KGMP Audit Readiness: 8-Week Sprint Plan and Document Checklist

What This Template Includes

An 8-week project plan that takes a manufacturing site from "have an ISO 13485 QMS" to "audit-ready for KGMP," including:

• Week-by-week milestone plan with deliverables and responsible parties.
• Master document checklist organized by KGMP audit chapter.
• Mock audit script with 30 sample questions auditors typically ask, by area.
• Findings response template for the 48-hour window after the audit closing meeting.
• Korean-language audit-day glossary of 80 key regulatory terms.

The template is structured for foreign manufacturers — typically based in the US, EU, Japan, or Southeast Asia — preparing their first KGMP audit through an accredited Korean certification body.

Who This Is For

• Quality and Regulatory leads at manufacturers with existing ISO 13485 certification, preparing for first-time KGMP certification audit
• Sites preparing for the 3-year surveillance audit between certification cycles
• Sites under remediation after a KGMP non-conformity finding
• KLHs supporting their first foreign-manufacturer audit on the Korean side

The 8-Week Sprint

Week 1 — Gap Assessment

Compare current QMS against KGMP requirements using the included gap checklist. Identify:

• Procedures present in ISO 13485 but requiring Korean overlay (complaint handling, label changes, import records)
• Procedures absent entirely (Korean adverse event reporting, KLH coordination, MFDS notification triggers)
• Documents existing only in English but needed in Korean (Quality Manual translation/adaptation)

Output: a prioritized remediation list with owners and target dates.

Week 2 — Korean Quality Manual

Draft the Korean Quality Manual as a standalone document, not a translation of the master manual. The KGMP Quality Manual references Korean regulations, Korean reporting channels, and the KLH relationship. Auditors specifically look for the Korean Quality Manual at audit opening — its absence triggers immediate concern.

Week 3 — Procedure Overlays

Add Korean-specific procedures or annexes:

• Import record procedure (KLH-side traceability)
• Korean complaint routing procedure
• MFDS adverse event reporting procedure (7/15/30 day clocks)
• Korean labeling change notification procedure
• KGMP surveillance and re-certification procedure

These overlays sit on top of existing ISO 13485 procedures, not replacing them.

Week 4 — Document Translation and Korean Working Set

Translate critical documents into Korean. Not the entire QMS — just the audit-relevant working set:

• Quality Manual (Korean)
• Top-level procedures listed in the audit scope (Korean)
• Form templates that auditors will request samples of (bilingual)
• Recent CAPAs related to Korean market (bilingual)

The translation is a one-time investment. Once done, only changes need re-translation.

Week 5 — Mock Audit

Run a full mock audit using the included script. Allocate 1.5 days. Three components:

1. Document review (half day) — auditor sample-pulls procedures, records, forms.
2. Process walkthroughs (half day) — design, production, supplier, post-market.
3. Personnel interviews (half day) — quality manager, design lead, complaint handler, manufacturing operator.

The mock audit produces a findings list. Treat findings like real findings — they are the rehearsal for the actual response window.

Week 6 — Remediation

Close the mock-audit findings. Update procedures, retrain personnel, generate the missing records. This is the work that distinguishes audit-ready sites from those that scramble during the real audit.

Week 7 — Audit Logistics

• Confirm interpreter arrangements
• Prepare the audit room with quick access to records (paper or digital)
• Brief the personnel who will be interviewed
• Print the bilingual glossary for the audit team
• Prepare the welcome packet for auditors (site map, organization chart, key personnel directory)
• Verify the KLH representative is confirmed and briefed

Week 8 — Final Readiness Check

A 1-day final readiness review using a stripped-down version of the mock audit script. Focus on the three areas auditors most commonly find issues:

• Design control linkage from hazards to verification
• Supplier control (top three suppliers' audit records)
• Sterilization validation reports (full reports, not certificates)

If any of these surface gaps in Week 8, escalate to a contingency response plan rather than entering the audit blind.

Document Checklist (Summary)

The full checklist in the template covers 14 chapters and ~85 specific document requirements. Top-level categories:

Chapter	Document Count	Owner
Quality Management System	8	QA
Management Responsibility	5	QA / Mgmt
Resource Management	6	HR / QA
Product Realization	18	R&D / Mfg
Design Controls	12	R&D
Production Controls	14	Mfg
Measurement & Calibration	7	Mfg / QA
Supplier Management	5	Procurement / QA
Complaint Handling	4	QA / KLH
CAPA	3	QA
Adverse Event Reporting	3	RA / KLH
Post-Market Surveillance	4	RA
KLH Coordination	4	RA / KLH
Korean Labeling	6	Marketing / RA

Audit Day Behavior

A short guide to what works in the audit room and what does not.

Works:

• Direct, concise answers. "Yes, that procedure exists. Here it is."
• Pulling the record when requested, within 15 minutes.
• Acknowledging an issue if one is found — auditors respond well to ownership.
• Having the Korean version of every procedure ready, even if the English version is the working version.

Does not work:

• Explaining at length why a finding is not really a finding.
• Producing records that were created after the audit notice arrived.
• Arguing about whether a Korean-specific requirement applies "in our system."
• Letting the manufacturer's quality manager and the KLH representative give contradictory answers to the same question.

The 48-Hour Findings Response

Korean audit closing meetings typically end with a verbal findings summary, followed by a written report 5–10 business days later. The 48 hours between the closing meeting and the formal findings is the highest-leverage window. During this window:

1. Re-pull the records auditors looked at; verify your recall matches reality.
2. Draft factual clarifications for any findings that may be based on misunderstanding.
3. Identify the corrective action owner for each finding.
4. Submit factual clarifications to the lead auditor before the written report is finalized.

The included response template structures this 48-hour window.

Common Surveillance Audit Findings

For sites already certified, surveillance audits typically generate 3–7 findings. The recurring themes:

1. Stale CAPAs — CAPAs open longer than 90 days without documented progress.
2. Weak supplier audit cadence — suppliers on the approved list without recent audit records.
3. Missing labeling change notifications — minor labeling changes made without MFDS notification.
4. Untranslated complaint records — Korean-language complaints sitting in the KLH inbox untranslated.
5. Surveillance plan not executed — PMS plan exists on paper but no analysis cycles documented.

Download

Download the 8-Week Sprint Plan PDF — free, includes editable Word templates for the findings response and Korean Quality Manual outline.

Where Leanabl Plugs In

For sites that want hands-on audit preparation rather than self-directed sprint execution, the Korea Audit Readiness service runs the 8-week plan with a Korean RA lead embedded on-site. The full KGMP Certification program is recommended for first-time certifications. Ongoing surveillance audits are typically handled through Korea License Maintenance.