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How to determine which is the 'master' "controlled" version of document

J

JoHannah

#1
Hi, Cove people.
I have been searching the “Documentation Systems, Forms, and Templates” thread as time permits. Thank you all for what you do. I’ve learned a lot. Sorry for this long post:

I need help. The government test lab where I work is seeking ISO 17025 accreditation. Some of our customers provide us with e-mail messages and attachments that contain time-sensitive information about their specifications: test methods, procedures, and related instructions and forms. Three or four people in the lab will receive the same e-mail and attachments, then I get a copy of the e-mail from one of them. Most, but not all of the documents have effective dates or revision levels on them. Effective date is always in the body of the e-mail. Most of the documents we get via e-mail from these customers are posted on their Internet Web sites, usually within a day or two of when we get the e-mail. Not that big of a deal, if nothing goes wrong. But there's a lot of room for error and what looks to me like a nightmare of copies of records to properly dispose.

When I get the e-mail, I ask my boss who should get hard copies. I print the relevant messages and attachments, stamp them controlled, and distribute the copies. I log the distribution information on that customer's master list. The customers usually provide doc numbers; when they don't, I give them a "CustomerProject-001." If there's no revision number or effective date on it, I just log the effective date they give in the e-mail. I keep each project in a ring binder: all project procedures and work instructions. Other correspondence related to the project is kept in a separate file.

Does this meet section 4.3 of ISO 17025 (which is just one of the standards related to documentation and record keeping that we have to meet)? Is there a better way to identify, on a master list or distribution lists, the current revision status and distribution of test methods, procedures, and forms that are printable from the World Wide Web? Paper copies, stamped "Controlled," of all the instructions are distributed to workers in the affected area and replaced as necessary, but the e-mails and attachments go who knows where; the Internet version is available to everyone at all times. There's nothing to prevent outdated versions of e-mail attachments or Web content from floating around the lab as hard copy or Adobe pdf. So that means for Customer-SOP-123 we have (for example):
-2 paper copies in identifiable physical locations
-3 or more identical electronic copies that came as e-mail attachments that are (maybe) stored in identifiable locations
-1 Adobe pdf on the Web at an identifiable URL to which all lab staff have access
-An unknown number of paper and electronic copies of the e-mail attachments
-An unknown number of paper and electronic copies that have been downloaded from the Web site.

How do you provide accurate distribution information for these things on the master list? What are the fields? How could you make a distribution list that shows this information? I guess we could just have a policy that says, “all paper copies are uncontrolled,” but that to me wouldn’t meet the spirit of the standard since it is often the paper copy -- not the electronic version on the other side of the room -- that actually guides the data-producing activity. If someone in the lab runs samples using a copy of a method that was printed from the Internet two days ago, and the copy is now obsolete, the data will not meet customer requirements. Not only that but…. And if someone has a printed version of an Internet download or e-mail attachment that IS the current version, don’t we still have to account for that instance of distribution, even if it is only for two days or whatever? How else could we know that the guy who ran the test had a copy of the correct version of the method at the time the samples were run?

I’m relatively new at this place (newer by years than the lab’s 17025 aspirations) and have recently become responsible for our “document control system,” which consists of a written procedure that addresses only internally-generated paper documents. I don't have any authority; my only power is the power of suggestion. There are less than 100 people in the lab. We use documents in paper, electronic, or both formats. People need and tend to want hard copies of methods and other instructions, but also refer to editable electronic versions that have been copied to myriad locations all over the share directory. :frust: This is what I inherited. Hostility to all things ISO and resistance to change are deep. We have made some progress by starting a master list of internal documents and master lists of documents we get from customers. We have also begun distributing internal documents electronically as locked PDF files (not editable Word files). To get even this far has been like pulling teeth. Are we pulling the right teeth? :tg: I would welcome any advice from Cove contributors. Thanks for all you have already done.
 
#2
Split thread

I split this thread off to avoid the "clutter" in its original thread.

Essentially, JoHannah asks "How do we establish the ONE master copy which we will control as a customer-supplied document and from which all subsequent copies should be made?"

I'd like to read a few suggestions from Covers and then we'll try to help our fellow Cover formulate a workable policy which will serve the requirements of customers and JoHannah's organization with the least amount of grief or disruption of the operations. Remember, the system must be able to pass a third party audit.
 

CarolX

Super Moderator
Super Moderator
#3
Why do you need a "Master List" of customer documents?


How about treating these documents as a job shop would control customer furnished drawings? As an order is received, issue the document and reference their order number on it, with a disclaimer that the document is to be used for that order only.

Just one idea.
 
J

JoHannah

#4
Hi Carol.
Thanks for the suggestion.

Why do we need a master list of customer documents? We don’t per se. We just need, according to ISO 17025, a master list or equivalent procedure for identifying the current revision status and distribution of all documents in the quality system. Active customer-supplied procedures, I think, are quality system documents. Putting all the ones that define a particular program (in which we are participating according to the terms of a customer contract) just seems convenient. All the procedures we get from that customer for that program in effect make up one chunk of the larger master list.

