The Value of Well-Written Documentation

 Sustaining Edge Solutions, Inc. Newsletter

Performance Improvement Solutions for Your Business                                     August 2013


This Month
* Value of Documentation
* Need for Work Instructions
* Auditing Customer Property
* In the News
* Training Courses



Phoenix ASQ Chapter General Session Meeting Sept 12, 2013. Cost of Poor Quality-Walter Tighe, Speaker
ASQ Audit Division and Quality Management Division Conference  Oct 10-11, 2013 Tucson, AZ.  We are a Silver Sponsor and Exhibitor of this Conference.  See you there!      

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Our newsletters provide information on business management systems.  These systems include ISO 9001 QMS, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  Subjects include performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

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The Value of Well-Written Documentation            

No matter what your type of business, operating procedures and work instructions exist. Without them your business would be in chaos. Companies registered to international standards such as ISO 9001, know the benefits of what a well written procedure and work instruction can do; reduce process variation, provide employee clarity and understanding of “who” does “what” and, if applicable “when” and “where.”   These are what a procedure should explain. The following recommendations will allow for an efficient and employee useful procedure.  

* Although there may be a few exceptions, most procedures shouldn’t exceed four pages. The actual procedure should start with page 1, not on the second or later. You should never have redundant statements within a procedure or between procedures and/or work instructions.

* Procedures should refer to the appropriate documents (e.g. other procedures, Work Instructions) or forms within the body of the procedure.

* Make your forms self-explanatory and if needed, insert examples.

* Eliminate policy. This is a procedure. Policy isn’t needed here; you already covered it in the quality manual, level 1 policies.

* Vocabulary / Definitions / Abbreviations: These can be addressed in the body of the procedure. When the user is reading the word or phrase in the specific area of concern, understanding and learning of these takes shape much better than having a laundry list as an appendix.  

* Procedures can contain electronic linkages to other documents (fact is, your entire documented system should) so that, if necessary, the user is only a click away from reading them and using the right stuff.

* Insert responsibilities into the body of the procedure where the responsibilities are intended to be. Remember, your process as a flow from one action to the next. Having a list of responsible individuals/departments at the start of a procedure invites confusion and lack of organizational accountability. 

* Include the Purpose, Scope, and Procedure (consisting of responsibility and action), and revision record in the procedure.  Having a single laundry list of revisions on a separate document invites errors.


* Procedures should be subject to document control which includes approval, review, revision, issuance.


After Writing a Procedure Consider the Following:  


* Can the procedure be performed in the sequence it is defined?


* Can the user of the procedure locate and identify all the associated documents defined in the procedure?


* Can the user use the procedure effectively without needing direct assistance from someone else?     


* Do words, phrases, and language used have a unique meaning to the procedure and the user?


* Are there any needs for special consideration of data collection and record keeping?


Have any of your own procedure suggestions? Share with us!  We will include them in our next newsletter.  



The Need for Work Instructions          


Work instructions and workmanship standards can be in the form of manuals, procedures, standards, data sheets, posted signs, photographs, product and material samples, and other such written documents and physical samples. External documents, such as published standards or equipment manufacturer manuals, may be also used as work instructions.

Work Instructions tell how to carry out a process or perform a task. They can instruct on how to set up and operate process equipment; change and inspect tooling; feed, fasten or handle materials; carry out an inspection or test; or calibrate a measuring instrument.

Work instructions may also relate to administrative and other nonproduction tasks. For example, they may instruct on how to operate a computer program, enter an order, receive a shipment, and file a drawing, and conduct training. Work instructions may be issued by any department or function, and may apply to any process or task.

The need for work instructions and workmanship standards for a given production process is determined on the basis of the following considerations:


  • Ability to verify results of the process: Work instructions are effective for special processes, i.e., those processes the results of which cannot be fully verified by subsequent nondestructive inspections (such as welding, plating, painting, casting, cleaning, etc.). 
  • Importance of the process: Work instructions are effective for processes that are critical to the safety, fit, and function of the product. This may include packaging operations.
  • Complexity of the process: Work instructions are effective for processes where various process parameters must be set up and/or maintained at specified levels; where operators are required to program the process equipment; where tool changes are involved; or where, for any other reason, operation of the process is fairly complex and requires specific process setup instructions and/or operating data.
  • Process operator qualifications: Process operator qualifications, experience, and training are considered in determining whether work instructions are required, and how detailed they ought to be. Qualification and training of all designated operators, including other shifts and possible replacements, are considered.
  • History of quality problems: Work instructions may be required for processes that have a history of quality problems, especially when these problems can be associated with the lack of adequate instructions.


