Please, we don't need any more procedures...

Procedures, procedures, procedures!

We need them. If we work in a regulated industry we have rules to follow and we have to show that we’ve got processes in place that are giving us a fighting chance of following them.

Unfortunately, the mere existence of a procedure means diddly-squat, in terms of compliance. And in terms of Quality.?

Procedures are the written evidence of our processes. But they’re not just meant to exist as evidence, they’re also meant to be used to do the actual processes they’ve captured. Right?

Why do these things matter so much?

Here are a few reasons, in random order, because the WHY might be different for different people:

• they increase productivity (The bean counters love this.)
• they result in the consistent use of best practices (Everybody loves this, because it sounds so fancy. And Operations people might love it most because it means that things are done consistently well.)
• they lower cost - because they result in fewer recalls, mistakes, reworks, and crying (Quality people love this. But so does everyone else. And I would hope that the bean counters would be the biggest fans. - If only they realized…sigh…)
• they reduce the chance of a compliance nightmare or safety issue (Quality people jump up and down about this stuff.)

But we’ve got lots and lots of problems with our procedures. Documentation issues come up time and time again on our audits and inspections. Procedures are one part of documentation - logs, forms, records, reports, etc. - always cause issues, but let’s focus on procedures for now.?

I’m talking about Quality Procedures, SOPs, Work Instructions - any procedure-y kind of thing. (They all have slightly different purposes, but for this discussion it doesn’t matter.)

What are some common problems? The recurring themes?

They’re missing?

• maybe the regulation says you need something to address a specific requirement and it just doesn’t exist?
• the regulations are very clear about what needs to be written, reviewed, approved, and controlled

They don’t follow whatever it is your company has decided is the way to do these things

• maybe you’re all supposed to use a certain template or headings
• maybe there’s a company glossary of terms, to help make sure everyone is using their words the same way, and you’re not using it

They’re not written clearly

• maybe they’re too complicated - the words, the sentence structure, etc.
• maybe they’re badly organized and people can’t find what they need to find
• maybe there are a ton of vague or ambiguous words and everyone has to guess what they’re supposed to do
• maybe no one tested it to make sure it worked and was easy to follow

They aren’t controlled

• maybe you’ve got no system for everyone to know which of the 47,000 versions on file is the one they’re supposed to be using
• maybe they cite other documents in them and aren’t updated when those documents are changed
• maybe access to them isn’t properly controlled
• maybe definitions are out of date?

People don’t know how to use them

• maybe no one was trained
• maybe everyone was told to read it and that counted as “trained”
• maybe no one is trained on how to train

Fun, right? So many places where things can go sideways.

?Obviously, there are lots of things we can do to improve the situation.?

We could:

• Make sure we know the regulations and standards and company policies so that we’re doing all the things we’re supposed to be doing from a compliance standpoint
• Make sure we know what the heck the process actually is - oh, maybe the person who does the thing could be involved? Good idea, right?
• Make sure we have involved everyone else who needs to be involved - think it through, get input from everyone who you need to get input from
• Know how things are done at your company (Sorry to state the obvious.)

Now, I know that at some companies there are an insane number of procedures. I have a client who works in Big Pharma and she said they have over a hundred thousand procedures at her company. WHAT?!?!. I almost fell off my chair when I heard that (I come from start-up land and this was shocking.)

Anyway, here’s what I think:?

I think we’d improve things considerably if we add just a few more simple, clear procedures (yes, even in the companies where there are thousands).

I think we need to make sure we have some easy-to-follow, easily accessible, much-talked-about procedures that cover the following:

1. How to Write Procedures
2. How to Control Procedures
3. How to Make Sure Your Procedures Work
4. How to Train People on a Procedure

And I’m the type who would actually name these procedures just like I did above…because if we have to think about what the heck “Optimized Strategic Management for Effective Documentation Compliance” or “Effective Process Implementation Operatives” means we might not realize what the procedure is actually supposed to be used for.?

Do you think something like this would make a difference at your organization?

#medicaldevices #pharma #biotech #SOPs #communication #qualityculture

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For those who are working on expanding their English vocab, here are a few more to add to the pile:

diddly squat - nothing

bean counters - the people paying attention to the money end of things

jump up and down - are excited?

go sideways - something goes wrong, or not according to plan

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I have a group on LI - Building a Quality Culture - Please join if you're interested: https://www.dhirubhai.net/groups/14113382/