How do you handle missing information? People seem to "forget" to enter information

markl368

Involved In Discussions
Re: How do you handle missing information? People seem to "forget" to enter informati

We're a medical device manufacturer and this is an issue for us because we must assure all paperwork is completed properly before releasing a product. We did the following (all mentioned in previous posts) and it worked:
1. We reviewed our paperwork and found unnecessary redundancies- we revised the paperwork.
2. Where we were using automated data systems (validated, or course), we made sure all entries were required fields. The page couldn't be saved in the system unless all required data was entered/signed.
3. We set an expectation of completion for written paperwork. We then held meetings to outline our simplification and elimination of non-value adding work. We let people know that accurate completion of paperwork is just as important a job function as being on time to the job. After that, incomplete paperwork was returned to the supervisor who would counsel folks about missing information and record incidents. If a certain number of incidents occur, this results in a written observation, and discipline progressively follows from there.

It worked great and since we were careful to work out the problems first and then explain the process, there was hardly any grumbling about things.
 
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Wes Bucey

Quite Involved in Discussions
Re: How do you handle missing information? People seem to "forget" to enter informati

We're a medical device manufacturer and this is an issue for us because we must assure all paperwork is completed properly before releasing a product. We did the following (all mentioned in previous posts) and it worked:
1. We reviewed our paperwork and found unnecessary redundancies- we revised the paperwork.
2. Where we were using automated data systems (validated, or course), we made sure all entries were required fields. The page couldn't be saved in the system unless all required data was entered/signed.
3. We set an expectation of completion for written paperwork. We then held meetings to outline our simplification and elimination of non-value adding work. We let people know that accurate completion of paperwork is just as important a job function as being on time to the job. After that, incomplete paperwork was returned to the supervisor who would counsel folks about missing information and record incidents. If a certain number of incidents occur, this results in a written observation, and discipline progressively follows from there.

It worked great and since we were careful to work out the problems first and then explain the process, there was hardly any grumbling about things.
That's terrific! To paraphrase the folks in the old "A Team" TV show, "I love it when a plan comes together!"
 
K

KarenKH

Re: How do you handle missing information? People seem to "forget" to enter informati

Hello all,
I take it back just like everyone else does, and let them know that if its not filled out each time that I stop bringing it back but let them come to me and fill it out and ask why its so hard for certain aspects to be filled out and change it if it needs changing. My question is it ok to let someone initial and date the top box then line down to the last box. Will an auditor find this ok or unexceptable? I get differ answers from people.:thanx:
 

GStough

Staff member
Super Moderator
Re: How do you handle missing information? People seem to "forget" to enter informati

Hello all,
I take it back just like everyone else does, and let them know that if its not filled out each time that I stop bringing it back but let them come to me and fill it out and ask why its so hard for certain aspects to be filled out and change it if it needs changing. My question is it ok to let someone initial and date the top box then line down to the last box. Will an auditor find this ok or unexceptable? I get differ answers from people.:thanx:

What do your procedures tell you to do? In our procedures for quality records and recordkeeping practices, we state that "ditto marks", or "line down" as you describe, are unacceptable. For our products and processes, this works best for us. It represents a more "complete" record, filled with data (even if some may be identical), as opposed to a form with someone's initials at the top of the page (as in your example) and the first line of data filled, followed by lines drawn down the page with no other information filled in.

Hope this helps...:bigwave:
 

Stijloor

Staff member
Super Moderator
Re: How do you handle missing information? People seem to "forget" to enter informati

Hello all,
I take it back just like everyone else does, and let them know that if its not filled out each time that I stop bringing it back but let them come to me and fill it out and ask why its so hard for certain aspects to be filled out and change it if it needs changing. My question is it ok to let someone initial and date the top box then line down to the last box. Will an auditor find this ok or unexceptable? I get differ answers from people.:thanx:
Unacceptable! Each field, in which data has to be entered, is there for a reason. If not important, change the form. When I audit, I ask what that line represents....;) and its significance.

Stijloor.
 
K

KarenKH

Re: How do you handle missing information? People seem to "forget" to enter informati

There is nothing in our procedure at this time stating anything about lines or dashes. That I must change it seems. Some feel its a hassle to initial and date each line. Thats why I wanted to check, I dont want the auditor when they check to ask questions. :thanks: I may change the form were it has just a name at the top, ugh then if some one else takes over that could be another issue, unless i leave enough room so the person can state where they took over building the part.
 

GStough

Staff member
Super Moderator
Re: How do you handle missing information? People seem to "forget" to enter informati

There is nothing in our procedure at this time stating anything about lines or dashes. That I must change it seems. Some feel its a hassle to initial and date each line. Thats why I wanted to check, I dont want the auditor when they check to ask questions. :thanks: I may change the form were it has just a name at the top, ugh then if some one else takes over that could be another issue, unless i leave enough room so the person can state where they took over building the part.
Karen,

I understand your concerns, but once everyone has been trained and demonstrated competency, and the reason for completely filling out the record has been explained, hopefully the light bulb will come on for them and resistance will go away. And, once they get into the habit of doing it, they will teach newbies the correct way to complete the records. Or at least that's the idea. :tg:

Yes, it may be a bit of a hassle in the beginning, but eventually it will become part of their usual routine and will be second nature.

Good luck! :agree1:
 
K

KarenKH

Re: How do you handle missing information? People seem to "forget" to enter informati

Thank you all for the help. I am the only QC for now and all the help I can get is appriciated. :D I will be making changes to some of the documents and process so hopefully things run smoother. :magic:
 
J

JaneB

Re: How do you handle missing information? People seem to "forget" to enter informati

My question is it ok to let someone initial and date the top box then line down to the last box. Will an auditor find this ok or unexceptable?
Do remember you have a system for you and not for your auditor. So make your system work for you (not your auditor). The auditor's job is to review your system against the defined requirements - relevant Standard/s plus any you have stipulated.

I and other auditors don't have a problem with 'inclusion marks' or the like, provided that these do not introduce any ambiguity and it remains absolutely perfectly clear who authorised or did what. Those are the key points - and presumably the reason for the form in the first place, which is where the focus should stay.

Unacceptable! Each field, in which data has to be entered, is there for a reason. If not important, change the form.
I agree with some of this, but not that it's 'unacceptable' overall.

I usually agree with you Jan, but here not fully. Do agree to some extent with the advice to change the form - if that's relevant and wise. (There may be occasions in which sometimes a form is filled out by only one person and sometimes by different people and the 'one size fits all' won't work).

If so, I wouldn't force the one person to have to individually sign and date every single line in that case - with the stipulations above of course. That would feel to me like quality was just promoting 'busy work' of dubious value and refusing to ever be flexible, which I think it should.

So - I'd look at either altering your procedure/instructions (for example, add in rules about no ambiguity and things must be clear) and/or your form.
 
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