Independent eyes on your quality system
Audit-ready, inspection-proof.
FDA, ISO certification bodies and your customers all expect regular, independent audits. JJCC Group audits your system, your suppliers and your readiness for certification. Our founder has led hundreds of facility audits across every major FDA-regulated sector.
Audit-ready, inspection-proof.
JJCC Group conducts independent, evidence-based quality audits against the regulations and standards that govern dietary supplements, food, pharmaceuticals, and medical devices — and walks alongside you to close every finding.
From a focused gap analysis to a full FDA mock inspection, our engagements are scoped to expose risk before a regulator ever does. Every audit is conducted by lead auditors drawn from former industry quality leadership and regulatory professionals familiar with FDA inspection technique.
This document outlines the regulations and standards we audit against, our four-pillar methodology, what to expect during a typical engagement, how to prepare your organization, and how we help bring you into demonstrable compliance after the report is delivered.
Regulations & standards we audit against.
Whether you operate under FDA jurisdiction, pursue ISO certification, or supply customers who require both, JJCC Group’s audit practice is built around the frameworks that actually drive enforcement and market access.
Dietary Supplement CGMP
Current Good Manufacturing Practice for the manufacturing, packaging, labeling, and holding operations for dietary supplements. Identity, purity, strength, and composition.
Preventive Controls — Human Food
FSMA preventive controls and updated CGMP for human food. Food safety plans, hazard analysis, supply-chain controls, sanitation, allergen and process controls.
Food CGMP (Legacy)
The original Good Manufacturing Practice regulation for human food, still referenced in many contractual and global supply agreements. Personnel, plant, equipment, and processes.
Pharmaceutical CGMP
Current Good Manufacturing Practice for finished pharmaceuticals. Organization, buildings, equipment, production controls, laboratory controls, records, and reports.
Medical Device QSR / QMSR
FDA’s Quality System Regulation for medical devices, harmonizing with ISO 13485 under the new QMSR. Design controls, CAPA, complaint handling, and traceability.
Quality Management Systems
The internationally-recognized QMS standard. Risk-based thinking, leadership commitment, process approach, customer focus, and continual improvement.
Medical Device QMS
Quality management system requirements specific to medical devices. Design controls, validation, risk management integration, and post-market surveillance.
Risk Management — Medical Devices
The application of risk management to medical devices throughout their full lifecycle. Risk analysis, evaluation, control, residual risk acceptability, and review.
METHODOLOGY
Four pillars of our audit practice.
Every JJCC Group engagement follows a disciplined sequence — analyze, plan, execute, remediate. Each phase produces concrete deliverables you and your leadership can act on.
PHASE 01 — DIAGNOSE
Gap Analysis
Every engagement begins by mapping your existing quality management system against the specific standard or regulation in scope. We review documented procedures, talk to process owners, and produce a clause-by-clause assessment of where you meet, partially meet, or fall short of requirements.
- Clause-by-clause QMS scoring against the target standard
- Documented vs. implemented comparison
- Prioritized, risk-ranked gap register
- Proposed structural and procedural changes
PHASE 02 — DESIGN
Audit Plan
A formal audit plan is built collaboratively before any auditor sets foot on the floor. Scope, criteria, departments, sampling strategy, document requests, interview schedule, and reporting format are agreed in writing so there are no surprises and no scope creep.
- Scope, criteria, and acceptance ground rules
- Department-by-department schedule
- Pre-audit document request list (delivered 7–10 days ahead)
- Stakeholder briefing and logistics coordination
PHASE 03 — EXECUTE
Audit Implementation
On-site or hybrid execution by lead auditors with regulated-industry depth. Opening meeting, evidence sampling, shop-floor observation, process tracing, interviews, daily debriefs, and a formal closing meeting with categorized findings — major, minor, observation.
- Opening and closing meetings with leadership
- Process tracing and evidence sampling
- Daily preliminary findings briefings
- Formal audit report with risk ratings and recommendations
PHASE 04 — REMEDIATE
Findings Closure
Findings on paper change nothing. JJCC Group helps you write root cause analyses, design corrective and preventive actions, rebuild or rewrite procedures, train teams, and verify effectiveness — staying engaged until every non-conformance is demonstrably closed.
- Root cause analysis facilitation
- CAPA design and implementation
- SOP authoring and document control improvements
- Effectiveness verification and follow-up audit
WHAT TO EXPECT
A two-to-five day engagement, scoped to your reality.
Audit length is driven by scope — facility size, number of product lines, number of standards in play, and depth of evidence sampling required. The framework below illustrates a representative five-day, multi-standard engagement. Shorter engagements compress these phases without sacrificing rigor.
Opening & Document Review
Opening meeting with leadership, scope confirmation, kickoff with the audit team, and review of quality manual, SOPs, policy documents, and organizational structure.
Production & Quality Floor
On-site observation of manufacturing, packaging, sanitation, and material handling. Process tracing from receipt through release. Interviews with operators and supervisors.
