Vendor Audit Questionnaire for Laminated Tube (Lamitube) Manufacturer

🔷 1. Quality Management System (QMS)

Main Question:

How is the Quality Management System established, implemented, and maintained?

Breakdown:

Is there a documented Quality Manual aligned with GMP?
Are SOPs controlled, approved, and version-managed?
How is document lifecycle (issuance → archival) controlled?
Are quality objectives defined and periodically reviewed?
Is there a system for Quality Risk Management (ICH Q9 aligned)?
Are deviations, CAPA, and change control systems integrated?
Is management review conducted periodically?

🔷 2. Regulatory Compliance & Certifications

Main Question:

Does the company comply with applicable regulatory and GMP requirements?

Breakdown:

Which certifications are held (ISO 9001, ISO 15378, GMP)?
Are audits conducted by regulatory agencies or customers?
Are previous audit findings available with CAPA status?
Is there compliance with pharma packaging guidelines?
Are regulatory inspections documented and closed?

🔷 3. Personnel & Training

Main Question:

Are personnel qualified, trained, and compliant with GMP?

Breakdown:

Is there an organizational chart with defined responsibilities?
Are job descriptions documented?
How is initial and ongoing GMP training conducted?
Are training effectiveness evaluations performed?
Are personnel hygiene and gowning procedures defined?
Are operators trained in contamination control?

🔷 4. Premises & Facility Design

Main Question:

Is the facility designed to prevent contamination and mix-ups?

Breakdown:

Is material and personnel flow logically segregated?
Are clean/controlled areas defined (if applicable)?
Is there HVAC system qualification and monitoring?
Are pest control systems in place?
Are lighting, temperature, humidity controlled?
Are utilities (compressed air, water) monitored?

🔷 5. Equipment & Maintenance

Main Question:

Are equipment qualified, calibrated, and maintained?

Breakdown:

Is there a list of critical equipment?
Are IQ/OQ/PQ performed where applicable?
Is preventive maintenance planned and documented?
Are calibration records maintained?
Are breakdowns recorded and investigated?
Is cleaning of equipment validated or verified?

🔷 6. Raw Materials Control

Main Question:

How are raw materials (e.g., laminate, resins, inks) controlled?

Breakdown:

Are suppliers qualified and approved?
Are incoming materials tested against specifications?
Is there a quarantine → release system?
Are COAs verified?
Are storage conditions controlled?
Is FEFO/FIFO followed?

🔷 7. Production & Process Control

Main Question:

Are manufacturing processes controlled and validated?

Breakdown:

Are batch manufacturing records (BMR) available?
Are critical process parameters defined and monitored?
Is process validation performed?
Are line clearance procedures implemented?
Are in-process checks documented?
Is rejection/rework controlled?

🔷 8. Printing & Artwork Control (Critical for Lamitube)

Main Question:

How is printed artwork controlled to prevent errors?

Breakdown:

Is artwork approved by customers before printing?
Are master artworks securely controlled?
Are printing plates/cylinders controlled and verified?
Is line clearance done between different artworks?
Are barcode and text verification systems used?
Are reconciliation procedures in place?

🔷 9. Cleaning & Contamination Control

Main Question:

Are cleaning procedures effective to prevent contamination?

Breakdown:

Are cleaning SOPs defined for all areas?
Are cleaning records maintained?
Is cleaning validation required and performed?
Are residues (ink, adhesive) controlled?
Are cross-contamination risks assessed?

🔷 10. Laboratory Controls & Testing

Main Question:

Are QC laboratory operations reliable and compliant?

Breakdown:

Are specifications defined for tubes (dimension, leakage, print quality)?
Are test methods validated?
Is there an approved sampling plan?
Are instruments calibrated?
Are OOS (Out of Specification) handled properly?
Are retain samples stored?

🔷 11. Packaging & Finished Product Control

Main Question:

How are finished laminated tubes controlled and released?

Breakdown:

Are finished goods inspected before release?
Is batch traceability ensured?
Are packing materials controlled?
Are labeling and identification clear?
Is transport validation considered?

🔷 12. Storage & Distribution

Main Question:

Are storage and distribution conditions controlled?

Breakdown:

Are warehouses clean and organized?
Are environmental conditions monitored?
Are dispatch procedures documented?
Is traceability maintained during shipment?
Are damaged goods handled properly?

🔷 13. Deviations, CAPA & Change Control

Main Question:

Are quality issues effectively managed?

Breakdown:

Are deviations recorded and investigated?
Is root cause analysis performed?
Are CAPAs tracked for effectiveness?
Are changes evaluated for impact before implementation?
Is change control linked to validation?

🔷 14. Complaint Handling & Recall

Main Question:

Is there an effective system for complaints and recalls?

