Labeling Control and trouble with labelers not following procedure

T

Tara Burrell

#1
Please, some help!
I have a 2 person team of labelers... needless to say, they have a serious personal vendeta against me... honestly. The management is absent (too busy to monitor) and I am the ONLY person in quality/regulatory. I have created a procedure for me to review the labels before they are applied to our medical products. The labelers DO NOT FOLLOW. Could anyone suggest how I can have more of a check and balance? I am creating a labeling systems to eliminate errors (linked fields). I would like to print one of each product label and save a copy for the records so that we know what is sent (to refer BACK to).
Please, how do other companies control the labeling?
Tara
 
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Stijloor

Staff member
Super Moderator
#2
Re: Labeling Trouble

Get these folks to help you develop a method that works.
Involvement may lead to commitment.

Stijloor.
 
M

MIREGMGR

#3
Labeling of course is just one of the things that a medical manufacturer has to do every day under control. What is your day-to-day senior management's attitude toward conformance?

It's not their job to "monitor". That's the job of whoever the individuals in question directly report to. In the company for which I work, that's the Manufacturing Manager; perhaps it's different for you.

It is their job to set the company's attitude, though. Attitude must start at the top. If the day-to-day senior manager makes it clear by his or her own attitude that of course the company will operate in compliance, that conceptually there's not even consideration given to any other approach, then the job you're doing becomes that of a facilitator, trainer and subject matter expert.

If Production's reason for objecting to the procedure is that it's too slow...can't ways be found to speed it up? Follow Stijloor's approach. Have someone else do the checking that's always available. Have them check against each other, with clear buy-in by their direct supervisor that the check process is critical. Find a way to address their specific objection.
 
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Randy

Super Moderator
#4
Easy...everytime they don't do what they're paid to do don't pay them...

Of course some of these folks will object to that, but just think of Pavlov and his dogs.
 
T

Tara Burrell

#5
Thank you all for your responses. Our company is small, and Executive Management is also HR, payroll, some sales, Engineering... We all have so many tasks to master because we have only 6 employees.

I have set the systems up so that I (QA/RA) verify the labels before they are applied. They go behind my back and choose not to follow the instructions and there are never any consiquences.

How do other companies label? What are the checks and balances? What do other S.O.P's say? Labeling is SO important to a medical device and I am having trouble relaying that to others.

Does anyone have an article about the NEGATIVE effects of incorrectly labeling? I think that I will be able to better relate to these people with an analogy or something?!!!!

Thank you again,
Tara:eek::thanx:
 
P

Phil Fields

#7
Please, some help!
I have a 2 person team of labelers... needless to say, they have a serious personal vendeta against me... honestly. The management is absent (too busy to monitor) and I am the ONLY person in quality/regulatory. I have created a procedure for me to review the labels before they are applied to our medical products. The labelers DO NOT FOLLOW. Could anyone suggest how I can have more of a check and balance? I am creating a labeling systems to eliminate errors (linked fields). I would like to print one of each product label and save a copy for the records so that we know what is sent (to refer BACK to).
Please, how do other companies control the labeling?
Tara
Tara,
It sounds like you have quite a mess to control.
Per 21 CFR Part 820:
• Personal 820.25(b)(1): As part of their training, personal shall be made aware of device defects which may occur from improper performance of their specific jobs.
• Device Labeling 820.120 (d): Labeling operations: Each manufacture shall control labeling and packaging operations to prevent labeling mixups. The label and labeling used for each production unit, lot, or batch shall be document in the DHR.

The regulations define what needs to be controlled. Use the regulations with both management and the workers to implement corrective action.

In the event that your company needs to recall product, or a field notification, can you positively recall product in the manner that it is currently being labeled and identified on the DHR?

Phil
 
M

MIREGMGR

#8
You have a total of six employees, including yourself, and two of them refuse to follow procedure for a regulated process?

With all due respect, whoever owns your company has a problem.

Additionally, it sounds as if there is a big disconnect between your vision of your job, and your boss's.

Who approves the procedures? Was the labeling procedure approved? Was training conducted? Were objections raised during those processes?

You don't need "an article" about labeling. You only need the first sentence of 21CFR 820.120 "Device Labeling"...compliance with which is legally mandatory for medical device manufacturers in the US.
 
T

Tara Burrell

#9
No offense taken..
I wrote the procedures after interviewing and auditing the appropriate departments.
Management approved them.
As far as training goes.... we are lacking in that area. I have gone over with them in a structured meeting what the NEW process is, but there was never any signing off in it that they accepted the training.
I guess that is where I need to start. I am new to this field with only one year of experience here and NO previous experience. I have come to love the QA/RA field, but am sick of working with people that don't have a quality mantality.
Thank you for reffering to the CFR... I will start there in implementing this procedure.
P.S... only sell overseas, but our QMS is written to conform to MDD, ISO 13485 and CFR 820....
Thanks again
Tara
 
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