QMS for Life Sciences
Elsmar Cove Forum Sponsor

Redoing the QMS to be Simplified

N

Northwoods

#1
Most Important: The forum has helped me get through (9) months of resistance and challenges. It?s awesome to read, meet and see the best ?Quality? people in the world. Thank you. :thanks: and this is my 1st Post.

Quick background: 35 years in printing-advertising-production-project manager-buyer. Includes color checks on largest presses in the country for Fortune 500s & State Univ. In my teens/college years-operated small presses/shops in closets. Now-1 year behind me in ISO (2 Print shops-includes internal/surveillance audits). Quality matches me...

Enough fluff-Here?s the scoop: Almost finished with a sound electronic & hard copy quality control system for a commercial family owned print shop (45 employees-90% been here for 30yrs plus-very nice people) . I inherited a system set-up from an ISO kit- did not fit them. I suggested a redo when I started but resistance (owners-who hired me) & managers (3 Total). So I pulled it together with existing documentation & made extensive spreadsheets-etc. (working in Windows XP/2002 fun fun:mg:-yep resource issue). Mind you, I am not part of the process nor production and not been allowed to go on the floor/interview/ or observe for procedures. Lucky-I have worked or order jobs that have used almost every process in printing.

Almost done, now their saying it?s too complicated (really!!) :bonk:and it?s not working (they have not implemented-no meetings-etc.-wonder why) & now they dont want to be certified.:whip: (I will archive what I have - for they may change their mind later)

I?ve got past my bruised ego :lmao:and have a ?new? plan (simple/simple/simple). Make this a (3) layer system (My boss likes it-for now).

Wanted to post this plan below to see if I am on the right path before I start. Looking for your kind thoughts & suggestions: (remember all documentations, coding system, charts, training is set-up & done)

1) I am going to pick 3-4 main core processes from their existing Process Procedure (Quality) Manual (there is now 8)

2) 2nd layer will be for the production departments (about 4-5) & pick 1 major SOPs/ processes for each dept. (written & done-just need to reformat everything). Example would be: Best Practices in each department. It will cover Safety/Setups/quality & inspection pulls etc. The repeat stuff that applies to different equipment/procedures (Printing is all about quality & unique- no 2 widgets are the same here)

3) 3rd Layer - from those main SOPs there will be WIs (work instructions) & Checklists

Additional Challenges::2cents:

-They want to remove all of the objectives/responsibilities/supporting documentation from everything. I am fighting to keep the codes in the main SOPs or make (1) spreadsheet that tracks everything. All forms are set-up to the current codes now. (I can make them in 4pt font in the footers.)

-Also they want checklists that would be posted by each machinery (which is great-but I want codes for proper tracking of changes etc.) they dont. This really messes up the electronic/hard copy drafting/revision system already done.

Any input/suggestions/recommendations etc would be greatly appreciated so I dont run fast & far away before my next adventure... :thanx:
 

John Broomfield

Staff member
Super Moderator
#2
Northwoods,

The resistance to doc codes is interesting. Don't printers use similar codes on their print jobs? I can usually find them and they also usually record the size of the print run.

Perhaps this is their way of resisting your ideas until they feel they've been listened to.

Ask how would they would prefer to refer to their management system docs? The shop may not be big enough for fancy revision control.

You can probably let go of your idea of the multiple layers of doc types.

You could start with what the users want - checklists on each machine.

Park every other idea you have for them and run with their request and do it really well. Perhaps ask them if they'd like photos too.

Then they may trust you enough to adopt a few if your good ideas.

I'm sensing that a little humility will go a long way.

One benefit of the as-is rule is the procedure is already implemented ready for use and improvement. Better to do it this way instead of forcing change on them. Let them change it themselves when they see the need to improve.

Best if luck,

John
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hi there,

The most important thing to learn in quality is that without top management buy-in you are doomed.

IMO - cut your losses and get out of there. The writing is on the wall. These guys are FUBAR. I don't think they even know what they want.

Good lesson though.

Cheers,
Ronen.
 
N

Northwoods

#4
Hi John,

Thank you for your quick responce. The irony is it was their system I streamlined and cleaned up that they took from the ISO kit. As we moved along (in the 9 months) all was reviewed & approved.


In responce to Codes in printing. Codes would only be printed on jobs that customers supply on the art. A printer does not add anything a customer doesn't not have on supplied art. When you see codes that usually is tracking something such as: marketing movement, buying habits, inventory, promotional material etc.
 
N

Northwoods

#5
I wanted to add one more comment. From the beginning I made it clear, I would provide examples and samples and they could do anything they want and change it anytime how they feel it would work.

mmm...that bit me..I did not expect it 9 months later. So I will appease them until my next adventure
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Northwoods,

The resistance to doc codes is interesting. Don't printers use similar codes on their print jobs? I can usually find them and they also usually record the size of the print run.

Perhaps this is their way of resisting your ideas until they feel they've been listened to.

Ask how would they would prefer to refer to their management system docs? The shop may not be big enough for fancy revision control.

You can probably let go of your idea of the multiple layers of doc types.

You could start with what the users want - checklists on each machine.

Park every other idea you have for them and run with their request and do it really well. Perhaps ask them if they'd like photos too.

Then they may trust you enough to adopt a few if your good ideas.

I'm sensing that a little humility will go a long way.

One benefit of the as-is rule is the procedure is already implemented ready for use and improvement. Better to do it this way instead of forcing change on them. Let them change it themselves when they see the need to improve.

Best if luck,

John
Generally that would sound reasonable but

not been allowed to go on the floor/interview/ or observe for procedures.
If that's not an alarm bell then I don't know what is.

I would stay there only if desperate for work, and definitely that's not a good place to come to a job from. One aspect of humility is being able to say "this one is beyond my powers and I have to let it go".

Cheers,
Ronen.
 

John Broomfield

Staff member
Super Moderator
#7
I wanted to add one more comment. From the beginning I made it clear, I would provide examples and samples and they could do anything they want and change it anytime how they feel it would work.

mmm...that bit me..I did not expect it 9 months later. So I will appease them until my next adventure
Northwoods,

I'd also recommend that when you design your service spec that you define the responsibilities of both parties in developing the management system.

To help simplify a management system you must have access to the shop floor and to the workers.

John
 
N

Northwoods

#8
Ronen-Thank you for confirming what I already knew..just needed to hear it from other professionals in the career. . I am stuck until I find something else-which has been really challenging. ........so many red flags...
 

hogheavenfarm

Quite Involved in Discussions
#9
Hello Northwoods,
I am in the same position, so you have plenty of company I am sure.
Here is what I did learn.
The ISO-Kit we had when I started had 'distance' between management and 'ISO', it was seen as an add-on, just a separate piece of bureaucracy.
After years of streamlining the system, it is now much more 'attached' to management, this appears to make them uncomfortable, since it reflects what they say they are supposed to be doing, rather than saying some abstract ISO-manual doesn't relate to them. Making it hit closer to home is not making them feel warm and fuzzy.
It seems much harder to see the system as an add-on now, as a result, you get push back on it. That's okay, just means you are doing it right, consider it practice for someone down the line that will really appreciate it.
 
N

Northwoods

#10
Thank you hogheavenfarm (LOL on your handle). You are absolutely correct. Nine months of me saying anything you want, now almost done-so I can leave this corner of writing all day & do over.

I am looking at it now, I have (3) systems built for my portfolio... hoping to get all done in 2 weeks- but know it won't be what they want again. Your comment on the push back-really hits home.

Thanks again
 
Top Bottom