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Informational Please help this newbie understand ISO 9001 Work Instructions

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Shannon S

#1
I work for a small label printing company (approx. 25 employees). I have been here for 3 years, and I have just taken over our quality control. Let me start by saying that I have no quality experience at all, so this is all new to me. We are seeking ISO certification. My understanding is we were certified to the '94 standard, but to be honest, they were simply seeking the certification and did not really implement anything. We do need the certification for some of our customers, however, we do have some issues and I am a firm believer we can fix most of them if we can implement some changes and standardize our processes. I am pushing for us to actually do this right this time!

We have contacted a registrar and had a pre-assessment done. I have also attended all of the training classes and the lead auditor course offered through our registrar. I stumbled upon this website, and I've been lurking around reading everything I can on here. You are a very knowledgeable and helpful group of people, and the information I've gained already has been so appreciated! :thanks:

Thus far, I've written our manual, written the 6 mandatory documented procedures (there will be more), and now I am trying to tackle work instructions. Here, I am at a stand still! I just can't seem to figure out how or what to do with this! The owner of the company seems to believe that I don't need to write any work instructions. My registrar says, "I would not audit you're WI but would need to understand how you could control production without WI".

I'm sure there are threads that already discuss the answer I'm looking for. Before you beat me up too bad, :whip:I swear I've read all over this forum for 2 weeks about every topic that has come up for me as I'm going through this process. So, if any of you have a minute to offer your wisdom or point me in the right direction...I'd be so grateful! Oh, and I need layman's terms....please!
 
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tori2432

#2
Re: Can you help a newbie?

Think of a work instruction like an owners manual for a car.

Title: How to start your car

Purpose: this instruction details how to start your car

Reference: car, keys

Instructions
1. Get in car and shut door
2. Put key in ignition
3. Turn key clockwise until car starts


If a new person came into the company, how would they know what to do at each station? You would make a work instruction.
I would suggest looking at some train the trainer material so you can have a good understanding of how people learn.

At a different job, we used a lot of pictures of the machines and made them simple so anyone off the street would be able to just walk in and work a machine.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#3
Re: Can you help a newbie?

The owner of the company seems to believe that I don't need to write any work instructions.
Welcome to the Cove! Thanks for lurking:D

The quote above from your post seems to be a pretty good place to start.

Through your lurking around and reading the threads here, you've probably come across the concept a few times that

{If top management doesn't drive it, it will go off the rails}

Start with understanding what the boss wants. If he or she is not your ally in this, you've got a really tough road ahead.

The one who pays you to fix things has to be behind the changes or else they will feel like they are wasting the money on you regardless of what improvements happen.
You can't fight City Hall.

I'll bet you've got a lot of great advice coming...but remember that without the boss behind you, your task will be much harder if not impossible.

So what can you do to get on the same page with the boss...or to have the boss change what page he/she is on.

From one of my long-ago posts...Knowing what owner's want from you is always easy: Owners like MONEY. Put it in dollars and cents. How will implementing a functioning quality system increase Net Profit After Taxes?
 
B

Bjourne

#4
Re: Pls help this newbie understanding ISO 9001 work instructions

I'll send you one ref doc soon. I just need to edit some stuff out of it. I'll get back here when it's done. It's an old document but it's detailed. The new documents has attached images per workstation instruction and is quite large. But if you can wait I bet you can take a hint on what I am saying. Be back soon for my help. :)
 
P

PaulJSmith

#5
Re: Can you help a newbie?

Welcome, Shannon!

Good advice so far, as you have come to expect.

I'll try to add to that by suggesting you keep it simple. Only write in as much detail as necessary to do the job. The more involved in details that you get, the more daunting the task. You can always edit for more detail later, if necessary.

Another suggestion is to let the people doing those jobs or the process owners write the Work Instructions, or at very least let them tell you what they do so you can write them in a more informed manner. This will both give the correct methods used, and get everyone involved in the project. You'll get much better buy-in that way, as opposed to you telling them what to do.

Good luck.
 
T

Tara Monson

#6
Re: Can you help a newbie?

I agree - you must have top management on board with this or it will ultimately fail.

Buuut, to get started I like to do a process map. Take a final product and walk through the steps, creating a flow-chart. Use this flow chart do determine what WI need to be written.

Keep them as simple as possible...because as your auditor stated...it's not required that you have WI...but if you do have them, they must be followed.

Good luck!
 

