Quality System Audits vs Process Specific Audits In this article, I want to contrast conventional quality system audits based on ISO 9001, and what I call process-specific audits. Why are each beneficial to importers, and what are the drawbacks you might find with them?

When it comes to estimating how reliable a potential supplier is, most importers choose to send a quality auditor. There are advantages to this approach, but experience has taught me that it is not always the best option.

1. Quality System Audits

The checklist is generic and is designed to be relevant to any process.


The auditor assesses whether the basics of a quality system are present:

  • Are inputs properly checked?
  • Is the process kept under control?
  • Are outputs properly verified/validated?
  • Are gauges and other checking instruments well-calibrated?
  • Etc.

Our checklist based on ISO 9001

We check the following points in detail when performing a quality system audit on your supplier or potential supplier.

  1. Supplier’s Understanding Of The Buyer’s Requirements
  2. Suppliers of Materials / Components
  3. Incoming Quality Control (IQC)
  4. Organization Of In-House Production
  5. In-Process Quality Control (IPQC)
  6. Subcontracted production
  7. Final Quality Control (FQC)
  8. Instruments & Machines
  9. Prevention Of Problems

Learn more about these 9 checkpoints in this blog post.

This is sufficient to spot poorly organized manufacturers. So there is a lot of value in asking these questions.

Why is this type of audit generally considered “the norm”? For two reasons:

  1. Hiring and training all-purpose quality auditors (who can check “any factory operations”) is a convenient thing to do. So that’s what all third party agencies push down their clients’ throats.
  2. It has the appearance of pure objectivity since all checkpoints are somewhat derived from the ISO 9001 standard.


  • Quality auditors usually have a superficial understanding of the production processes they examine. They mostly audit “around” and “between” the processes, which means a lot of issues can go unnoticed.
  • Savvy factories know how to script a visit and take advantage of a complacent auditor. This type of service can quickly morph into a document check in a meeting room, rather than an inquisitive tour of the factory.
  • Findings often lead to solutions that aim at increasing the size of the quality department: more controllers at every step of production, more engineers to prepare procedures… And that’s a problem. Chinese factory owners & managers are very focused on costs and they usually resist this type of recommendations.


2. Process-Specific Audits

This type of service requires an auditor with working experience on the process in question, working out of a checklist that lists the main risks to assess.

For example, when we audit an injection molding process, our engineers check the following aspects (in addition to the quality control steps seen above in section 1):

  • Technical Capability
  • Process Controls
  • Setup Procedures
  • Process Parameters
  • