! She’d be happy to tell you all about it.

This webinar on technical records was the last in our ISO 17025 nonconformance series. If you missed any of the others or would like to watch them again, you can find them all collected here! You can also reach out to us if you have any questions or would like to hear more about the role Qualtrax can play in helping your organization avoid nonconformances and saving time!

Categories: Audits, Compliance Management, Forensic Labs, Quality Managers, Risk

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