Are SOP’s Your Problem?

September 23rd, 2011 by

I am intrigued by certain webinar companies that appear to spend a fortune on advertising.  You’ve seen their emails and half page ads. They go like this.

What’s the one thing that you can control that is a disaster waiting to happen?  Those piles  of SOP’s fresh off the press that nobody knows what to do with.  Bullet proof your procedures.

You’ve seen the adverts. If only life were that simple.

Actually, writing SOP’s is a relatively easy job if you go about it the right way.

Rolling them out is also simple, again if you do it the right way.  We will talk about these two parts later.

It’s not as if perfect SOP’s are needed and that rolling them out must be done perfectly.

I have audited organisations that had pretty poor but acceptable SOP’s with training programs that are uninspiring and yet these organisation operate in compliance.  Are they efficient  – NO?  Do you want to use their SOP’s and training programs – NO?  But they work and the companies stay out of trouble.

Actually the 800-pound gorilla in the room is really management involvement and support for the principles of compliance which includes following SOP’s and actively training staff.

How can you detect this problem?  It is often detected by looking at regulatory citations and/or audit findings.  Look for those observations that are made with CAPA’s that never seem to prevent recurrences.  Look for repeat observations.  Now look at the CAPA’s.  How many call for a rewrite of one or more SOP’s?  How many call for retraining?

As I always say in my class, if SOP rewrite was the right solution, how come we are so bad at doing it that we have to keep rewriting them?   Time and time again. And the problem does not go away.  Are these rewrites so bad or are we tying to correct the wrong thing?

If training and its roll out was the key issue, how many times do you retrain Bill on the procedure and he just does not seem to get it, before you say that there must be another issue here?

At some point, step back and ask the question, how come these rewrites and retraining do not solve the problem?  The answer is closer than you think.  It is the culture in your organisation.  It is a difficult message to deliver and to receive.  But, as my father used to say, understanding you have a problem is half way to solving it.

Do you allow non-compliance with your SOP’s?  Are they optional in your programs?

The answer to all these issues is to do the following:

1.) Before you write an SOP or review it for rewrite, ask the question of whether the effort is worth your time.  Is there an SOP already in place?  If not, do you really need another?  Only then consider rewriting or producing an SOP.

2.) Make sure you get subject matter experts involved in the writing or at least defining content.

3.) Make sure all stakeholders are involved in reviewing the draft SOP.  Does that mean they all approve it?  NO.  There is an owner and QA who need to approve an SOP.  Perhaps 1 or 2 others, but rarely more, are required.  Too many approvers mean things get log jammed.

4.)  Communicate the new SOP before it goes live so that involved parties can assess and train as appropriate.

5.)   Training does not have to be complicated.  It may mean simply reading and  acknowledging you understand it.

6.)  Give the organisation enough time between issuance and go live.

7.)  Document all activities.

Now the biggy.  Make following SOP’s a requirement for continued employment.  Follow them yourself.  Nothing spells disaster more than a boss that is above SOP’s.  If you do not set an example for following them, you are setting an example that they are optional.

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