ISO 9001:2015 – Newsletter – Issue 70

Issue 70 – Trace Audits

ISO 9001:2015…

Trace auditing, ever tried it?

I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with direction on where to aim the content of these publications.  The topic I would like to discuss in this Newsletter is in regards to performing “trace” audits, which really is a great way to audit the most critical processes within your QMS.

In my last Newsletter (ISO 9001:2015 Newsletter Issue 69) we discussed the topic of the added words “…and services” to the ISO 9001:2015 Standard, now in this Newsletter we will discuss what “trace” audits involve and how they can be a very effective approach for re-energizing your internal audits (…and your auditors!).

I should begin by explaining what is involved with “trace” auditing.  It really may not be a new approach for many auditors, or perhaps some people didn’t even know it had a name.  At a high-level, an ISO 9001(Quality) trace audit is typically conducted by going to the Shipping dock and grabbing a Customer shipment that is about to go out the doors.  You then “trace” this Customer shipment all the way back, through each of the Departments that touched this Customer Order, ending with the original Order that was received.  Along the way you would verify that all Customer requirements were met (collecting the applicable records as proof of this).  This is called a “trace backwards” audit since you end up swimming upstream to follow the flow of activities.  Conversely, a “trace forward” audit starts in the Sales or Customer Service Department, where a recent Order is selected that has already been shipped out, and even better if it has been received by the Customer (in case any issues arise upon delivery).  Both forward and backward trace audits are equally effective however just make sure that the Order is randomly selected, and you may want to pick more than one Order to follow, for better results.

Many auditors tend to like “trace forward” audits because it feels like a more natural flow to the sequence of Departments you visit.  An easy way to begin is to go down to the Shipping Department and randomly select a few different Customer shipments that are going out that day.  Then take samples of the actual product that is being shipped out, or if that isn’t feasible then perhaps actual pictures of the product going to the Customer.  Now head to the Customer Service Department with all the information you recorded from those Customer shipments and locate the original Orders (before any amendments or changes were made, if any).  At this point you can dive in and ask questions about all of the information contained within those Orders, as well as any amendments that were subsequently made.  In addition, I would ask the person in Customer Service where the Order then goes or who is the next person (or persons) that will look at it.  To summarize the rest of this approach you would now simply follow the Order through whatever Departments it travels.  You can start each interview by simply placing the product sample you obtained (or a printout of the picture you took) on their desk or table and just ask them what they did to make that final product happen.  This “tracing of the path” taken by the Order should ensure that all of the key processes are audited, all the way to the Shipping docks.

One of the biggest benefits of using this approach is that it gets the conversation laser-focused for both the auditee and the auditor.  You will need to act a bit like a detective in this approach, so get curious and discover all the processes that the Order can travel to, or can impact.  You may also have to get creative with those Departments that can’t see how they connect to the Customer Order (like all of the supporting processes in your QMS).  For example, what does the Maintenance Department have to do with the Order in your hand?   …perhaps, ask to look at the maintenance activities that have been done on the equipment that made contact with the product in your Customer Order.  Human Resources?  …ask them to show you the records of all those people who directly touched the particular Customer Order you are investigating.  Purchasing?  …that can be a challenge if goods are purchased in large lots and not just for one Customer Order.  In this case, ask them during what time-frame would the purchases have had to be made in order to make it into your Customer Order, and then based on that, look at what was ordered/received during those time frames to ensure purchase order requirements were met.

It may be a bit bumpy the first time you attempt a trace audit but keep at it because the overwhelming feedback I’ve received is that auditors really like this approach because it makes it more interesting and understandable to them.  Management tends to like it because audit findings are clearly connected to their Customers.  I have had the opportunity to conduct what I call combination audits, where I provide hands-on training while at the same time conducting an actual audit.  This can be helpful when introducing a new approach like “trace auditing”.

Keeping your pool of internal auditors motivated year after year is a big challenge for most QMS Reps.  Introducing “trace auditing” might be one way to breathe life back into your internal audit program.  On a final note, I’ve also been involved in conducting trace audits alongside company internal auditors, both for ISO 14001 (Environmental) and ISO 45001 (Health & Safety), and they work equally well in those areas (…you just need to tweak your approach).

Be sure to watch for our next Newsletter issue where I will be answering some of the questions that I get from Readers of my Newsletters about how to implement the requirements of ISO 9001:2015 in a specific and practical way, that will also help improve business performance…