I need some opinions,ideas, or suggestions. My company is subject to Management of Change regulations by the US EPA and the US OSHA. We currently manage the process on paper but have an opportunity to tighten up our system by using, among other tools, ISO related software (we're ISO 9000 registered and are considering ISO 14000 compliance and possibly registration). I'd like to create a Management of Change procedure and work instruction bit I'm struggling with the "tightness" of our system. We currently can have only one current document, for as example, a unit operation, say Reactor 345 Operations. We can do a change request and either specify a date or allow it to become the current document upon completion. The problem is that it may not be possible to specify a date when the change can be made nor is it likely that we can implement the change (and retrain on the change) exactly on the date that it gets to the approved and completed phase. We don't really want to create a situation whereby we plan to not conform to our own procedures!
One option is to create another procedure that could exist co-currently, in other words, either or could be used.

I need some opinions,ideas, or suggestions. My company is subject to Management of Change regulations by the US EPA and the US OSHA. We currently manage the process on paper but have an opportunity to tighten up our system by using, among other tools, ISO related software (we're ISO 9000 registered and are considering ISO 14000 compliance and possibly registration). I'd like to create a Management of Change procedure and work instruction bit I'm struggling with the "tightness" of our system. We currently can have only one current document, for as example, a unit operation, say Reactor 345 Operations. We can do a change request and either specify a date or allow it to become the current document upon completion. The problem is that it may not be possible to specify a date when the change can be made nor is it likely that we can implement the change (and retrain on the change) exactly on the date that it gets to the approved and completed phase. We don't really want to create a situation whereby we plan to not conform to our own procedures!
One option is to create another procedure that could exist co-currently, in other words, either or could be used.
Just so we are on the same page, are we talking about Management of Change (MOC) as summarized in this paragraph?
http://www.osha.gov/doc/outreachtraining/htmlfiles/psm.html (http://www.osha.gov/doc/outreachtraining/htmlfiles/psm.html)
MANAGEMENT OF CHANGE

OSHA believes that contemplated changes to a process must be thoroughly evaluated to fully assess their impact on employee safety and health and to determine needed changes to operating procedures. To this end, the standard contains a section on procedures for managing changes to processes. Written procedures to manage changes (except for "replacements in kind") to process chemicals, technology, equipment, and procedures, and change to facilities that affect a covered process, must be established and implemented. These written procedures must ensure that the following considerations are addressed prior to any change:

The technical basis for the proposed change,
Impact of the change on employee safety and health,
Modifications to operating procedures,
Necessary time period for the change, and
Authorization requirements for the proposed change. Employees who operate a process, and maintenance and contract employees whose job tasks will be affected by a change in the process must be informed of, and trained in, the change prior to startup of the process or startup of the affected part of the process. If a change covered by these procedures results in a change in the required process safety information, such information also must be updated accordingly. If a change covered by these procedures changes the required operating procedures or practices, they also must be updated.

If so, it seems to me one of the crucial factors in the MOC is Necessary time period for the change.
In my mind, that means estimating the time to get the "assets" to implement the change. Assets include: raw materials, capital equipment, installation, regulatory approvals, trained staff to operate the change (including the time and resources necessary to train existing employees or hire employees with the requisite training.)

This is no different in the basic elements than any manufacturing organization which has a pending Engineering Change Order. The concept of Configuration Management also comes into play here because the "change" cannot be fully realized until all pertinent parties have notice and the assets are in place to implement the change. Often, the Configuration Management and Engineering Change Order include the plan for the disposition of the soon-to-be obsolete products, raw materials, work in process, capital equipment, products already in the field, etc. etc.

What am I missing that makes "Management of Change" seem to you like something different and unique from any routine (or extraordinary) change in a manufacturing environment?

Maybe you could specify a NLT (No Later Than) date and a provision for review if it is determined the date would not be achieved?

Keep it as simple as possible to avoid misunderstanding and confusion (keep the engineers away from it):lol:

Wes,
Thank you for your thoughful insight. It may be that I am (we are) over complicating the matter. I think you've hit the nail on the head with the emphasis on the "neccesary time period for the change". It occurs to me that we must understand and develop ALL the criteria surrounding the change (including the time period), document it, and communicate it effectively. Paper may be easier.

