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/index.html
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:
Performance Appraisal Tips Help Page
This page is linked to Amazon.com' flowcharting
books. Click on books of interest for additional
information or to order.
There are a number of professions that use flowcharting. The list below includes various books on flowcharting as well as several on VISIO, one of the most used programs for flowcharting.
Flowcharting Help Page List of Recommended Flowcharting Books
The Basics of Process
Mapping 2nd Edition by Robert Damelio (Author) Kindle Hardcover
Paperback
Go With the Flow!:
The Clutter Flow Chart Workbook – January
20, 2023
by Hazel Thornton Paperback
Flowcharts Usage:
Get An Introduction To The Use Of Flowcharts As A
Process Design – December 23, 2022
by Irving Brangan) Paperback
MICROSOFT VISIO USER
GUIDE: THE COMPLETE GUIDE FOR BEGINNERS AND EXPERTS
TO MASTER VISIO DIAGRAMS by TIM VEGA | Dec 14,
2023
Paperback
Visualize Complex
Processes with Microsoft Visio: A guide to visually
creating, communicating, and collaborating business
processes efficiently
by David J Parker and Senaj Lelic | May 12, 2023 Kindle Paperback
Free Diagram & Flowchart Software
for Mac for Chart Drawing and Creation,
Mac Download
PC Download