We are, in a way, a job shop, so I will keep your analogy in mind as I try to think of a better way to do this. An “order” for one of the programs would consist of a sample delivery group. All the samples would be logged in on Cust-Form-01, a subset of those samples would be analyzed according to Cust-Meth-01 Rev 0, another subset would be analyzed by Cust-Meth-02 Rev 1, and so on. All the data would be reported by Cust-Proc-01 using Cust-Form-02. That’s roughly how it works. Samples and data are meant to be processed according to the 75 or so customer-provided procedures and forms throughout the life of the project, during which the lab may receive a hundred or so sample delivery groups for that project.
 

CarolX

Super Moderator
Super Moderator
#5
Do you have some sort of "contract review" process?

When we receive a new order from a customer, we enter the part number and rev level. If the rev level doesn't match, the part is put on "hold" until a detail review is done.

Could you adopt a similar process for identifying current revision status?
 
#6
It seems to me even job shops establish who the contact people for themselves and for the customer will be and funnel communications and correspondence to those contact people either directly or by copying.

In practical terms, that means a technician or machine operator at a job shop would ask the sales department (contact person) to put him in touch with an engineer or quality person at the customer to clarify a point about the product being manufactured. The contact persons at both job shop and customer would be aware the conversations took place and might get memos of the gist or substance of the conversation, but they might not necessarily be in a conference call.

The task is to help customers understand they will get best service if they reduce the number of opportunities for error by only transmitting written documents and data to the contact person who can maintain configuration management of the most recent approved version. The contact person at the supplier ensures ONLY the most recent approved version is available for supplier staff to work with, collecting and removing obsolete copies from the production area and either destroying them or maintaining them in a segregated "history" file.

Staff who receive documents direct from customer give them to the contact person for management and control.

Terms to google while you wait for more responses - use quotes (") around entire phrase:

  • Configuration Management
  • Document Control
  • Document Management
  • Associated Documents
  • Electronic Document Management
 
J

JoHannah

#7
Thanks, Carol and Wes.
These are good ideas that seem reasonable to me. :yes:
Our “contract review process” is rather informal; that’s part of the problem. I need to explain that the organization I work for is not currently registered or accredited to ANY quality standard, so we have a bit of catching up to do. I will pass these ideas on to the powers that be. It is kind of sad. The time available for “working on ISO” is eaten up by the need to “put out fires” that started because there is no quality system… :(
 

Caster

An Early Cover
Trusted
#8
You have your hammer!

JoHannah said:
The time available for “working on ISO” is eaten up by the need to “put out fires” that started because there is no quality system… :(
Ahhhh....you have the ultimate tool to drive improvement.

May I suggest that each time you put out a fire, you take 10 more minutes, identify the ISO clause that "MAY HAVE" prevented the problem had you followed a system. Try to attach a dollar value to the problem. Failing that, just track hours spent fire fighting.

This is a mini cost of poor quality study and should easily show a dramatic payback!

It's the same amount of work, just done at a different time (up front instead of after the fact). It's a lot nicer to spend your day preventing than reacting (unless your job is actually firefighter)

Good luck!
 
#9
It's the same amount of work, just done at a different time (up front instead of after the fact). It's a lot nicer to spend your day preventing than reacting (unless your job is actually firefighter)

Good luck!

I learned a lot from the fire marshall who conducted our semi-annual survey. - Sometimes, even the firemen would rather PREVENT fires than put them out!

My favorite was when he took us out to the parking lot and threw a lit cigarette into a pail of gasoline and we all watched the cigarette just fizzle as if it were a pail of water. Then he put about a tablespoon of the same gasoline into an empty pop can, laid it on its side and slid a lit cigarette to the open end of the can with a long stick. Spectacular!
 
J

JoHannah

#10
I see many nails

Thanks, guys!
:lol:
Actually, I am trained in firefighting. Before this job, I worked production in chemical plants. The first chemical plant I worked in had "just become ISO" when I was hired back in the early 1990s. The second chemical plant I worked in adhered to no standard that I was ever aware of.

The first place was a union shop and rotated shifts. The second place was non-union but straight days. At the first place, hands-on fire training was mandatory every other year; on-going, related computer-based training was also mandatory. At the second place, I discovered that the training records of my co-workers had been falsified. :mg: They hadn't been trained to handle chemicals, run equipment, monitor reactions, inert a reactor, ground a drum, label scrap, nothing. Firefighting, forget it. Written instructions? Not there. Equipment specs? Somewhere, but not accessible. So now I'm in an open shop, fighting fires from my cubicle.

Caster, I take your advice to heart. Actually, I've done these things. Tomorrow, I'll have to do them again. :tg:
 
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