Breakdown:

Are customer complaints logged and investigated?
Is trending analysis performed?
Is there a mock recall system?
How quickly can products be traced and recalled?
Are regulatory authorities notified if required?

🔷 15. Data Integrity & Documentation

Main Question:

Is data integrity ensured across all systems?

Breakdown:

Are records attributable, legible, contemporaneous (ALCOA)?
Are electronic systems validated?
Are audit trails enabled?
Is access control implemented?
Are backups performed regularly?

🔷 16. Vendor & Supply Chain Control

Main Question:

How are upstream vendors controlled?

Breakdown:

Is there an approved vendor list (AVL)?
Are vendor audits conducted?
Are critical suppliers periodically re-evaluated?
Are agreements (Quality Agreements) in place?

🔷 17. EHS (Environment, Health & Safety)

Main Question:

Are safety and environmental controls implemented?

Breakdown:

Are MSDS available for chemicals (inks, solvents)?
Are hazardous materials stored properly?
Is waste disposal compliant?
Are fire safety systems installed?
Are emergency procedures defined?

🔷 18. Continuous Improvement

Main Question:

Does the company focus on continuous improvement?

Breakdown:

Are KPIs defined (rejection rate, complaints)?
Are internal audits conducted?
Are improvement projects documented?
Is trend analysis performed?

✅ Pro Tips for Strong Vendor Audit (Practical Execution)

Focus heavily on:
- Artwork control (highest risk in tubes)
- Traceability (batch → raw material → dispatch)
- Line clearance & mix-up prevention
Ask for live records, not just SOPs.
Perform shop-floor verification (not just QA office review).
Cross-check:
- BMR vs actual production
- COA vs test raw data
Look for data integrity red flags (backdating, overwriting, missing logs)

🔴 SERIES–2: ADVANCED / FORENSIC VENDOR AUDIT QUESTIONS

🔷 1. QMS Effectiveness (Beyond Documentation)

Main Question:

How do you demonstrate that your QMS is effective, not just compliant?

Breakdown:

Show last 12 months trend of deviations vs CAPA closure time
What % of CAPAs are delayed? Justify
Provide example where CAPA failed → what was done next?
How do you ensure recurrence does NOT happen?
Are KPIs linked to management incentives?
Show evidence of risk-based decision making, not SOP-driven only

🔷 2. Data Integrity (Critical – High Risk Area)

Main Question:

How do you ensure ALCOA+ compliance in real operations?

Breakdown:

Show raw data vs reported COA → any mismatch?
Are there any blank spaces, overwriting, backdating in records?
Who reviews audit trails and how frequently?
Can operators delete or modify data?
Show one real audit trail for a batch
What controls prevent “testing into compliance”?
How do you detect unofficial records (shadow documentation)?

🔷 3. Deviation Investigation Depth

Main Question:

How robust is your root cause investigation?

Breakdown:

Show a major deviation report (last 6 months)
Was root cause scientifically justified or assumed?
Was 5 Why / Fishbone / FMEA used?
Were multiple root causes considered?
Was QA independent in conclusion approval?
How do you verify root cause correctness?

🔷 4. Change Control – Hidden Risks

Main Question:

How do you ensure changes do not introduce unseen risks?

Breakdown:

Show a recent change control affecting production
Was risk assessment formal (ICH Q9)?
Were validation/revalidation requirements evaluated?
Was customer notified (for critical changes)?
Were changes implemented before approval (backdoor change)?
How do you track temporary changes?

🔷 5. Process Validation – Real Assurance

Main Question:

How do you prove your process is consistently capable?

Breakdown:

Show Process Validation Report
Are worst-case conditions included?
What is the process capability (Cp/Cpk)?
How are critical parameters justified?
Is continued process verification (CPV) performed?
Show trend of in-process rejection over time

🔷 6. Artwork & Printing – Zero Error Expectation Area

Main Question:

How do you ensure zero artwork error, considering high regulatory risk?

Breakdown:

Show real case of artwork error → what happened?
Is there 100% vision inspection or manual?
How is mix-up between similar artworks prevented?
Are cylinders uniquely coded and verified?
Is there dual verification before printing?
What is reconciliation tolerance for printed tubes?

🔷 7. Line Clearance – Practical Effectiveness

Main Question:

How do you guarantee zero mix-up between batches/products?

Breakdown:

Demonstrate a live line clearance
Who verifies clearance (production vs QA)?
Are previous batch remnants physically checked?
Are labels/artwork fragments controlled?
Is photographic evidence used?

🔷 8. Supplier Risk Management

Main Question:

How do you control risks from your raw material suppliers?

Breakdown:

Show supplier risk categorization
How often are critical suppliers audited?
Any supplier disqualified recently? Why?
How do you verify supplier COA reliability?
Do you perform skip testing or full testing?

🔷 9. Laboratory Control – Reliability Check

Main Question:

How do you ensure QC results are scientifically reliable?

