What are the Steps in Ensuring a Definition/Implementation of an Effective Procedure

v9991

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#1
counter question is what are the steps hindering effective definition/implementation of procedure (SOP, system)

Some of the places people/organizations are not aligned... hence ineffectiveness of system/procedures; & this is typical phenomenon in pharma....(yes there are exceptions but then again they are pockets of bright ilghts... not quantified...not qualified... )

What i have noticed is that people tend to see what is minimum requirement...and that is it...!!!

its even worse in case of implementation., most of times, what people tend to focus is on 'mere document'; not effectiveness of it. (this is especially true for new procedures )

+ for old systems...whole emphasis seems to be demonstrating "compliance"... often deemed as having a documented evidence. (focus of compliance is of-late shifting to improvements thanks to FDA focus on trending & CAPA)
 
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C

CGarveyX

#2
Re: What are the Steps in Ensuring a Definition/Implementation of an Effective Proced

I believe that the root of most of the issues that come up have to do with buy-in. Unless you can convince everyone that having a well-documented, accurate set of procedures and work instructions will benefit them, the roadblocks are more likely to remain in place.

I think the common thought is that the documents are there to appease auditors and show that your system conforms to a standard’s requirements. Experienced employees that have been using systems for a long time are less likely to refer to their procedures and work instructions (in my experience). I think the trick is showing that they have to potential to do so much more.

One way to help this is to always use these documents for training. That should at least help to keep them up to date and accurate. Another tip came from a consultant we used. He always made a point of getting us to document our processes with enough detail that we could use it for problem solving or looking for root causes. The idea being that if something goes wrong, we can go back to the spot in the procedures or work instructions where things went wrong and see if it is a system deal. This can help with evaluating effectiveness. If problems keep pointing back to the same step in a procedure or work instruction, then something probably needs to be done about it.

Not quite sure if this is what you are looking for, but hope it helps!
 
B

blairaby

#3
Re: What are the Steps in Ensuring a Definition/Implementation of an Effective Proced

I agree the key requirement is buyin.

Before a document is created or before a review takes place the author needs to complete a stakeholder analysis to ensure that the author consults enough with all including the end users prior to release and also after release.
 

v9991

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#4
Re: What are the Steps in Ensuring a Definition/Implementation of an Effective Proced

exactly, the point is ""extent-commitment-objective/purpose"" of buy-in from stake holders is the point.

-->this has impact while ""defining"" the SOP, by curtailing the intent/extent of guidance; viz., more often than not; procedures only talks about ''plan - do "" (what and how and who and when) parts; ""check & verify ~~~ trend/improvement" are set(left) separately.... and removed from main procedure;

-->i mean, the baggage of delivery/operations kicks in while discussing the adequacy&completeness of a procedure; most frequent question is that this procedure is reviewed/approved auditor, why do we require any further/detailed step to be included in SOP?!!! further down the line, during implementation, miss-alignment gets reflected through amount of energy-time-focus spent on audit-preparations alone!!! we are happy spending that time/efforts over and over again ( i have personally seen numerous times within in a year and over period of year where organization numerous man-days on audit-preparations); but the same amount of enthu-energy isnot found when talking about improvements!!!;

--> btw, training and refresher courses are mandatory but they are just ceremonies(because if they were effective, we would have seen major strides&progress in the QMS of pharma systems as well!!!)

--> incidents/investigations would give you learning; but with above attitude how long could it be sustained is the question. (this is valid obs because, we keep seeing repeat incidents & complaints around!!! )

for good reason, (at-least pharma domain) the level of compliance is driven primarily(mainly) by regulators; ( even in other places, it seems to be seen as satisfaction/discretion of auditor/consultants!!! ) (of course that has also to do with other factors... viz., in auto industry some are more pioneers/conscious...few are meticulous etc.,; btw in pharma also there are pioneering work being done; but thats limited to certain forums; not so much into open domain) & flip side is the regulators are also not uniform there are somethings called as semi/less regulated markets and then there is are hypersensitive(yes there are ICH - PICs but still the individual regulators have differences); similar situations exist in other industries i guess.

*) i personally believe that, the QMS (atleast in pharma domain) has to shift its gear from definition (adequacy - meeting requirements) to --> driving efficiency/RCA-improvements; one of the best ways is to integrate the systems of "Check & Act" along with the system; and also integrate the related/relevant QMS. ( i think integrated-metrics is the way to do; and it gets little extensive, so need to take help of automation!!!)


**) as said earlier, regulators/consultants/auditors have onus of leading the change; (compliance-certification ---> improvement/RCAs/capabilities); This is especially crucial because of current state of affairs and role/influence they have in today's industry.(ref. above section)

***) One might think there are special initiatives 6-sigma; lean; even others target based projects cost-cuttings, inventories, marketing initiatives of customer satisfaction etc., the point is they are almost-always separately triggered-driven-completed. the reason for failure is mostly attributed to implementation team (either management or consultant !!!) (that is other major problem which is making the operations-functions to think that projects are more important (obviously they are focused & delivering improvements) and QMS is just another system hindering the real projects!!!) exactly, there is the opportunity to adopt QMS to drive the better rate of success;
Disadvantage of having these projects being handled separately; is that, they are not sustainable; and they are perceived to be primary focus and QMS gets secondary-minimal- alignment. Agreed that not all can be integrated with QMS; but then i would use same logic such as QMS is supposed to represent what is required; and also (pharma)industry have to come out of its shell which perceives that QMS is only cGMP and/or anything which matter with regulators alone!!!
 
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