Guerrilla Tactics to Pass any QMS Audit – Tactic 9 Tips To Avoid Audit “Dings”

Williams’ Law 9

Teach it, preach it, and audit to it! Prepare so that no question should be able to be asked that an operator does not know the answer to.

Guerrilla Tactic 9: QMS Documentation Tips To Avoid Audit “Dings”

Tip 1: KISS

Keep It Simple Steve; the goal is to develop a system that is:

• Value-adding to the organization
• Easy to understand
• Flexible
• Reducing opportunites for error
• SIMPLE

Tip 2: Standardization

Develop standardized QMS procedure template

• Standardize sections e.g.:
  • Scope
  • Responsibilities
  • Terms & Definitions
  • Instructions
  • Reference Documents
  • …etc.

Facilitates:

• Ease-of-use
• Training
• Recall
• Memorization of “structure”, not procedure
• Time-to-retrieval

Tip 3: Verbiage

• “Functional Vagueness”
  • Precise enough for functionality
  • Vague enough for practicality
• “Shall/Must”
  • Critical
  • Non-compliance would jeopardize operation
• “Should/May”
  • Non-critical
  • Non-compliance would not jeopardize operation
  • Leaves room for external circumstances

Examples

“Bath pH shall be verified and logged onto form 203-004 every 2 hours.”

“Workplace should be kept clean on a continual basis.”

Designee

• Try to always use this term
• Don’t: “The Molding Supervisor shall review & sign-off on the daily SPC results.”
• Do: “The Molding Supervisor, or his/her designee, shall review & sign-off on the daily SPC results.”

Contact TRAC

Contact me to start your Quality Management System Guerrilla Training before your next audit.

Steve: 920-841-3478

Steve@tracQMS.com