PCB007 Magazine

PCB007-July2020

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88 PCB007 MAGAZINE I JUNE 2020 The goal of the runner is a rapid response and one-touch of all documents and depart- ments by satisfying all auditor needs, requests, and questions before moving on to another ar- ea. The runner is a key strategy to support the guerrilla tactical strategy of getting in and out. Examples 1. Auditor issue: Observes an operator imag- ing panels. Auditor: "How do I know this person has been properly trained to perform this operation?" Rapid response: As the employee is explain- ing their training status to the auditor (badge, color code, matrix, etc.), the runner should re- trieve the employee's training record and certi- fied operator test to present to the auditor on the spot—signed, sealed and delivered. 2. Auditor issue: Observes a machinist mea- suring 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 certifica- tion and NIST traceability records to present to the auditor on the spot. Instant Gratification Collateral benefits of the runner strategy in- clude that it demonstrates competence at the operator level, system robustness, manage- ment commitment, and quality system com- pliance. It also supports employee interaction, fosters teamwork, and instills auditor confi- dence. 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 ra- tionale and rules for its use. If an error and/or omission is identified by an auditor, utilizing the page swap technique to immediately cor- rect 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 rea- son that key employees and procedure signato- ries must be present and available for all major audits and customer visits. The ability to rap- idly change, approve, and distribute a proce- dure 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 neces- sary 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 ad- dressed 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 sig-

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