Work instructions are often developed for specific user groups. There may be separate work instructions for others. Each work instruction would only contain information that is relevant to each user group. This approach ensures that staff is not overloaded with information – they only know what they need to know.


Features of well written work instructions include:

* Less is more – avoid excessive wordage. Pictures in work instructions are effective.

* Include document control – who generated the document, when the document was printed

* Written by users – they are the obvious experts on “the how”

* Easily understood – test them on other users. 


Have any of your own work instruction suggestions? Share with us! We will include them in our next newsletter.  



Auditing 7.5.4 Customer Property          


Customer property (intellectual property) controlled by a bank.  

Situation: A bank provides a variety of services to its customers (i.e. personal and company bank accounts), but chooses to implement a QMS only for its Internet banking services. For this service the bank has claimed conformity to ISO 9001:2008. The bank clearly states in its Quality Manual which services are covered by the QMS. The bank applies all the requirements of ISO 9001:2008 for the realization of its Internet banking services, with the exception of sub-clause 7.5.4 Customer property. The bank does not feel that it has possession of any customer property as part of its Internet banking services and has stated this in the justification for the exclusion of sub-clause 7.5.4 Customer property from its QMS. 

Issue: Can the bank exclude sub-clause 7.5.4 Customer property from its QMS and claim conformity to ISO 9001:2008?  


Analysis and Conclusion: The decision made by the bank to exclude sub-clause 7.5.4 Customer property was not justified because the bank does receive information from its customers such as personal and confidential data. ISO 9001, 7.5.4 Customer property requires an organization to exercise care with customer property while it is under the organization’s control or being used by the organization (Note: this can also mean returned nonconforming product from a customer).

And the note of sub-clause 7.5.4 Customer Property, clearly indicates “Customer property can include intellectual property and personal data”. In this situation, the bank’s customers provide important information in confidence when using the service, which constitutes “Customer property”. Therefore the bank has to address the requirements for customer property in its QMS.


Internal auditing methods and techniques are always of interest to our readers and our clients. We will continue this discussion around further scenarios next month.  This could be fun!    


In the News      
The ASQ Joint Audit Division and Quality Management Division Conference will be held in Tucson, Arizona (our home state) on October 10-11, 2013. You can view the program and four tracks of presentations at this web page. You can register for the conference at this web page.

We are a Silver Sponsor of this Conference and will be Exhibiting!

Drop by our booth for free quality swag, process improvement information, and discounts on our all our training courses and business improvement methods! We look forward to seeing many of our clients, newsletter readers, and meeting you.


Boeing to Require AS9120A Certification for Suppliers


In a letter issued May 15, 2013, The Boeing Company will require distributors to be certified to the AS9120A standard “Quality Management Systems -Requirements for Aviation, Space and Defense Distributors” by an accredited Certification Body, like NQA, by June 30, 2014.”  Certification to this standard will be required for all distributors that wish to continue doing business with The Boeing Company after that date.  It should be noted that companies that are certified to the AS9100C standard meet this requirement as an acceptable alternative to AS9120A certification.

In addition, distributors that perform or outsource manufacturing or fabrication processes or perform value added services must be certified to AS9100C.

Training Courses

To see the course description, schedule, and on-line registration click on the course title below. We deliver onsite training for all these courses and customized training to fit your specific needs.  We offer group discounts.  


View all our Courses

View Our Web Based E-Training Courses   

ISO 9001 Quality Management

Understanding and Implementing ISO9001:2008

ISO 9001:2008 Process Based Internal Auditor 

Documenting Your Management System

AS9100 Aviation, Space and Defense

Understanding and Implementing AS9100C (9110 &9120) Aviation, Space and Defense

AS9100C:2009 Process Based Internal Auditor

Documenting Your Management System 

ISO/TS 16949 Automotive

Understanding and Implementing ISO/TS16949:2009 Automotive

ISO/TS16949:2009 Process Based Internal Auditor
Documenting Your Management System 

ISO 14001 Environmental

Understanding and Implementing ISO14001:2004 Environmental
ISO14001:2004 Process Based Internal Auditor

Lean Enterprise and CI 

5S Five Pillars of a Lean Workplace Organization
Continuous Process Improvement
Lean Six Sigma
8 Disciplines (8D) of Problem Solving

ISO 13485 Medical Devices

Understanding and Implementing ISO 13485:2003 Medical Devices
ISO 13485 Process Based Internal Auditor 

ISO 27001 Information Security

Understanding and Implementing ISO 27001:2005 Information Security
ISO 27001 Process Based Internal Auditor 

All courses can be delivered at your company. Don’t see a course, location, or date that fits your needs?

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