QA / QC, Lab & Records
Review of batch records, testing protocols, calibration logs, lab data integrity, environmental monitoring, and stability programs where applicable.
Support Systems & CAPA
Supplier qualification, training records, complaint handling, deviations, change control, internal audits, management review, and CAPA effectiveness.
Closing & Report
Findings consolidation, risk classification, draft closing presentation, formal closing meeting with leadership, and delivery of the comprehensive audit report with prioritized recommendations.
Areas & departments covered.
Final scope is established during planning. Below are the functional areas typically included in a comprehensive CFR or ISO audit. We adjust depth and sampling based on the regulation, your risk profile, and the engagement length agreed upon.
Core Operations
Core Operations
How to prepare your organization for the audit.
A well-prepared audit is a better audit — for everyone. The week before we arrive matters as much as the week we are on site. Here is what we ask clients to do, and what we help with.
STEP 01
Internal quality audit
Meets the internal audit requirement of your cGMP rule or ISO standard
STEP 02
Supplier and contract manufacturer audit
Qualifies or re-qualifies suppliers and CMOs
STEP 03
Gap analysis
Measures your system against a new regulation, such as the QMSR
STEP 04
ISO certification readiness
Prepares you for the Stage 1 and Stage 2 certification audits
STEP 05
Pre-acquisition due diligence
Assesses a target's compliance risk before you buy
STEP 06
FDA mock inspection
See our FDA Mock Audit page
SPECIALTY ENGAGEMENT
The FDA Mock Audit.
Regulations and standards we audit against
21 CFR Parts 111, 117, 210/211 and 820 (QMSR) · ISO 9001 · ISO 13485 · ISO 14971 · ISO 22716 · customer and retailer standards. We follow ISO 19011 audit practice.
A four-phase engagement
- Diagnose: scope, document request and risk-based audit plan.
- Diagnose: 2.2 to 5 days on-site or hybrid, covering every department in scope.
- Diagnose: findings graded by risk and cited to the regulation (by section) or standard (by clause).
- Diagnose: 4.fix plan, support, and a verification audit 60 to 120 days later.
- Linked remediation pathway — Every observation rolls into a CAPA plan with JJCC Group support, so the mock audit drives concrete change rather than a one-time scare.
An ISO accreditation preparedness plan that ends at certification.
JJCC Group’s ISO accreditation readiness program is structured to take your organization from where you are today to a successful stage-2 certification audit with your registrar. It starts with a gap analysis against the target standard, assesses the current quality management system, and proposes the changes — structural, procedural, and cultural — needed to close the distance.
STAGE 01
Gap Analysis
Clause-by-clause comparison of current QMS against ISO 9001, ISO 13485, or ISO 14971. Risk-ranked register of gaps with proposed remediation paths.
STAGE 02
QMS Build / Refine
Author or refine the quality manual, procedures, work instructions, and forms required to meet the standard. Document control infrastructure put in place.
STAGE 03
Internal Audit & Mgmt Review
Train internal auditors, conduct the first internal audit cycle, run the first formal management review — both are mandatory before certification.
STAGE 04
Mock Certification Audit
Full simulation of your registrar's stage-2 audit. Close any remaining findings. Walk into the real certification audit confident, not hopeful.
Most clients sequence this program over three to nine months depending on the maturity of their existing quality management system, the size of the organization, and the target certification date.
Findings are the starting line, not the finish.
Audit reports without remediation are expensive paperwork. JJCC Group stays engaged after the audit closes — addressing every non-conformance, restructuring weak processes, and verifying effectiveness — until your quality management system is demonstrably back in compliance with the regulation or standard in scope.
We work hands-on with your CAPA owners, document a clear remediation roadmap with milestones, and conduct follow-up verification audits to confirm closure. Our objective is not a clean report — it is a quality system that can withstand a real inspection on any given Tuesday.
What is included
- Root cause analysis facilitation — Workshops with process owners using 5-Why, fishbone, or fault-tree methods appropriate to the finding's severity.
- CAPA plan authorship — We help write defensible, evidence-tied CAPA records that hold up to second- and third-party scrutiny.
- SOP / procedure rewriting — Where procedures are the gap, we author or rewrite documents that are both compliant and operationally usable.
- Training program design — Where competency is the gap, we design training, assessments, and refresher cycles tied to the relevant SOP.
- Effectiveness verification audit — A follow-up audit (typically 60–120 days post-remediation) to confirm corrective actions held and findings are closed.
Testimonial
What our clients say about JJCC
Professional, knowledgeable team guided us through FDA registration and complete product listing accurately and efficiently.
Frequently asked questions
The questions we hear most often from QA leaders, plant managers, and executives evaluating an external audit engagement.
Areas we cover
Quality assurance and control · Production and packaging · Warehouse and distribution · Laboratory · Engineering and maintenance · Purchasing and suppliers · Training and HR records · Complaints, CAPA and management review
