Written By: Steve Gompertz, Partner
It’s pretty common for Quality Manuals to depict the Quality Management System (QMS) structure as a 4-layer pyramid; typically showing the Quality Manual, Procedures, Work Instructions, and then Records, from top to bottom (Figure 1). Further depicting the flow of the organization’s activities there is usually a high-level flow diagram (the Process Model). Where things start to go wrong is that the activities shown within the Process Model diagram often are not clearly aligned with the pyramid layers, i.e. – are the activities shown established as procedures or work instructions?
The correct answer is supposed to be “neither”. The Process Model is supposed to reflect a system of Processes. How do we know this? Because it’s stated in that portion of the ISO 13485:2016 standard that we usually scroll right past; the Introduction. More specifically, Clause 0.3 is titled, “Process Approach”. This is where the standard establishes its intent for a properly constructed QMS. According to the clause, your QMS is not supposed to be a bunch of disconnected, or loosely connected, Procedures and Work Instructions.
What’s missing is a fifth layer in the pyramid, between the Quality Manual and Procedures; a Process layer, as shown in Figure 2. This is further strengthened by Clause 4.1.2(a) which notes that the Organization shall determine the processes needed for the QMS and shall determine the sequence and interaction of these processes.
While not explicitly stated, there are differences between Processes, Procedures, and Work Instructions. The one place you can see this intended difference is in Figure A of ISO 9000:2015 (Quality Management Systems, Fundamentals and Vocabulary). Figure A.7 shows that Processes are sets of interrelated or interacting activities. Procedures are the specifications for how to carry out an activity or process.
It's interesting to note that the concept of Work Instructions doesn’t appear in any of the standards or regulations, yet every Organization has them. Work Instructions serve to provide a means for prescribing the steps that are performed within an Activity and are therefore a valid layer within the structure.
Going back to architecting the QMS structure, the Quality Manual provides a place to document the high-level Policies and QMS and Organization structure. The Process layer establishes the Activities that occur within each Process, without providing much detail on how they are performed. The Procedure layer consists of documents for each Process Activity which establishes the requirements to be met by the Activity, the Tasks that must be performed, and some detail about how to perform them. Where a Procedure Task must be performed with prescribed detail, a Work Instruction would document the required Steps. Graphically, the relationships look like this:
So, what are the Organization’s Processes? As with all things QMS, it’s mainly up to the Organization to define, but you should start with anywhere the Standard says something like, “The organization shall establish a process for …”. However, each such requirement doesn’t need to be a separate Process document. Again, it’s up to the Organization to decide on the best architecture, but an example might look like this:
Diving deeper into the Product Realization grouping might then look like this:
Beyond meeting the intent of the Standard, there is significant business value to getting this right. Having a clearly laid out process flow for the entire organization reduces the chances for errors, improves cycle time, and reduces the costs of poor quality by providing a roadmap that ensures everyone understands where they fit into picture, who and they interact with, and what documentation is available to guide them.
If all this seems daunting, QRx Partners can guide and support your efforts to establish a more organized and effective QMS. Contact us at Contact@QRxPartners.com or 833-779-7278.