Procedure / Process Writing Information
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Responsibilities for Procedures:
Other considerations to incorporate in procedures:
Work Instructions vs. Procedures:
Responsibilities for Work Instructions:
Requirements of Work Instructions:
Work Instructions should specify:
Other considerations to incorporate in work instructions:
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ISO 9000 Procedure Writing Information
Procedure: A procedure (for purposes of the ISO 9001 implementation) is defined as a documented process for quality activities that are interdepartmental. The intent of the procedures are to be used as a reference where they will provide guidance and consistency when employees perform quality related tasks.
Responsibilities for
Procedures:
- Each department must be responsible for writing their procedures.
- Managers for the departments have approval of all procedures under their areas of responsibility.
- Procedures must be under some form of document control. (numbered, revision, signed & dated)
- Procedures should reference inner-related procedures and quality system documentation created from following the procedure.
- Quality Records as required by the ISO 9001 standard that are generated by a procedure or work instruction must be listed in a Quality Records Procedure (This is not always required by all registrar's, however, is a required by many and is appreciated.
- What should be done?
-
Who will do it?
- When will it be done and in what sequence?
- How will it be done?
- What equipment, tools or materials will be used?
- What forms or other documents will be used.?
- An appendix for all forms used in the procedure
- A flow chart for the procedure (where applicable the flow chart can be the procedure if it is understandable)
-
Signed, dated authorizations under revision control with controlled
distributions.
Other
considerations to incorporate in procedures:
- Definitions
- Referencing standards
- Safety or danger warnings related to the procedure
- Documentation
-
Quality Records
The Bottom Line:
For ISO or QS 9001 compliance, the bottom line is to write
what you do, then do what you have written.
Tip 1: The more general the procedure, the more flexible, however, the more specific the guidance, for those responsible for carrying out job duties, the easier the system is to maintain.
Tip 2: There must be at least one procedure for each element
for the standard, dependant upon complexity of the element. Writing separate
procedures for manageable activities will be less confusing than one grand
activity.
- Note: At this time all the elements are to be covered, however, as a company changes, it changes how it does, hence, the number of procedures may change.
Tip 3: A reference can be put into the procedures referencing
other procedures if you are documenting the elements other than by the ISO
Standard numbering scheme.
- Note: The systems currently set up by the author are done so that the Quality Manual references Quality System Procedures and the Quality System Procedures reference Departmental Work Instructions.
Tip 4: Try to keep the procedures from being to specific. Assign
who (by job title) does a task and when does it happen.
- Note: Specific instruction on how to do tasks are work instruction.
Tip 5: When assigning responsibility, the use of assignee, designee or successor following the title of the person responsible in the process will keep the process flexible and provide an option should the responsible person be unavailable at any specific time.
Tip 6: Keep the use of symbols minimized.
Tip 7: There must be consistency in action.
Tip 8: Use of a flow chart is not required, however, is highly
recommended. Visit the Flowcharting Help Page
(Tutorial) at
http://www.flowhelp.com/flowchart/flowchart.htm
for additional information on flow charts.
- Note: The reason flowcharting is recommended is that an auditor may chose to flow chart the procedure to check it out. He/she may make an error to the flow because of the complexity of the procedure which may not readily be found. This could be a problem if he/she determines there is a noncompliance and the error can't be found.
Work Instructions vs. Procedures:
Work instructions are another way of saying "procedure". Work
instructions are not as general as procedures and are very task specific.
They should tell how to do or use something (i.e. How to solder. How to use
loctite. How to assemble a Widget.).
Work Instruction: A work instruction (for purposes of quality system implementation) is defined as a documented process for quality activities that are intra-departmental. The intent of the work instructions are to be used as a reference where they will provide guidance and consistency when employees perform specific quality related tasks within a department.
Responsibilities
for Work Instructions:
- Each department must be responsible for writing their procedures.
- Managers/Supervisors for the departments have approval of all work instructions under their areas of responsibility.
