Thermoforming SQE Audit Checklist: 47-Point Factory Evaluation

For Supplier Quality Engineers (SQEs), procurement quality, or quality directors auditing a thermoforming factory. This 47-point checklist is the framework DitaiPlastic uses internally for self-assessment, and what our largest automotive and medical customers use during their on-site audits.

Audit Scope: 7 Sections, 47 Checkpoints

Section 1: Quality Management System (8 points)
Section 2: Equipment & Process Capability (7 points)
Section 3: Material Management (6 points)
Section 4: Product Inspection & Testing (8 points)
Section 5: Production Control & Traceability (6 points)
Section 6: Tooling & Maintenance (6 points)
Section 7: People & Training (6 points)

Each checkpoint scores: Conformance / Minor NCR / Major NCR / Critical NCR.

Section 1: Quality Management System (QMS)

#	Checkpoint	Evidence Required
1.1	ISO 9001 certified, current	Cert + verification w/ registrar
1.2	Industry-specific cert (ISO 13485 / IATF 16949 / AS9100) if applicable	Cert
1.3	Documented quality manual, accessible to all employees	Manual review
1.4	Internal audit program with scheduled audits	Audit reports last 12 months
1.5	Management review of quality data quarterly	Meeting minutes
1.6	Customer complaint tracking with 8D process	Last 5 8D reports
1.7	Document control system (revisions tracked)	Document master list
1.8	Calibration program for measurement equipment	Calibration records

Section 2: Equipment & Process Capability

#	Checkpoint	Evidence Required
2.1	Equipment list with current calibration status	Equipment inventory + cal records
2.2	PM (preventive maintenance) program in place	PM schedule + records
2.3	Process parameters documented for each part	Run sheets / process control plans
2.4	SPC (Statistical Process Control) on critical dimensions	SPC charts last 90 days
2.5	Cpk capability data for FC dimensions	Capability study reports
2.6	Process change management with customer notification	Process change records
2.7	Equipment qualification for new tooling (FAI passed)	FAI reports

Section 3: Material Management

#	Checkpoint	Evidence Required
3.1	Approved supplier list (ASL) for sheet vendors	Vendor approval records
3.2	Material certificates retained for every lot	Cert sample audit
3.3	Incoming material inspection program	IQC records last 30 days
3.4	FIFO storage with environmental control	Warehouse walkthrough
3.5	Material lot traceability to finished part	Trace exercise from random part to lot cert
3.6	Material substitution control (no unauthorized changes)	Approval records

Section 4: Product Inspection & Testing

#	Checkpoint	Evidence Required
4.1	FAI process documented and trained	FAI procedure + recent FAI
4.2	In-process inspection at defined points	Inspection plan
4.3	Final inspection sampling per AQL	Inspection records
4.4	CMM available + calibrated for critical dimensions	CMM records
4.5	Visual inspection standards (light booth, cards)	Light booth walkthrough
4.6	Functional/destructive testing as specified	Test records
4.7	Non-conforming material control (segregation)	Reject area walkthrough
4.8	Inspection of customer-specific characteristics	Customer-specific inspection records

Section 5: Production Control & Traceability

#	Checkpoint	Evidence Required
5.1	ERP/MRP system tracking material to part	System demo
5.2	Lot/batch numbering on every produced part	Marking inspection
5.3	Production records retained per customer requirement	Records sample
5.4	Sequenced production for first-in-first-out delivery	FIFO walkthrough
5.5	Recall procedure for non-conforming product	Procedure + most recent recall
5.6	Capacity planning to prevent overload	Capacity board

Section 6: Tooling & Maintenance

#	Checkpoint	Evidence Required
6.1	Customer tools clearly identified, segregated	Tool storage walkthrough
6.2	Tool maintenance schedule + records	Tool log
6.3	Tool inspection on cycle count thresholds	Inspection records
6.4	Tool reconditioning procedure documented	Procedure
6.5	Backup/spare tools for high-volume programs	Spare tool inventory
6.6	Tool ownership documentation accurate	Customer tool ownership matrix

