Flowhelp.com's Procedure / Process Writing Tips

Procedure / Process Writing Information

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ISO Procedure Definition:

Responsibilities for Procedures:

Requirements of Procedures:

Procedures should specify:

Other considerations to incorporate in procedures:

The Bottom Line:

Tips on Procedures:

Work Instructions vs. Procedures:

Work Instruction Definition:

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.

Requirements of Procedures:

  • 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.

Procedures 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, 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.

Tips on Procedures:

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:

Flowcharting Help Page   

Job Descriptions Help Page 

Performance Appraisal Tips Help Page

Program Management Tips 

Total Quality Management (TQM) Tutorial/Help Page 

Procedure / Process Writing Tips 

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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
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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

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Dexter A. Hansen