Requirements of
Work Instructions:
Procedures and Work Instructions must be under some form of
document control by the generating department. (numbered, revision, signed
& dated, distribution maintained) Work Instructions should
reference related procedures and quality system documentation created from
following the procedure. Quality Records required by the ISO
9001 standard that are generated by a procedure or work instruction must
be listed in a Quality Records Procedure.
- Note 1: Quality Records are typically referenced in Quality System Procedures, but may be generated as a part of a work instruction. A separate Quality Records section is not required for work instructions provided general instruction exist within the Quality System Procedures that reference the record.
- Note 2: The Quality Records Element requires that records be listed. It is recommended to list them under under the appropriate ISO element within the Quality Records Procedure, list the proper name of the record, location where stored, person responsible for maintaining the record, by title and the retention period for the document.
Work Instructions
should specify:
- What should be done?
- Who will do it?
- When will it be done and in what sequence?
- How will it be done?
- What equipment or materials will be used?
- What forms or other documents will be used.?
- An appendix for all forms used in the procedure
- A flow chart for the procedure (where applicable the flow chart can be the procedure if it is understandable)
-
Signed, dated authorizations under revision control with controlled
distributions.
Other
considerations to incorporate in work instructions:
- Definitions
- Referencing standards
- Safety or danger warnings related to the procedure
- Documentation
- Quality Records
Other related web sites by the author as follows:
Flowcharting Help Page at http://www.flowhelp.com/flowchart/flowchart.htm
Job Descriptions Help Page at http://www.flowhelp.com/jobs/index.html
Integrating SOX-404 Internal Controls Auditing into ISO9001 at http://www.flowhelp.com/sox-404/
Program Management Tips at http://www.flowhelp.com/iso/program.html
Total Quality Management (TQM) Tutorial/Help Page at http://www.flowhelp.com/tqm/tqm.html
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Recommended Quality System Implementation Books
ISO 9000 Documentation, Quality Manual and 32 Operational Procedures (AQA ISO 9000 Series) by Jack Kanholm. Paperback
ISO 9000 In Our Company, Self-Study Course for Personnel (AQA ISO 9000 Series) by Jack Kanholm. Mass Market Paperback
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ISO 9000: 2000 (DIS) New Requirements, 28 Requirements Checklist and Compliance Guide -- Jack Kanholm; Paperback.
Tool Kit : Forms, Checklists, Project Planning Tools, Transparency Masters; Vincent Zottola; Card Edition This is a little more costly than the Jack Kanholm book, however, you don't have to create training materials.
List of Recommended Other Quality Books
QS-9000 In Our Company, Self-Study Course for Personnel (AQA QS-9000 Series) by Jack Kanholm. Mass Market
QS-9000 Requirements, 119 Requirements Checklist and Compliance Guide (AQA QS-9000 Series) -- Jack Kanholm; Hardcover
QS-9000 Documentation, Quality Manual and 43 Operational Procedures (AQA QS-9000 Series)
by Jack Kanholm. Paperback
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ISO 13485 (EN 46000) In Our Company, Self-Study Course for Personnel (AQA ISO 13485 (EN 46000) Series) by Jack Kanholm. Mass Market Paperback
ISO 13485 (EN 46000) Requirements, 99 Requirements Checklist and Compliance Guide (AQA ISO 13485 (EN 46000) Series) by Jack Kanholm, Lynette Howard. Hardcover
ISO 14000 In Our Company, Self-Study Course for Personnel (AQA ISO 14000 Series) by Jack Kanholm. Mass Market Paperback
ISO 14000 Requirements, 61 Requirements Checklist and Compliance Guide (AQA ISO 14000 Series) by Jack Kanholm. Hardcover
ISO 14000 Documentation, Environmental System Manual and 20 Operational Procedures (AQA ISO 14000 Series) by Jack Kanholm. Paperback
Quality Is Free : The Art of Making Quality Certain; This has it's fine points, however, can be dry. Best not taken in one or two sittings. Philip B. Crosby; Mass Market Paperback.
