Creation of SOP for completion of forms

[Dazzur]

Good Morning all,

I'm very new to the world of Quality and have recently worked as a Quality Controller but have now moved into a Role as Quality Assurance Assistant thus dealing with ISO and the companies QMS.

I have how ever, been tasked with creating Standard Operating Procedures which guide the completion of several forms that are used throughout the design engineering process that the company utilizes.
The problem is that the forms themselves are extremely basic, a few consisting of only a few required entries, and practically explain themselves, I fail to see how or why a SOP should be created to compliment these. Unfortunately all management is away from the business at the moment so I literally have nobody to ask about this.

I'm asking I suppose, if this is a pointless exercise? And should I challenge management about this?
Thank you for any replies.

 

[Tagin]

I suppose the first question is: why does mgmt think that an SOP would be beneficial/needed/required?

For example, I could imagine situations where people know how to fill out the form fields but they don't always use the same date format, or they don't use agreed-upon acronyms, or they don't put the completed form where it needs to go, etc.

In such a case, the SOP could be more of a training doc and also a way to get consistency in the form data and form usage.

Or, perhaps they had an audit finding about forms filled out improperly/inadequately and so they proposed creating an SOP just to satisfy the auditor as a corrective action.

Without knowing 'why', its hard to tell the benefit would be.

 

[Dazzur]

I suppose the first question is: why does mgmt think that an SOP would be beneficial/needed/required?

For example, I could imagine situations where people know how to fill out the form fields but they don't always use the same date format, or they don't use agreed-upon acronyms, or they don't put the completed form where it needs to go, etc.

In such a case, the SOP could be more of a training doc and also a way to get consistency in the form data and form usage.

Or, perhaps they had an audit finding about forms filled out improperly/inadequately and so they proposed creating an SOP just to satisfy the auditor as a corrective action.

Without knowing 'why', its hard to tell the benefit would be.

Thanks for your input, you're right, It seems I've made the most basic of oversights and completely overlooked the fact that it will bring consistency to the form completion and submittal process. I'll remember to put to them 'why' upon their return, thanks once again.

 

[FRA 2 FDA]

If Tagin's guess is correct, it sounds like what you might need is a "record and data control" SOP. This should govern filling out all forms/ QSR documents in general and should specify

• Acceptable ink color/type
• Acceptable date format
• N/A-ing blank fields
• Fill out forms real-time
• etc

Alternatively, you may just need to clean up the troublesome forms and make them more user friendly. Forgotten fields constantly left blank? Maybe that field is unnecessary and should be removed. People always putting the wrong info somewhere? Maybe it's not clear what it is asking for. Pertinent info often missing? Maybe the form doesn't ask for it specifically enough. Find the patterns or ask the people who have to use them the most.

 

[Tidge]

It is common across a variety of industries to establish "acceptable documentation practices". I've never worked at a company that formally established the rules via an SOP, but rather delivered the training in a uniform manner. Establishing an actual SOP simply makes it more likely that you will end up non-conformances in documentation practices, which in turn will lead to endless cycles of correcting records with even more updates which would further increase the likelihood of non-conforming documentation practices... with the end result that records will become incredibly difficult to understand.

 

[Tidge]