Errors & Omissions in Creating QMS Procedures

[TacitBlue]

Is there a best practice to ensure managers do not leave out important steps when creating QMS procedures?

 

[Randy]

Yep, don't use managers or anyone else if they aren't SME's on the topic.

 

[Jim Wynne]

In addition to Randy's advice, being an SME is not necessarily a good indication that a person is competent in writing QMS documentation, but it's the place to start. Someone who understands the processes involved needs to at least review the documents before they're released.

 

[John Broomfield]

Is there a best practice to ensure managers do not leave out important steps when creating QMS procedures?

The process owner (not necessarily a supervisor or manager) engages members of the process team in reviewing their documented procedure for as-is accuracy. That way the procedures are not created as works of fiction.

Procedures for newly designed processes are accurately documented to the extent necessary for their effectiveness in planning, training and operation. But always be ready to make any required changes.

 

[ChrisM]

Is there a best practice to ensure managers do not leave out important steps when creating QMS procedures?

Yes, review by a SME. This applies not just to QMS procedures but any "official" procedure (or instruction) written by anybody for any purpose. Always have it independently reviewed because the more you are familiar with the "process", the more likely you are to leave something out when documenting it due to over-familiarity. It's one reason why it is recommended that product instructions should be written by a "non-technically competent" person

 

[John Predmore]

I agree someone knowledgeable should write down the steps of the procedure as well as inputs, outputs, criteria for acceptance, and any caveats. Maybe someone else formats and edits for readability.

Many times, the real value of a procedure is to train a new person, or guide a person who does not perform the procedure very often (perhaps a fill-in substitute in the case of vacation or other absence). If that is how the procedure will be used, a best practice would be to select such a person, knowledgeable but otherwise uninvolved in writing the procedure, who then attempts to follow the about-to-be-released procedure in a simulated or real life scenario.

 

[Zero_yield]

People have talked about several piece of this, but the best procedures generally have the input from:

-At least one technical expert on the process. Someone who knows why the process works.
-At least one hands-on expert on the process. Someone who knows the nuts and bolts of how the process actually works in practice.
-At least one compliance / quality person. Someone who knows what the regulations say about how the process is supposed to be done and/or is familiar with the problems that often crop up from the process.
-At least one person familiar with the process as a whole. Someone who understands why the inputs are the way they are and what processes are depending on the outputs from the operation.
-At least one person good at writing human-readable procedures.

One person can potentially cover multiple of the above.

Definitely agree with the suggestions above to try training someone who doesn't currently understand the process using the WIP procedure.

And of course, the last pieces are continuous improvement + deviation management. No one ever gets it perfect the first time. Even if you do magically write the perfect procedure, you'll eventually need to change it. Keep making corrections and clarifications as you find issues with current procedures.

 

[Ed Panek]

You know how employees mark notes on official QMS SOPs? This is frustrating but its also a source of improvement. If you find a marked-up SOP in production with notes on it about the procedure, use those notes to release a new procedure if they are factually correct -verify with author.

 

[Zero_yield]

You know how employees mark notes on official QMS SOPs? This is frustrating but its also a source of improvement. If you find a marked-up SOP in production with notes on it about the procedure, use those notes to release a new procedure if they are factually correct -verify with author.

And if they're hiding their marked-up ones too well, take them off the floor, give them a copy of the current procedure, a red pen, and some time, and let them go to town.

 

[Jim Wynne]

It's one reason why it is recommended that product instructions should be written by a "non-technically competent" person

Recommended by whom?