Session 21E

Document Control for ISO 9001.2008 Beyond Efficiency

Barbara Butrym
barbb@qpsinc.com 508-450-4241

Barbara Butrym: Consultant and trainer for QPS Institute with over 25 years as a quality professional in Aerospace, Telecommunications, Automotive and Medical Device industries. Barbara is RAB certified auditor and principal of BQA Quality Services. Contact Info: barbb@qpsinc.com 508-450-4241

Document Control is a necessary evil

Since we gotta do it, how can we get value out of it?

Once we get it running efficiently, what next? What are some measurable goals?

What is ISO 9001:2008?

ISO

= International Organization for Standardization ISO has representation from 157 countries and has issued many standards ISO 9001:2008 is a model for a quality management system.

What is a Quality Management System?

A Quality Management System is a web of interconnected processes that are used to manage a business.

Why do we do this?
Standardization
Customer

Requirements Regulatory Requirements Good Business Practices

What does ISO Registration Require?

Say

what we do Do what we say Prove it Continually improve

Document Control 101 Copyright 2002 Craig Cochran Originally published in the June 2002 issue of Quality Digest

Document control is possibly the single most critical quality assurance discipline. Information in the form of documents drives nearly every action in the organization, The ability to control this information can make or break the organizations success. Successful if it is simple, intuitive, and user-friendly. The first step is to decide exactly what documents need to be controlled.

REQUIREMENTS

ISO 9001:2000 Document Control (4.2.3) 1. Approve documents for adequacy prior to issue.
2. Review, update as necessary, and re-approve them. 3. Identify changes and current revision status. 4. Ensure documents are available at points of use. 5. Identify and control documents of external origin. 6. Ensure documents are legible and identifiable. 7. Prevent unintended use of obsolete documents. 8. Identify obsolete documents if they are retained.

Who Does this Affect?

Everyone in the company

Many of you will have some input into the creation of documents that affect your jobs. All of you will be responsible for knowing how to access procedures you need to know to do your job. All of you will be held accountable for following procedures that affect your job. All of you will be expected to participate in continuous improvement.

What can you expect?

Training! A lot more training than you ever had in the past. New systems for:

Document control Configuration Control Records Control

You may be asked to participate in writing procedures for your job. Feel free to volunteer!

What does a documented procedure look like?

Anyway you want it to Wordy formal printed documents, several pages long Visuals, photos, Digital images Multilingual Flow charts of any style Any combination None of the above

My Personal Favorites

Color Coded Flow Charts Swim Lane Flow charts Process Flow Charts
OH NO..so whats the difference?

4.2.3a Approval of documents All controlled documents are to be written and maintained the process owner of the document or the Quality Manager. Controlled documents written by process owners should be approved by a senior member of staff who has relevant experience in the operation of the process or the Quality Manager. Controlled documents written by the Quality Manager should be approved by the process owner or a senior member of staff who has relevant experience in the operation of the process. 4.2.3b Review and re-approval of documents Documents will be reviewed when any amendment(s) to their content are required. Amendments may be deemed necessary due to changes in either internal or external business environment. Re-approval will transpire using the same approach as described in 4.2.3a. Where possible the member of staff who approved the original document should re-approve any subsequent versions. 4.2.3c Identification of changes and revision status of documents An amendment control record will be maintained by the Quality Manager to record the details of any amendments made to controlled documents. 4.2.3d Availability of applicable documents Policies and procedures will be stored in read-only electronic format on the XXXX Intranet, which is accessible by all members of staff. Members of staff that are not based at the main office/warehouse site can access the Intranet using a VPN (Virtual Private Network) connection from their company provided computers. The content of the Intranet will be backed-up on to removable media on a daily basis and stored offsite.

Mark up the procedure in the control book with the correction in red

the authorized user or company president

Initial and date the entry

Notifications needed?

Yes

Notify or train affected parties

No Log the change onto the Change control log in the control book

Are there more than 5 changes since the last update of the procedure?

No

is this a major process change?

No

Are there any other controlled copies?