Breakdown:

Show OOS investigation (real case)
Was Phase I / Phase II investigation followed?
Are analysts trained on data integrity?
Any retesting without justification?
How are reference standards controlled?

🔷 10. Rejection, Rework & Scrap Control

Main Question:

How do you prevent rejected materials from re-entering the system?

Breakdown:

Show rejected batch records
Is rework scientifically justified and approved?
How is scrap physically destroyed?
Any case of unauthorized reprocessing?
Are rejection trends analyzed?

🔷 11. Traceability (Backward & Forward)

Main Question:

Can you trace any product within minutes?

Breakdown:

Perform mock traceability test:
- Finished tube → raw material batch
- Raw material → all affected customers
Time required to retrieve data?
Is system manual or ERP-based?
Any gaps in traceability observed?

🔷 12. Complaint Handling – True Root Cause

Main Question:

How do you ensure complaints lead to real improvement?

Breakdown:

Show last 5 complaints
Are trends analyzed (e.g., print defect, leakage)?
Were CAPAs effective?
Any repeated complaints for same issue?
Was customer feedback incorporated?

🔷 13. Recall System – Practical Readiness

Main Question:

How prepared are you for a real recall?

Breakdown:

Show last mock recall report
Time taken to complete recall simulation?
% traceability achieved?
Are customers informed in simulation?
Are regulatory requirements considered?

🔷 14. Cleaning Validation (Critical for Cross-Contamination)

Main Question:

How do you ensure no carryover of ink/chemical residues?

Breakdown:

Are worst-case products selected?
What is acceptance criteria (scientific or arbitrary)?
Are swab/recovery studies performed?
Is visual cleanliness justified scientifically?
Any failure observed in cleaning validation?

🔷 15. Environmental Control (Especially Printing Area)

Main Question:

How do environmental factors impact product quality?

Breakdown:

Are temp/humidity linked to print quality?
Any environmental excursions recorded?
Impact assessment done?
Are sensors calibrated?

🔷 16. Warehouse – Hidden GMP Gaps

Main Question:

How do you prevent mix-up and deterioration in storage?

Breakdown:

Are status labels (Quarantine/Released/Rejected) clear?
Any case of wrong material issuance?
Are returns segregated?
Is pest control effective (show logs)?

🔷 17. Internal Audit Effectiveness

Main Question:

Are internal audits truly identifying gaps?

Breakdown:

Show last internal audit report
Were critical findings raised?
Any repeat observations?
Is QA independent from production?

🔷 18. Management Commitment (Reality Check)

Main Question:

How does top management ensure GMP compliance?

Breakdown:

Are resources sufficient (manpower, budget)?
Any production vs quality conflict?
Example where batch was rejected despite pressure
Are quality metrics reviewed at top level?

🔥 HIGH-IMPACT AUDIT TECHNIQUES (Use During Audit)

Ask: “Show me now” instead of “Do you have”
Cross-question same topic with:
- Operator
- Supervisor
- QA
Pick random batch → trace everything
Compare:
- SOP vs actual practice
Watch for:
- Delayed entries
- Too-perfect records
- Identical handwriting

🔴 SERIES–3: TRAP QUESTIONS (HIGH-IMPACT AUDIT TOOL)

⚠️ How to use:

Ask indirectly
Cross-check answers between departments
Always demand live evidence

🔷 1. “Show Me Now” Trap (Reality vs Documentation)

Main Trap Question:

“Can you show me a batch currently under processing and all associated live records?”

Trap Breakdown:

Does the operator hesitate or call QA first?
Are entries made in real-time or backfilled?
Do timestamps align with actual process time?
Is handwriting consistent or pre-filled?

👉 Red Flag: Records updated just before showing

🔷 2. Data Integrity Trap (Backdating Detection)

Main Trap Question:

“Pick any record from last week—can you explain when exactly this entry was made?”

Trap Breakdown:

Compare:
- Ink color / pen variation
- Time gaps between entries
Ask operator:
- “Did you write this immediately or later?”

👉 Red Flag: Same pen, same handwriting for full shift data

🔷 3. Shadow Documentation Trap

Main Trap Question:

“Do operators ever use rough sheets before final entry?”

Trap Breakdown:

Check drawers, behind machines
Ask casually: “How do you remember readings before writing?”

👉 Red Flag: Unofficial notebooks / loose papers

🔷 4. Deviation Suppression Trap

Main Trap Question:

“In the last 3 months, did any process fail but was not recorded as deviation?”

Trap Breakdown:

Cross-check:
- Maintenance logs
- QC OOS
- Production downtime
Compare with deviation register

👉 Red Flag: Events exist but no deviation raised

🔷 5. CAPA Effectiveness Trap

Main Trap Question:

“Show a deviation that happened twice—why did CAPA fail first time?”

