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Estimated reading time: 5 minutes
The Right Approach: Guerilla Tactics to Pass Any QMS Audit, Part 4
Concluding this four-part series on “Guerilla Tactics to Pass Any QMS Audit,” I will share Tactic 10. Hopefully, through this series, you found a number of solid strategies you could apply immediately to improve your audit success.
Guerrilla Tactic 10 Techniques to Reverse a Finding
Williams’ Law 10: The more wins you can bank with an auditor/customer, the greater the chance they will write off a negative observation as an isolated anomaly.
Williams’ Law 10.5: The more findings an auditor/customer identifies, the deeper they will dig into all subsequent areas.
The key to reversing an auditor’s finding is on-the-spot corrective action. Responsive, ultra-prompt action is required as well as the aforementioned political savvy of the management representative in administering the following techniques.
The Runner Strategy
The concept of “the runner” is somewhat of a super-secret weapon to be used during any formal audit. It’s not so much a formal position as it is a relationship between the management representative and the person filling the role of the runner. The runner needs to be someone who is extremely familiar with all aspects of the quality system. The ideal person for this role is the quality analyst (ISO coordinator, quality systems administrator, etc.), which is the position responsible for the administration of the quality management system. With a seasoned team, the management representative and the runner will develop a set of “silent codes” between themselves; something as simple as eye contact could send the runner to retrieve some supporting documentation to satisfy an auditor’s request.
The purpose of the runner is to maintain a clean record as the audit progresses by supplying real-time supporting information, records, or any other proof of execution that the auditor may request. Most companies typically handle this by having the management representative/escort compile a long laundry list that the auditor asked to see during the tour that would need to be reviewed and/or verified at the end of the audit. This approach invariably results in findings and/or observations due to a variety of reasons, including time constraints, disagreement on the original request, and flat out just forgetting to address all the issues.
The goal of the runner is a rapid response and one-touch of all documents and departments by satisfying all auditor needs, requests, and questions before moving on to another area. The runner is a key strategy to support the guerrilla tactical strategy of getting in and out.
Examples
1. Auditor issue: Observes an operator imaging panels.
Auditor: “How do I know this person has been properly trained to perform this operation?”
Rapid response: As the employee is explaining their training status to the auditor (badge, color code, matrix, etc.), the runner should retrieve the employee’s training record and certified operator test to present to the auditor on the spot—signed, sealed and delivered.
2. Auditor issue: Observes a machinist measuring dimensions.
Auditor: “How do I know that instrument is accurate?”
Rapid response: As the employee is showing the auditor the calibration sticker on the tool and explaining the tool calibration system, the runner should retrieve the calibration certification and NIST traceability records to present to the auditor on the spot.
Instant Gratification
Collateral benefits of the runner strategy include that it demonstrates competence at the operator level, system robustness, management commitment, and quality system compliance. It also supports employee interaction, fosters teamwork, and instills auditor confidence.
The Page Swap Technique
The page swap technique can be employed to correct minor mistakes or omissions in a procedure. This technique is perfectly legal as long as there is a page swap clause in your document control procedure outlining the rationale and rules for its use. If an error and/or omission is identified by an auditor, utilizing the page swap technique to immediately correct the error and present the auditor with a corrected procedure before he/she finishes the audit will generally result in a non-finding.
Situations that allow a page swap include when:
- You can swap a single page in a procedure
- Re-approval of the entire procedure is not required
- Page content integrity remains intact
- Page numbering does not change
- There are typos
- There are minor wording changes
- There’s a missing word/phrase
- Obvious intent was implied
Procedure Revision
On-the-spot procedure revisions are the reason that key employees and procedure signatories must be present and available for all major audits and customer visits. The ability to rapidly change, approve, and distribute a procedure revision in reaction to an auditor’s finding will be the difference between a formal finding and a clean audit.
Examples
1. Auditor issue: Identifies an omission or a typo in a procedure.
Rapid response pages swap: Tell the auditor that the changes are being made and that you will revisit with them promptly. As an audit is continued, the runner should make the necessary changes via a page swap and catch up with the auditor to present the revised page, also presenting the auditor with the approved document control procedure and explaining the page swap clause. One touch!
2. Auditor Issue: Identifies an issue not addressed in the procedure but being performed by the operator.
Rapid response revision: Tell the auditor the changes are being made and will revisit with him/her promptly. As the audit is continued, the runner should have the necessary changes made to the procedure, changing the revision on the procedure and the master document list (MDL) and hand-carrying the new procedure to secure a signature from each procedure signatory. The runner catches up with the auditor and presents the revised and approved procedure to the auditor, along with the MDL.
Top 10 Auditor Hot Buttons
These auditor hot buttons should be included in the internal audit program and be part of the scavenger hunt activity during the ISO rallies.
Conclusion
It is my hope, should you survive all four installments of this series, that you will have found a few helpful takeaways in the development or improvement of your own quality system and internal audit program. The strategies, techniques, and tactics presented throughout this series are tried-and-true, practical applications with lessons learned over the course of my career that I hope you will find some value in. As you go through your quality journey, I will remind you to always remember Williams’ Master Law.
Williams’ Master Law: It’s always about the dollars!
I would argue that any pursuit can, and will, be quantified by cost. In other words, it must make financial sense. I believe you will find that everything we have discussed in this series makes perfect sense from both a practical and financial perspective.
Editor’s note: Read Part 1, Part 2, and Part 3.
This column originally appeared in the July 2020 issue of PCB007 Magazine.
More Columns from The Right Approach
The Right Approach: I Hear the Train A Comin'The Right Approach: Culture Change is Key to a QMS
The Right Approach: Leadership 101—Be a Heretic, Not a Sheep
The Right Approach: Leadership 101—The Law of Legacy
The Right Approach: Leadership 101: The Law of Explosive Growth
The Right Approach: Leadership 101—The Law of Timing
The Right Approach: The Law of Sacrifice
The Right Approach: The Law of Priorities