21e Iso 9000 and Document Control
Transcript of 21e Iso 9000 and Document Control
Document Control for ISO 9001.2008
Beyond Efficiency
Session 21E
Barbara Butrym [email protected]
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: [email protected]
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 organization’s 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 what’s 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
Initial and date the
entry
the authorized user
or
company president
Log the change
onto the Change
control log in the
control book
Return the
control book to
the control area
Are there more than 5
changes since the last
update of the
procedure?
Yes
No
Doc control will
make the changes
to the procedure
and update the
control book and
any copies
Initiate
QF305-1
is this a major
process change?No
Yes
Change to a procedure or form D305-001 revision issue
Notifications
needed?
Notify or train
affected partiesYes
No
Are there any
other controlled
copies?
Make same
change to All
Control copies
No
Yes
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?
Does the document …… 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?
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 can’t 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
Simply Put Know and demostrate how to access them
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 it’s 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
2) they must be identified if they are
retained.
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 organization’s 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 DON’T? 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