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Making a choice of Simple vs Comprehensiveness of Procedure/System of any Process


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while designing a new-process (SOP) or automating the existing Quality system or procedure, for a bigger/larger/diverse teams, which route would you take.
1. small - compact - minimal system... which capture the essense of the process steps, and expect the teams to implement the letter and spirit of minute details! (some times even mean to allowing to capture the details at key steps of the process)
2. comprehensive - detailed - yet flexible system... which might seem to be JUST to capture the individual steps and each role in the process.

for eg., for a incident(deviation) reporting procedure, it could be as simple and minimal as description(with minimal fields to associate with the process/system or product etc.,) -- investigation summary/report-- capa -- approval - implementation/closure.


(incident report - immediate Correction - review) - (investigation&CAPA - review - approval) - (CAPA implemtn- verification - closure) involving multiple roles, and back&forth iteratons possible in the workflow.

clearly, there are pros, & cons of both the routes.

if you take option 1. how do you ensure the participation, involvement, comprehensiveness of the process.
if you take option 2. how do you ensure that process does not drag / delay ( obviously, having all the people for all the deviations at the same time is a challenge!!!) (not that the involvement of all roles/people ensures, but surely its clearer than the option 1!!!)
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Mark Meer

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Interesting topic...

I know it's probably copping out of the question, but I'd have to say some middle ground.

Given that systems are always evolving and approving, it shouldn't matter too much. Whether the system is too simple such that people are missing stuff, or too complicated as to become burdensome, these can always be analyzed and the system modified appropriately later...
Start with something (probably leaning towards the "simple" side), and go from there...


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One comment - designing a process is not the same as creating a SOP. Creating process documents such as procedures would generally be steps 6 or 7 (in the end) of a process design.


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One comment - designing a process is not the same as creating a SOP. Creating process documents such as procedures would generally be steps 6 or 7 (in the end) of a process design.
I Agree...

But how should that process simple!!! comprehensive!!!

I understand the end, it is the implementation which makes difference wrt effectiveness of that process. but how much does the process contributes/enables the effectiveness of outcome, end results...achieving/maintainingg the desired state?
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The variance lies in the people and it's a double-edged sword. Good people will do well with a minimal process, others won't. So first, I'd consider using education and training, as well as SOPs.

In the software industry I've addressed this problem by insisting on a rigid high level procedure (lifecycle we call it, to make it seem more intelligent) that demands a requirements spec, design specs, code, test specs and tests of components and the final systems. Each such phase completes with a mandatory test and inspection - called "quality gates," these are the main control points: if someone has wandered off-piste, they should detect and correct. They balance the costs and benefits of rigidity with those of flexibility.

Within the phases, I've offered additional "guidance" - procedures, guides, templates and the like - that they can use at will, with encouragement to share knowledge.

The guiding principle was to bet on people doing their best and support them with a library of procedures, guides, text books even, that they could choose to use, backed with quality gates at major control points to trap errors.

As an auditor I've often observed something similar in other industries, with more prescriptive approaches when either there's high staff turnover and minimal training budget, or serious health and safety or environmental risks.

Hope this helps
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