Quality Is Still Free : Making Quality Certain in Uncertain Times; Philip B. Crosby; Hardcover
Quality Is Free : The Art of Making Quality Certain; Philip B Crosby; Hardcover; (Special Order)
A History of Managing for Quality : The Evolution, Trends, and Future Directions of Managing for Quality; J.M. Juran (Editor); Hardcover
Juran on Leadership for Quality : An Executive Handbook; Joseph M. Juran; Hardcover
Juran on Quality by Design : The New Steps for Planning Quality into Goods and Services; Joseph M. Juran; Hardcover
Juran's Quality Control Handbook; Frank M. Gryna (Editor), J. M. Juran; Hardcover
Quality Planning and Analysis : From Product Development Through Use (Industrial Engineering and Management Science); J.M. Juran, Frank M. Gryna; Hardcover
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The 7 Habits of Highly Effective People : Powerful Lessons in Personal Change; A great book on how to get organized if your into self improvemnt and feel organizationally handicapped; Stephen R. Covey; Paperback
Critical Chain; A book dealing with supplier chains. Not too bad, but hard to find in a book store. Eliyahu M. Goldratt; Paperback
The Goal : A Process of Ongoing Improvement; One of the "Classics", used by practitioners and graduate schools alike. Eliyahu M. Goldratt, Jeff Cox; Paperback; $17.96
The Goal : A Process of Ongoing Improvement/Cassettes; For those who would rather listen while driving thier car, rather than read. Eliyashu M. Goldratt, et al; Audio
List of Recommended Humorous Management Books (Humor for the those who have been there.)
Dogbert's Top Secret Management Handbook; If you need a little humor in your life, you can also visit Scott Adam's at his Web Site http://www.dilbert.com/ for a daily dose. Scott Adams; Hardcover; Published 1996
Access Denied : Dilbert's Quest for Love in the Nineties; Scott Adams; Hardcover;
Always Postpone Meetings With Time Wasting Morons; Scott Adams; Paperback; Published 1994
Access Denied : Dilbert's Quest for Love in the Nineties; Scott Adams; Hardcover
Always Postpone Meetings With Time Wasting Morons; Scott Adams; Paperback; Published 1994
The Boss : Nameless, Blameless and Shameless ;Scott Adams; Hardcover; Published 1997
Bring Me the Head of Willy the Mailboy!; Scott Adams;Paperback; Published 1995
Casual Day Has Gone Too Far : A Dilbert Book; Scott Adams; Paperback; Published 1997
Conversations With Dogbert (Dilbert Book); Scott Adams; Hardcover; Published 1996
The Dilbert Principle : A Cubicle'S-Eye View of Bosses, Meetings, Management Fads & Other Workplace Afflictions; Scott Adams; Paperback; Published 1997
The Dilbert Principle : A Cubicle's Eye View of Bosses, Meetings, Management Fads, & Other Workplace Afflictions / Audio Cassette / Abridged; Scott Adams; Audio Cassette; Published 1996
Dilbert : A Book of Postcards; Scott Adams; Paperback; Published 1996
The Dilbert Future : Thriving on Stupidity in the 21st Century; Scott Adams (Narrator); Audio Cassette; Published 1997
The Dilbert Future : Thriving on Stupidity in the 21st Century; Scott Adams; Hardcover; Published 1997
The Dilbert Principle : A Cubicle's-Eye View of Bosses, Meetings, Management Fads & Other Workplace Afflictions; Scott Adams; Hardcover; Published 1996
Dogbert's Clues for the Clueless; Scott Adams; Paperback; Published 1993
Dogbert's Top Secret Management Handbook; Scott Adams;Audio Cassette; Published 1996
Fugitive from the Cubicle Police : A Dilbert Book (Adams, Scott, Dilbert Book.); Scott Adams; Paperback ; Published 1996
It's Obvious You Won't Survive by Your Wits Alone : A Dilbert Book (Adams, Scott, Dilbert Book.); Scott Adams; Paperback; Published 1995
Shave the Whales (A Dilbert Book); Scott Adams; Paperback; Published 1994
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