Trap Breakdown:

Check recurrence
Evaluate depth of root cause

👉 Red Flag: Same issue repeating with different wording

🔷 6. Artwork Mix-up Trap (Critical for Tubes)

Main Trap Question:

“What prevents two similar artworks from being mixed during printing?”

Trap Breakdown:

Physically verify:
- Cylinders
- Printed tubes
Ask operator to explain difference

👉 Red Flag: Reliance only on visual check without system control

🔷 7. Line Clearance Trap (False Compliance)

Main Trap Question:

“Can we check the previous product run on this line?”

Trap Breakdown:

Look for:
- Leftover labels
- Tubes under machine
Ask: “Who verified clearance?”

👉 Red Flag: Clearance signed but physical evidence remains

🔷 8. Training Effectiveness Trap

Main Trap Question:

Ask operator directly:
“Explain what you will do if you find a defective tube?”

Trap Breakdown:

Compare with SOP
Check confidence level

👉 Red Flag: SOP exists but operator unaware

🔷 9. QC Testing Manipulation Trap

Main Trap Question:

“Have you ever repeated a test because the first result was not acceptable?”

Trap Breakdown:

Ask follow-up:
- “Was it documented?”
Check raw data vs final COA

👉 Red Flag: Retesting without investigation

🔷 10. OOS Handling Trap

Main Trap Question:

“Show me an OOS result and explain full investigation”

Trap Breakdown:

Check:
- Hypothesis-driven investigation
- Lab error justification

👉 Red Flag: Blaming analyst without proof

🔷 11. Change Control Bypass Trap

Main Trap Question:

“Have you ever implemented a change urgently before approval?”

Trap Breakdown:

Cross-check with production/engineering
Verify temporary changes

👉 Red Flag: Verbal approvals / undocumented changes

🔷 12. Supplier COA Trust Trap

Main Trap Question:

“Do you always test raw materials or rely on supplier COA?”

Trap Breakdown:

Ask:
- “When was last full testing done?”

👉 Red Flag: Blind trust in supplier without verification

🔷 13. Traceability Stress Test (Live Challenge)

Main Trap Question:

“Trace this finished tube to raw materials within 10 minutes”

Trap Breakdown:

Observe:
- Time taken
- Data gaps

👉 Red Flag: Delays, incomplete traceability

🔷 14. Scrap Control Trap

Main Trap Question:

“What happens to rejected printed tubes?”

Trap Breakdown:

Physically inspect scrap area
Check destruction records

👉 Red Flag: Scrap accessible / reusable

🔷 15. Warehouse Mix-up Trap

Main Trap Question:

“Can you show any wrongly placed material found in last audit?”

Trap Breakdown:

Check labeling system
Verify segregation

👉 Red Flag: Same-looking materials stored together

🔷 16. Environmental Excursion Trap

Main Trap Question:

“What happens if humidity exceeds limit during printing?”

Trap Breakdown:

Ask for real case
Check deviation link

👉 Red Flag: No impact assessment

🔷 17. Internal Audit Integrity Trap

Main Trap Question:

“Why were no critical observations found in last internal audit?”

Trap Breakdown:

Compare with your findings

👉 Red Flag: Internal audit too “clean”

🔷 18. Management Pressure Trap

Main Trap Question:

“Has production ever continued despite quality concern?”

Trap Breakdown:

Ask different levels separately

👉 Red Flag: Conflicting answers

🔷 19. “Too Perfect System” Trap

Main Trap Question:

“You have zero deviations last month—how is that possible?”

👉 Red Flag: Indicates underreporting

🔷 20. Contradiction Trap (Powerful Technique)

Method:

Ask same question to:

Operator
QA
Supervisor

👉 Compare answers

Example:

“Who performs line clearance?”
“Who approves deviation?”

👉 Red Flag: Different answers

🔥 CRITICAL OBSERVATION SKILLS (MOST IMPORTANT)

During audit, continuously watch for:

⛔ Entries written in same handwriting
⛔ No corrections in months (unrealistic)
⛔ Fearful operators
⛔ QA answering everything (production silent)
⛔ Delayed data retrieval
⛔ “We always follow SOP” without explanation

🧠 PRO AUDITOR STRATEGY (FIELD-LEVEL)

Never rely on verbal answers
Always:
- See → Verify → Cross-check
Use silence pressure (wait after asking)
Randomly select:
- Batch
- Operator
- Record

✅ If you want FINAL LEVEL (ELITE)

I can prepare:

🔷 “Audit Scoring System”

Critical / Major / Minor classification
Risk-based scoring (FDA-style)

🔷 “Lamitube-Specific Risk Matrix”

Leakage risk
Print toxicity risk
Extractables/leachables concern

🔷 “DGDA Bangladesh Audit Angle”

Local regulatory expectations
Common inspection findings in Bangladesh