Section 7: People & Training

#	Checkpoint	Evidence Required
7.1	Skill matrix for production operators	Skill matrix doc
7.2	Operator training records, current	Training records sample
7.3	Quality inspectors trained and certified	Certification records
7.4	QC engineers experienced (>3 yrs typical)	Resume/CV review
7.5	Safety training (ISO 45001 or equivalent)	Safety records
7.6	Cross-training for redundancy on critical positions	Cross-training matrix

Audit Day Schedule (3-Day Format)

Day 1: Opening & Floor Tour (4-6 hours)

1. Opening meeting: agenda, objectives, opening team intros (30 min)
2. QMS overview presentation by quality director (30 min)
3. Factory walk-through, full process flow (90 min)
4. Open audit on Sections 1, 2 (Quality system, equipment) (3 hours)

Day 2: Materials, Production, Inspection (8 hours)

1. Section 3: Material management deep-dive (90 min)
2. Section 4: Inspection processes, witnessing in-process and final inspection (3 hours)
3. Section 5: Production control, traceability exercise (90 min)
4. Lunch w/ engineering team — informal capability check (60 min)
5. Wrap-up of day’s findings (30 min)

Day 3: Tooling, People, Closing (4-6 hours)

1. Section 6: Tooling and maintenance review (90 min)
2. Section 7: People and training (90 min)
3. Document review: open NCRs from past audits, completed CARs (90 min)
4. Closing meeting with NCRs presented, action plans agreed (90 min)

Findings & Reporting Format

For each finding, document:

• Checkpoint number and description
• Observation (what was found vs what was expected)
• Severity: Critical / Major / Minor
• Risk: which customer requirement is at risk?
• Required corrective action
• Target completion date
• Verification method

Severity Definitions

• Critical NCR: Likely to cause customer impact (recall, line-down). Examples: no incoming inspection, no FAI, no tool ownership records. Hold all shipments until resolved.
• Major NCR: Could cause customer impact. Examples: SPC missing, calibration out-of-date, training records incomplete. Resolve in 30-60 days.
• Minor NCR: Best-practice gap, not customer-impacting. Examples: documentation could be clearer, signage improvements needed. Resolve in 90 days.

Closing the Audit Loop

Document everything in a formal audit report including:

• Audit team and date
• Scope and standards referenced
• Summary of NCRs by severity and section
• Pictures of compliance and non-compliance examples
• Action plan with owners and dates
• Follow-up audit schedule (typically 6-12 months)

For DitaiPlastic, our last 8 customer audits resulted in:

• 0 Critical NCRs
• 1.3 Major NCRs average per audit (resolved in average 22 days)
• 3.7 Minor NCRs average per audit (resolved in average 51 days)

SQE Audit FAQ

How often should we audit our thermoforming supplier?

Initial qualification audit before tooling. Annual surveillance audit thereafter. For Tier-1 strategic suppliers, more frequent (every 6 months) with focused topics. For low-spend suppliers, every 2-3 years with desk-audit between visits.

How long does a typical audit take?

Standard 47-point audit: 3 days on-site for production-quality work. Quick certification check: 1 day. Detailed deep-dive on a specific concern (e.g., tolerance issues): 2 days. We host the full 3-day format for Tier-1 customers.

Can we use our own audit checklist instead of yours?

Absolutely. Most large customers come with their own checklists. We’ve completed audits using GM PPAP, Ford Q1, Toyota TPS, IATF 16949 detailed, IPC-A-610, and many customer-specific lists. We adapt to your checklist.

Do you allow customers to interview operators directly?

Yes — interview rooms available; QC inspectors and senior operators speak English; production engineering team available. Translation provided when needed. Standard practice for any audit.

What’s the cost of hosting your audit?

Customer pays travel/accommodation/per-diem. We provide on-site logistics, conference room, lunch, and full team time at no charge. Audit fee not invoiced.