8.7 Hosting the Customer Audit

8.7.1 Audit Strategy: The "War Room" Protocol

When a customer or regulatory body (FDA, ISO Registrar) audits the facility, success relies on controlling the flow of information. The audit is a formal examination, not a casual tour.

The "Front Room" vs. "Back Room" Architecture

• The Front Room: This is where the Auditor sits. It should be clean, sparse, and devoid of any loose papers. Only the Audit Host and the necessary Subject Matter Expert (SME) are allowed here.
• The Back Room (War Room): This is the command center. It is staffed by scribes, document runners, and Quality Engineers.
  • The Scribe: Sits in the Front Room (silently) and types every question the auditor asks into a live chat channel displayed in the Back Room.
  • The Runner: In the Back Room, sees the request (e.g., "Show me the training record for Operator A"), retrieves the document, reviews it for errors, and walks it into the Front Room.
  • The Filter: Never hand a document to an auditor without reviewing it first. If a record has a missing signature, fix it (via proper Good Documentation Practices) or be prepared to explain it before the auditor sees it.

Audit Etiquette for Floor Staff Every employee must be trained on how to answer an auditor. The golden rule is: "Answer only the question asked."

• Auditor: "Do you calibrate this torque driver?"
• Bad Answer: "Yes, we do it every Tuesday, but sometimes Bob forgets because he's busy, so we do it Wednesday." (This volunteers a non-conformance).
• Good Answer: "Yes." (Wait for the next question).
• Auditor: "Can you show me the sticker?"
• Good Answer: (Points to sticker).

8.7.2 The Self-Audit Checklist (The "Pre-Flight" Check)

Before the auditor arrives, the site must conduct a "Clean Sweep" self-audit. This checklist mimics the most common findings from ISO and Customer audits.

Facility & Infrastructure

• [ ] Are all ESD wrist strap testers calibrated and plugged in?
• [ ] Are fire extinguishers unblocked and inspected?
• [ ] Are all chemical bottles (IPA, Flux) labeled with contents and hazard warnings (GHS)?
• [ ] Is the "Red Tag" quarantine cage locked?

Production Line

• [ ] Are Work Instructions (WI) at the latest revision? (Check the revision date against the master list).
• [ ] Are there any "rogue documents" (post-it notes, cheat sheets) taped to machines? Remove them immediately.
• [ ] Are all torque drivers and calipers within their calibration date?
• [ ] Are personal items (food, drinks, bags) removed from the ESD Protected Area (EPA)?

Documentation

• [ ] Are training records signed and up-to-date for every operator on the line today?
• [ ] Are reflow oven profiles from the last shift saved and compliant?
• [ ] Is the Maintenance Log for the SMT machine filled out for yesterday?

8.7.3 The Audit Closing Meeting

The audit concludes with a Closing Meeting where findings are presented.

• The Rule of No Surprises: The Audit Host should have a pulse on every finding before this meeting.
• Accepting Findings: Acknowledge valid non-conformances professionally. Do not argue about feelings; argue only facts. If the auditor claims a record is missing, but you found it in the Back Room, produce it immediately to downgrade the finding.
• The Recovery Plan: State clearly that a CAPA plan will be issued within the agreed timeframe (usually 5-10 business days).

Final Checklist