12 Days of a Lab Christmas – Day 11

As we head into the silly season we are delighted to present:

The MAS Management Systems 12 Days of a Lab Christmas!

On the eleventh day of Christmas a key supplier informed us of
serious quality issues with their products

This is probably one of the least expected things that could go wrong. First of all, for a supplier to inform you of a problem is pretty rare! But that supplier is actually showing they understand and care about Quality. So now is not necessarily the time to ditch them!

Before you start tearing your hair out, follow these 3 simple steps to work through the problem.

First: Dust off your system for dealing with non-conformances

You may or may not have a documented process. But if you have accreditation to ISO 17025, ISO 15189, or ISO 17020, this is required and now might be a good time to do that.

Work out whether this quality issue is significant to your work. Assign this question to people who should know the answer. Just because you were the person advised of the problem doesn’t mean you’re the best person to understand the significance.

If it is determined to be significant, you should stop further work that is affected by the quality issue, or at the very least, carefully monitor for any problems with your process outputs. Make sure you tell anyone involved in the work that they should be taking these steps to contain any ongoing negative effects.

Second: Impact analysis

Consider any harm or negative effects that may have occurred as a result of the product’s use in your work.

There are a few tools you have to help with this.

You have your risk management system in place. Use that to help understand the impact of the problem.

Believe it or not, something like a measurement uncertainty budget is one of those tools! If the product or material contributes to the MU of your results, input the new data your supplier can give you to work out if this means a change to the MU. If it does, then what is the impact on results sent to your customers?

You can also conduct a desktop audit of previously issued results where the product was in use. Hopefully, if it’s a critical product you have records connecting the use of the product to the performance of testing.

Record the audit. It’s important evidence of the operation of your quality management system. Have it ready to show to the accreditation or certification body, should they stumble across something during an assessment.

Third: Corrective action

Finally, you can get to your corrective action activities!

Remember the steps in this process are:

Root cause analysis – if your problem is significant, you must drill down to find the root cause. In this scenario, it seems that the root cause is actions by the supplier. But is it?
What have you done to contribute to the situation and its effect?
Is there something you could have done to insure yourself against any negative effects?
Did you make use of your risk management process to its full effect?
These are hard questions to face but tackling them is well worth it in the long run. It helps to prevent any future adverse effects and make for a more resilient system.

Corrective Action – develop an action plan to address the root cause and implement corrective or improvement action to avoid repetition. Sometime this takes a team to do. Use all your resources to make the action effective and long-lasting.

Verification – this stage allows you to evaluate if your corrective action had the desired effect. If it did, you can sign off on the issue. If not, you’ll need to re-visit the issue, beginning with the root cause analysis.

Supplier management

One of the requirements for any quality organisation is to evaluate and manage their suppliers. Clauses like those in section 6.6 of ISO 17025 set out the things labs need to do.

As we stated at the start, now might not be the time to stop using that supplier, especially if your options are limited! But that doesn’t mean it ends there.

Now is the time to do the following.

Document the issue in the records associated with the purchasing and supplier management system.
Think about the criteria used for evaluating suppliers and for the acceptance of their products. Are the criteria you’ve set still appropriate? Perhaps as a part of the investigations into significance, you’ve discovered that your criteria are too strict.
Record the outcome of step 2 and make these a routine part of the purchasing process. Update any methods which include acceptance criteria, and processes for verification of externally provided products (or services) to reflect what was found by the episode.

Don’t forget the customer!

As with all problems that crop up in a lab, we always need to consider the effect on the validity of previous results. Make sure you let your customer know if there could have been an adverse impact on the results issued to them. They can then evaluate the risk by the situation. Often there will be no negative impact, and all will be well. They will also probably appreciate the fact you’ve kept them in the loop.

We hope this shows that no problem is insurmountable. And sometimes problems are actually opportunities in disguise.

If you’d like to turn your problems into opportunities and not sure how the magic happens, then that’s where we come in! Get in touch to talk it through.

Remember, as we always say, you don’t have to do this alone!