A factory audit is the point where claims made in a sales deck get tested against physical reality. For buyers committing to a long-term supply relationship — particularly for a regulated product like condoms — an audit is one of the most valuable steps in supplier due diligence, whether conducted in person or via a documented remote review.
This article outlines the areas an audit should typically cover and the kinds of questions that reveal whether a facility's quality claims are substantiated by its actual operations.
Preparing for the Audit
Before the visit, buyers should request in advance:
- Copies of current certifications (ISO 4074, EN ISO 13485, and any local licenses)
- An organizational chart showing who owns quality decisions
- Recent internal or third-party audit reports, if the manufacturer is willing to share them
- A general facility layout to understand production flow
Areas to Inspect On-Site
Raw Material Handling and Traceability
Ask how incoming natural rubber latex is inspected, tested, and tracked. A well-run facility should be able to trace a finished lot back to specific raw material batches, and should have documented criteria for accepting or rejecting incoming material.
Production Flow and Process Control
Walk the production line from latex compounding through dipping, vulcanising, stripping, and electronic testing to final packaging. Ask how process parameters (temperature, dipping speed, cure time) are monitored and what happens when a parameter drifts outside its defined range.
In-Process and Lot Release Testing
Confirm which tests are performed in-house versus outsourced, and observe the testing lab if possible. Ask to see how lot sampling records are documented and how accept/reject decisions are recorded and retained.
Calibration and Equipment Maintenance
Testing equipment (air burst testers, electronic pinhole testers, tensile testers) is only as reliable as its calibration schedule. Ask for calibration records and how frequently equipment is serviced.
Environmental and Storage Conditions
Since natural rubber latex is sensitive to heat, light, and ozone, ask how raw material and finished goods are stored, and whether storage areas are climate-controlled or monitored.
Personnel Training and Hygiene
Ask how operators are trained on quality procedures, how training is documented, and what hygiene and gowning protocols apply in production areas.
A Sample Audit Question Set
| Area | Sample question |
|---|---|
| Certifications | Which certification body issued your ISO 4074 and EN ISO 13485 certificates, and when were they last renewed? |
| Traceability | Can you trace this finished carton back to the specific latex batch used? |
| Testing | What percentage of production goes through electronic pinhole testing versus destructive sample testing? |
| Non-conformance | Walk me through your last lot rejection — what happened and what corrective action was taken? |
| Capacity | What is your current utilization against installed capacity, and how would a new order fit your production schedule? |
| Documentation | Can I see a redacted example of a certificate of analysis for a past shipment? |
What Good Answers Look Like
A well-run facility will generally answer these questions with specifics — document references, named procedures, and a willingness to show records — rather than general reassurances. Hesitation to produce documentation on request, or an inability to describe how a non-conforming lot was handled, are both worth following up on.
After the Audit
Buyers should document findings against a standard checklist so results can be compared across multiple candidate manufacturers, and should follow up on any open items (missing documentation, unclear answers) before finalizing a supply agreement.
Safeguard Contraceptives and Audit Readiness
Safeguard Contraceptives operates a single-site facility in Aurangabad (Chhatrapati Sambhajinagar), Maharashtra, India, certified to ISO 4074:2015 and EN ISO 13485:2016, with more than 40 years of manufacturing history behind its own brands SKINN and TOUCH ME as well as its contract manufacturing work. The company welcomes buyer audits as a standard part of supplier qualification.
Key Takeaways
- A factory audit should verify certifications, raw material traceability, production process control, testing practices, and equipment calibration.
- Ask for documentation, not just verbal confirmation, on every claim.
- How a facility handles a lot rejection or non-conformance is often more revealing than its pass-rate claims.
- Use a standard question set to keep audits comparable across multiple manufacturers.
If you would like to arrange an audit or request documentation ahead of one, contact Safeguard Contraceptives with your requirements.