No

Return the control book to the control area

Yes Yes Make same change to All Control copies Yes

Initiate QF305-1

Doc control will make the changes to the procedure and update the control book and any copies

Change to a procedure or form D305-001 revision issue

Document Control
What does control mean? What do we have to control? How are we going to do this? Who is going to do this? Where can you find documents you need? What about paper copies?

guide the production of products ? guide the verification, inspection, or testing? define customer and/or product requirements? used for controlling processes? used for decision making? used for collecting data that could be used later for decision making within the scope of the management system (i.e., a form)? information on the document so critical that failure to keep it updated would pose a risk address or relate to a requirement from ISO 9001 or other regulation?

Does the document

Documents vs Records
A document is a living thing. The information contained within a document is subject to change; it can be revised. A record, on the other hand, is history. The information on a record cant be changed, because the record simply states what has already happened. Simply put, a record and a document are two completely different things.

APPROVE

Who What When Why

Controlled, documented and identified !!!!!

REVIEW
Use the internal audit process to review documents. Audits are samples
The standard implies that all documents must be reviewed.
If the organization intends to use its internal auditing process to satisfy this requirement, then extra care would need to be made during the scheduling and planning of audits to ensure that all documents are sampled over an extended period of time.

REVISION STATUS
Current revision of the document.
For paper-based documents, the revision status normally ties back to a master list or index that shows the current revision of all documents. For electronic documents, knowing the current revision is less important because the most current version is usually served automatically to all users. Either way, the revision status must still be identified.

ACCESSIBLE

A document is no use if it is not accessible.

ISO 9001:2008 requires that relevant versions of applicable documents are available at points of use.

This means that the most current version of documents are accessible by the people who need them
Know and demostrate how to access them

Simply Put

LEGIBLE

Legibility means that the documents can be read and understood.

Clear, Decipherable Language/format appropriate for the user

EXTERNAL
An external document is something that is

published outside the organization, but which is used by the organization within the scope of management system.

The questions listed will help determine if an external document should be controlled. organization;

Examples of controlled external documents

Troubleshooting and/or calibration manuals published by equipment manufacturers; Test procedures, specifications, and/or engineering drawings published by customers or other bodies; Instructions, specifications, and/or procedures published by suppliers; Standards published by industrial organizations applicable to the organization

What now?

Must be identified, and their distribution must be controlled. Must be reviewed when updated. This review must be documented. When PO calls out a specification a copy must be available as well as evidence of its review

DISTRIBUTION

By definition a controlled document has its distribution controlled

Knowing where they are located is critical to controlling the information contained on them. A distribution list simply defines the number of copies in existence and where they are located.

OBSOLETE
1)

their unintended use must be prevented they must be identified if they are retained.

2)

Keep it simple!!!!!!

FORMS
Forms must be controlled. The primary reason of having a form in the first place is to create consistency in the way that data is collected. Consistency can only be enforced when everybody is using the same form, and this is only achievable through some type of document control. Case closed.

ISO 9004 Guidance on Documentation (4.2)

The generation, use, and control of documentation should be evaluated with respect to the effectiveness and efficiency of the organization against criteria such as:

Functionality (e.g., speed of processing) User friendliness; Resources needed Policies and objectives Requirements for managing knowledge Benchmarking of documentation systems Interfaces used by customers, suppliers, and interested parties And, access for people in the organization and others should be based on

the organizations communication policy.

Enhancements

Use PDF for consistency, ease in printing and viewing and flexibility but most of all for change protection MS word for showing changes in documents Master lists with hyperlinks Access database

SUMMARY

BE CLEAR BE CONCISE BE VISUAL BE SIMPLE WRITE FOR THR READER NOT THE WRITER US COMMON SENSE. ASK WHAT IF I DONT? AND YOU WILL KNOW WHAT TO DO.

Questions?

Bibliography
Document Control 101 Copyright 2002 Craig Cochran Originally published in the June 2002 issue of Quality Digest ISO 9001.2008 PDF Advantages Over Word Documents By K.C. Winslow, eHow Contributor, last updated April 16, 2012