Audit

Recently, in my street, a gas company was relining all the gas pipes under the road, and to each house. There was a safety problem. And it needed them to turn off gas supply to each house one by one as they worked on each of the delivery pipes. Unfortunately, the method of communication of when your gas needed to be turned off was by knocking on your door and talking to you. Perhaps during Covid lockdowns, this worked OK. But not now – they kept missing me, either because I was out or because I was on a work video conference. This led to frustrations on both sides and when they eventually got hold of me, they complained at how difficult I was to contact. I asked whether anyone had considered using a phone or perhaps dropping a message through the letterbox. “That’s a good suggestion!” the workman said. I pondered this for a while. This is a national company and they do this all the time. This “problem” must have come up before, surely? Why didn’t they have a standard process for contacting householders? They know all the addresses after all.

A really challenging area in process improvement is how to make changes stick? Processes invariably rely somewhere on people. And people get used to doing things the way they have always done them. So, to change that takes effort – change management. But after the improvement project is finished, what if people go back to doing things the way they always did? When thinking about the “Control” part of process improvement, you have to think carefully about how you can ensure the process changes stay in place. And how those responsible can get an early signal if they do not. If you don’t do this, the improvement may gradually be lost.

As I was leaving the house later that day, I bumped into the same workman. He told me to give them a call as soon as I was back so I could get the gas turned on again. He gave me a card with the phone number to call. The phone number was on a card which was designed to be dropped through someone’s letterbox if they were not at home. It had a space to enter the start and end date of the work and a phone number to contact. He had not thought to use it for its actual purpose! Presumably, at some point, someone had made a process improvement and introduced these cards, but the change had not stuck.

You might be wondering, in this example, how you could make sure the changes are permanent. Well, you could ask residents about the service and monitor the responses for the original issue repeating. You could audit the process. And you could monitor how many cards are reordered to give a signal as to whether they are being used at the expected rate.

Any changes you introduce to a process need to be effective. But if they work, you also want to make them permanent. Thinking about how you can make those changes stick is an important part of any process improvement project.

Image – Pavel Danilyuk, pexels.com

It has always intrigued me, this fear of the auditor. Note that I am separating out auditor from (regulatory) inspector here. Our industry has had an over reliance on auditing for quality rather than on building our processes to ensure quality right the first time. The Quality Management section of ICH E6 (R2) is a much needed change in approach. And this has been enhanced by the ICH E8 (R1) (draft) “Quality should rely on good design and its execution rather than overreliance on retrospective document checking, monitoring, auditing or inspection”. The fear of the auditor has led to some very odd approaches.

Trial Master File (TMF) is a case in point. I seem to have become involved with TMF issues and improving TMF processes a number of times in CROs and more recently have helped facilitate the Metrics Champion Consortium TMF Metrics Work Group. The idea of an inspection ready TMF at all times comes around fairly often. But to me, that misses the point. An inspection ready (or audit ready) TMF is a by-product of the TMF processes working well – not an aim in itself. We should be asking – what is the TMF for? The TMF is to help in the running of the trial (as well as to document it to be able to demonstrate processes, GCP etc were followed). It should not be an archive gathering dust until an audit or inspection is announced when a mad panic ensues to make sure the TMF is inspection ready. It should be being used all the time – a fundamental source of information for the study team. Used this way, gaps, misfiles etc will be noticed and corrected on an ongoing basis. If the TMF is being used correctly, there shouldn’t be significant audit findings. Of course, process and monitoring (via metrics) need to be set up around this to make sure it works. This is process thinking.

And then there are those processes that I expect we have all come across. No-one quite understands why there are so many convoluted steps. Then you discover that at some point in the past there was an audit and to close the audit finding (or CAPA), additional steps were added. No-one knows the point of the additional steps any more but they are sure they must be needed. One example I have seen was of a large quantity of documents being photo-copied prior to sending to another department. This was done because documents had got lost on one occasion and an audit had discovered this. So now someone spent 20% of their day photocopying documents in case they got lost in transit. Not a good use of time and not good for the environment. Better to redesign the process and then consider the risk. How often do documents get lost en route? Why? What is the consequence? Are some more critical than others? Etc. Adding the additional step to the process due to an audit finding was the easiest thing to do (like adding a QC step). But it was the least efficient response.

I wonder if part of the issue is that some auditors appear to push their own solution too hard. The process owner is the person that understand the process best. It is their responsibility to demonstrate they understand the audit findings, to challenge where necessary, and to argue for the actions they think will address the real issues. They should focus on the ‘why’ of the process.

Audit findings can be used to guide you in improving the process to take out risk and make it more efficient. Root cause analysis, of course, can help you with the why for particular parts of the process. And again, understanding the why helps you to determine much better actions to help prevent recurrence of issues.

Audits take time, and we would rather be focusing on the real work. But they also provide a valuable perspective from outside our organisation. We should welcome audits and use the input provided by people who are neutral to our processes to help us think, understand the why and make improvements in quality and efficiency. Let’s welcome the auditor!

Image: Pixabay

Category: Audit

Knock, Knock! Who’s There?

Oh No – Not Another Audit!