Re: For Review: Quality Manual - Process Interactions - Two part process overview map
Excellent job, one of the best I have seen.
What I found helps (with support from our notified body) is to split the charts out into 3 tiers of detail. This helps show the QMS main processes, supporting processes and interactions between them. Ensure methods on how to monitor, measure and analyse these processes are part of the integrated approach.
1. Develop a single systemic flowchart for the QMS as a whole. This is to show how the processes are interrelated and integrated. You have done an excellent job on that. Be clear to identify which processes are main processes and which are secondary\support processes. This chart must be contained in the Quality Manual.
The great thing with ISO is that is allows you to pick which processes are your 'main' processes. Therefore you could have 3 main processes and downgrade the other processes as 'support'. For example CAPA proces could be a main process or a support.
Note: Don't forget that some 'systemic' processes (which I would recommend making into secondary processes) may need to be referenced in more than one place in your chart e.g. risk management is throughout the product realisation process (so may need to link to a number of your main processes).
2. Develop one flowchart for each main process and use it to describe how it interacts with other processes using input-output arrows. This set of flow charts will describe how the processes interact. This chart could be either in the Quality Manual or governing SOP, as it is systemic e.g. may show how Internal Auditing (if you pick IQA as a main process) interacts with CAPA and management review. It is only a minor tweak to the single systemic chart above.
3. Develop one flowchart for each main process (e.g. purchasing) and use it to describe how the process should be performed. This set of flowcharts will make up the procedures that control how the process should be performed. I would normally have this chart in the main\corporate guiding SOP.
I find doing tier 2 and tier 3 charts adds most value to our organisation. It helps identify gaps and makes your processes more robust. For example when I did a tchart for CAPA I had risk management as an output of CAPA as well as an input to CAPA. But my procedure did not have risk management as an input to CAPA.
We have been asked to do tier charts only for our 'main' processes. But have found tier 3 charts so useful, that we are applying them to secondard processes as well.