Ninja

Looking for Reality
Staff member
Super Moderator
#7
Re: Can you help a newbie?

Another suggestion is to let the people doing those jobs or the process owners write the Work Instructions, ....
Paul is spot on (as usual), but forgive me if I amend based on a hard lesson learned...

Let the people doing those jobs write the {First Draft} of the Work Instructions.

I've found that process owners tend to paint themselves into corners as a rule. Get the first draft from them, then work with them to determine how much freedom they took away from themselves and give it back to them.

Fenced path: Define the path, but put the fences a bit wider than the path so you don't keep hitting them (assuming of course that that freedom does not detract from the product.)

I still have a work instruction floating around here somewhere requiring that records be written in blue Uniball micro pen...even got a finding on it (laughingly) by an internal audit since that pen was discontinued years ago and we don't have any.
 
#8
Re: Can you help a newbie?

Think of a work instruction like an owners manual for a car.

Title: How to start your car

Purpose: this instruction details how to start your car

Reference: car, keys

Instructions
1. Get in car and shut door
2. Put key in ignition
3. Turn key clockwise until car starts


If a new person came into the company, how would they know what to do at each station? You would make a work instruction.
I would suggest looking at some train the trainer material so you can have a good understanding of how people learn.

At a different job, we used a lot of pictures of the machines and made them simple so anyone off the street would be able to just walk in and work a machine.
But the manual is written this way because the car makers have no control over the competency of the driver! Frankly, if I were given a work instruction written like this, I'd throw it back at the supervisor! What about the people who all ready know how to drive? Don't organizations employ people who have "been there, done that"? I think this proposal is exactly what ISO 9001 ISN'T about. Some people don't need a work instruction at all - skills, experience and knowledge replace the need. Even if you do write it down, that's NOT how people get trained. Believe me, it isn't effective to teach people how to use a car from reading the manual!
 

normzone

Trusted Information Resource
#9
Re: Can you help a newbie?

All of what they said - and having recently been set free from my previous team and now playing for a competitor half the size, I advise you to revel in the simplicity available to you. More is not better.

You can always add more later if there's evident value to doing so, but begin by trying to keep it as bone simple as you can. Don't worry, there will be plenty of opportunities to add to it as it ages.
 
N

Northwoods

#10
Re: Pls help this newbie understanding ISO 9001 work instructions

Hi Shannon,

I started a new job a year ago and the 1st day they said ?Here, you have a surveillance audit in 6 weeks? Had No clue what I was getting into but then realized quality has been my job in printing for over (30) years but did not know there was an actual job title for it. To bad for me.

I have been on this forum for about 9 months now and have learned tons and its a great resource. Thanks everyone. This is my first time posting since I feel I can help

You will read everywhere on this forum, however you set-up your system is up to you and management but make sure it works for your plant and it is consistent. If you are just pleasing the CB auditors you will not get anyone's attention or care in your plant.

Ok the nuts & bolts- Since I have conducted internal audits and surveillance make sure your auditor will know printing. Otherwise it will be a big challenge.

A good way to start is to take all the depts above place them on a piece of paper or a flow chart. From there draw lines for the major steps. We in printing know each and every job is unique but there are common processes of getting the job in the plant and out the door on time to the customer

Think about your major departments (processes) on how the job comes in and how it goes out. Example: Sales (receives order from customer & gives to CSR), Customer Service (processes order and writes up Job ticket & gives to Prepress), Prepress (Receives Job Ticket from CSR, art files uploaded to preflight, proof or plates are generated from art), Press Room (Prepress sends plates to Press, Press prints job) Finishing, (Press gives printed job to Finishing - each process in Finishing can be a WI (Cutting/Saddle-Stitch/Collating etc) then Shipping & Receiving (Finishing gives to shipping either packed or ready to send out to the customer

Once you get your basic processes go from there. Make the next layer of details. You will start to see the circle forming when you know you have most of your basic steps done. Also watch your processes (if they let you) and if there is step that is not done often and people have to ask-write procedure or checklist

We actually call out our (WI-Work Instructions) SOPs (Standard Operating Procedures). Our (WIs) are the details/checklists. I have set-up a coding system that starts with the letters of the department then placed a numeric next to them. Such as PP-01 (Prepress 1st procedure)

Just one more bit of advice the printing world has tons of forms. Start collecting all of them and get codes on them. The coding system on our forms match the same codes that the forms of the department they pertain to.

I hope that helps.:magic:
 
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