Wes,
Thank you for your thoughful insight. It may be that I am (we are) over complicating the matter. I think you've hit the nail on the head with the emphasis on the "neccesary time period for the change". It occurs to me that we must understand and develop ALL the criteria surrounding the change (including the time period), document it, and communicate it effectively. Paper may be easier.
There ARE software solutions which can obviate the need for shuffling paper. I have written about "Electronic Document Management" on a number of occasions. Take a look at this post which I recently posted in the ASQ Forums. It summarizes material from several Cove posts.Here is a copy of a post I wrote several years ago - most of it is pertinent today.

here's a copy of something I wrote on the ASQ Forum on 9-3-2004:
Quote:
I know lots about "electronic document management" (EDM) software.

I need a lot more information about the scope of your operation to make a meaningful suggestion.

Make sure you know and understand the difference between "document sharing" and "document management."

Here's a brief summary to start you off:

Document Management Software

Background:
An organization wants to improve efficiency of document management by “grafting” a program over current legacy files and all newly-created files which will provide the following minimum benefits:

a) Ease of Search & Retrieval (on different fields/characteristics)

b) Ensure only the most recent revision is available on standard Search menu

c) Automate the procedure of notifying pertinent parties a document is ready for redlining

d) Maintain an audit trail for the status of documents (released or waiting for checking/approval [and by whom])

e) Allow “full preview” of documents without opening native programs – i.e. AutoCAD documents can be viewed without latest revision of AutoCAD being resident on user’s computer.

f) Permit “group printing” of documents, regardless of native file format.

g) Maintain up to 30 security levels on any document, determining whether user has authority to create, modify, redline, view, print, copy, etc.

How do they work?
The primary feature of Document Control Software is a relational database which manipulates very small files called “metatags”, which relate to certain attributes of documents. Basic attributes are file name, revision level, author, topic, key words, type of file format, etc. which are used for field headings in the database.

By querying the database, a user retrieves a “menu” of documents which meet the search criteria. Self-contained viewing software permits a user to view and print documents, regardless of the native file format. The views can be scrolled, zoomed, and cropped (i.e. user can print an enlarged detail of a document.)

Users who have redline authority can markup documents without invoking the native file program (the redlines are saved as “overlays” in separate files without changing the original document.)

Users who have checking/approval/redline authority can be automatically notified via email when a document is ready for their review. The program will track when and whether the review is completed and maintain an audit trail for “real time” status reports on any or all documents in the review process.

By keying on the attribute “Revision level”, the program can ensure only the most recent, authorized revision is available to most users, reserving authority to view “superseded” documents to special categories of users.

An important consideration in grafting legacy documents into the new system is choosing fields pertinent to the organization. Many documents, like autocad and word documents have features which provide automatic tags (create date, author, department, etc.) [click on "properties" under File in a Word document to get an idea of already available fields.]

The problem is most users write documents which still show "valued customer" as the author because they have never explored the Properties feature.

An expense to consider is going back into each legacy document and adding the meta tags which allow for sorting and retrieval.

I hope this helps - there are many consultants like me who would come in and give your organization background on choosing the best brand for your organization. Caution is "Are they truly independent or do they have bias toward one brand?"-Wes Bucey, Quality Manager

I didn't add in that post that most software programs have web versions, too. In point of fact, the documents "could" be located either on one server or scattered among hundreds or even thousands of hard drives or servers as long as they were connected or accessible via password over a network, a virtual private network, or the internet.

Somewhere else, I wrote
Quote:
Why not take the entire QMS system paperless? Is your company a public company? Will you ultimately want to include Sarbannes in your thinking?

It appears the toughest part is that you want to go back and include all your legacy data (FAI) as well.

Google "electronic document management" to see some other thoughts on this topic. I hesitate to recommend ANY product by brand name, because the competitive nature of the business is that one company can be hopelessly obsolete in a month or two and another can have a great breakthrough in the same period. Regulatory laws change quickly - a user's current and projected situation in that regard are important factors. Current quantity of documents and projected number of authors and changes are a major factor. Collaboration with suppliers and customers is another big factor.

-Wes Bucey, Quality Manager