ISO9001 in 2021 Week by Week - Week 38 – 8.5.1 Control of production and service provision

This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)

(It is strongly recommended that you purchase a copy of ISO9001:2015  for reference).  And, be sure to do your homework!

8.5.1 Control of production and service provision

Hello everyone!  The great news this week is that we get to open a new chapter in the standard.  We switch gears from external to internal.  Previously we discussed the controls necessary to ensure any external providers do not impact our ability to provide consistent delivery of a quality product/service to the customer.

Now, we have to look inside to see what we must do to put our best foot forward as well.  Like previously discussed with outsourcing, certain information must be available if we are to meet expectations.

“8.5.1  The organization shall production and service provision under controlled conditions.” 

Delivery and post-delivery activities include things such as logistics, shipping, returns, ongoing service such as subscription or auto-delivery, drop shipping, etc.  This opens the playing field to the requirement of having the following information for more than just the manufacturing or transactional service process.

“Controlled conditions shall include, as applicable;

a)  the availability of documented information that defines:

1. The characteristics of the products to be produced, the services to be provided, or the activities to be performed;
2. The results to be achieved;”

 As we attempt to set up our production/service process, this information should have already been defined long ago during 8.2 Requirements for products and services. 

This is where many companies’ quality management systems begin to fragment into tiny pieces.  This one little bullet point, if recognized and dealt with properly can make or break the user friendliness and manageability (in terms of documentation) of the whole ball of wax.  That’s simply my opinion, but as “root causes” go in terms of disappointed ISO9001 quality management system users, this is the most common one I’ve seen.  As we create controls for production/service, there are a multitude of tools available.  We must “define the activities to be performed and the results to be achieved”.  If we choose one best method, a large bulk of the supporting documentation can follow this one pivot point.   Unfortunately, things don’t typically go this way.  Instead, we get document crazy – the documentation gets away from us – and users are frustrated.  Remember to stay process-focused.  After all, your business very likely actually RUNS that way.  Most businesses operate as a series of either parallel or interactive processes.  If they’re tackled this way, instead of fragmented by telling any person at a particular step to “document everything you do”, the process, its risk and its control points become much more obvious.

Many organizations will start this section by using a control plan, which is great to meet the requirements of “define the activities to be performed” and “the results to be achieved”.  But later, additional layers are added such as procedures, work instructions, training documents, and on and on until the number of documents is unmanageable and ultimately the system becomes so cumbersome that users begin to squirrel away their own notes in order to work their production process.  This is a shame and is completely unnecessary.

In every case, I recommend that creators or modifiers of a quality management system consider this one key point first and as a pivot point for their entire system.  If a control plan is to be used – leverage the use of this popular tool to function as your “documented information” (in lieu of a procedure).  It can also work as a work instruction.  It can work dual-purpose as a training document also (assuming training is given in how to use, read and interpret a control plan), which can be converted into a training record as well.  There is no need to create multiple documents which all basically say the same thing.  The core requirements of this clause explain all the controls necessary to create a stable and robust production/service process.  Keep this in mind as other requirements come up – ask yourself if you already have a tool which will work, rather than have a knee-jerk reaction to create more paper.  And if you determine you simply MUST create a related document, be sure to link it.  A disjointed library is not useable.  All the (even well written) documents in the world will not create a successful quality system if they can easily be found and used.  OK – rant over.  Let’s move on.

“b)  the availability and use of suitable monitoring and measuring resources;”

As requirements are identified, and the appropriate controls are put in place, often times these controls include monitoring and measuring devices and methods.  This bullet requires that we have a disciplined and intentional design around our controls and who and what is used to monitor and measure the results.  There are more requirements around measuring later in the standard, but the design of processes and their controls starts the conversation.

“c)  the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met.” 

Again, a simple control plan will automatically include this information.  If you don’t like the looks of a control plan, use any tool you like, but be sure to include this information.

“d)  the use of suitable infrastructure and environment for the operation of processes;” 

Many companies include process setup parameters including maintenance and readiness as a central part of their production and service provision.  For example, there may be a startup process, routine checking and maintenance by the operator, a shutdown process, inspection of area & equipment, 5S checks, etc that may be integral to the whole process itself.

“e)  the appointment of competent persons, including any required qualification;”

We just talked about this last week when dealing with external providers.  We must, of course include this information for our own internal processes as well.  Keeping this linked with training (and avoiding additional documents whenever possible) is a great opportunity to keep our quality system as lean as possible.

“f)  the validation, and periodic revalidation, of the ability to achieve planned results of the process for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement;” 

Processes must be validated and revalidated (and validated again) to ensure acceptable results.  We cannot rely on inspection for quality, and in some cases, inspection is not even possible.  So, validated processes are critical to controlled production/service.

“g)  the implementation of actions to prevent human error;”

This is a very straightforward requirement as it states very clearly that this “shall” be done.  But it also gives the out by saying “as applicable”.  Human error proofing is not possible in every situation.  But, this encourages us to remember to consider the risk in the process and error proof whenever possible.

“h)  the implementation of release, delivery and post-delivery activities.” 

All steps in the process, including release and shipment should be described and controlled.

THIS WEEK’S HOMEWORK

Review your approach to this clause as a whole.  As the bullets tick off above, is your system fragmented or streamlined?  Do you describe these bullets in multiple places?  Ask yourself why?  Is there an opportunity to consolidate?  Are all of the bullets adequately addressed?  Is this documented?  Are you happy with your system?  Next, ask how well controlled the processes actually are and how well they are performing. Are you getting the quality you expect after all the effort you’ve put into your quality system?  Taking this important step can make the difference between a quality system you love only on audit day and a quality system that is part of your organization’s DNA, resulting in a better product and a better customer experience. 

This weekly series is a DIY guide including lots of FREE STUFF like templates, examples and tutorials.  So, SUBSCRIBE today and we’ll keep it coming to your inbox weekly.

Use the form below and download a FREE Control Plan Template.  This is a very simple tool that paints an easy to follow picture of how a process works, the criteria it should meet at each step and the controls at each gateway.  A simple combination of process map and control plan can help you build a lean, yet robust, quality management system. 

Watch this 3-minute video about another great resource to accompany this series.   Get the self-directed, on demand, online learning series  ISO9001 in Plain English, today and you'll get:

• A clear understanding of the requirements of ISO9001:2015
• Proven tips to build a robust quality system that's easy to use
• Ways to reduce documentation and paperwork (yes, really!!)

Each video is about 15 minutes and targets a specific element of ISO9001, (with over 6 hours of total content!).  We translate all the gobbledegoop into Plain English you can understand and leverage the requirements to get maximum VALUE from your quality efforts. 

For a deeper dive into the process side of your quality system, get Tribal Knowledge - The Practical Use of ISO, Lean and Six Sigma Together, a simple guide to UNITE ISO9001, lean and Six Sigma to create a robust quality system with better results.  Read what ASQ American Society for Quality – Quality Progress Magazine  had to say about it. 

We look forward to continuing this YEAR LONG journey with you.  SUBSCRIBE today and the series will come to you weekly to get you off to a great start and your quality system reinvigorated. 

And join me on my journey to always keep improving!