Tip 3: Verbiage
Consider verbiage as follows:

• Functional vagueness 
• Precise enough for functionality 
• Vague enough for practicality 

• Shall/must 
•   Critical 
•   Non-compliance would jeopardize operation 

Further, always use the term “designee.” For example:

Tip 4: Intelligent Conventions
If you are certified to an international QMS standard, such as ISO 9001 or AS9100, now that the powers that be have “harmonized” the standards, it is a great idea to number your system to align with the standard. For example, procedures, work instructions, forms, and attachments are numbered using the following number scheme with the prefix representing the type of document:

Some examples include:

This makes it easy to identify all forms associated with each procedure or work instruction. Also, try to avoid an automatic sequential numbering scheme (QP 102345C) and large procedure numbers.

Tip 5: Reference Documents
Add a “reference documents” section to every procedure:

Tip 6: Purge Control
Develop a control mechanism for revision purges. Don’t take a “hands-off” approach and assume individual departments will effectively purge.

Tip 7: Keep Six Months of Quality Records at the Work Source
Have posted procedures at the work source (paper or electronic). For instance, a 3” binder will easily hold 180 pages (six months). This allows quick and easy access and retrieval, calibrates with six-month surveillance audits, and provides finite history to verify.

Tip 8: ‘Outlaw’ White-Out
Do not allow White-Out in the facility. You can write exceptions into document control procedures for correspondence if absolutely necessary. Have a “controlled substance” mentality; it’s a simple matter of discipline. Teach “line, sign, date” (LSD) and audit to it internally

Tip 9: Eliminate Blanks
Issue edict: No forms shall have blanks. If a form has a section no longer used, remove it and revise the form. For instance:

Tip 10: Include All Forms
All forms should be included in the document control system (manufacturing, office, etc.). Preventive maintenance forms/logs are often overlooked and should be posted at the equipment and highly visible. Forms are quality records, and you would be hard-pressed to find an example that doesn’t contribute to the quality of the product in some form or another.

Tip 11: Resolve All Temporary Process Changes
Use three-month or six-month durations to sync with ISO surveillance audits. Try to resolve all TPCs prior to surveillance audits. If they can’t, or for customer audits, review the entire list of TPCs to make sure they are not expired. Also, verify that all resolved TPCs have been closed out appropriately (i.e., approved with appropriate procedure revision and unapproved with documented reason). 

Tip 12: Procedure Revision
Procedure revisions show an auditor that continuous improvement is happening. A red flag to most auditors are procedures that were written five years ago and have not been revised since. For example: 

Don’t forget forms that may need revision accordingly, and don’t go overboard on revisions. Use a temporary process change process to combine multiple small changes.

Conclusion 

It is my desire that as we work through the various strategies, techniques, and tactics presented throughout this series, you will appreciate these are tried-and-true, practical applications and lessons learned over the course of my career. I hope you will find some value in them.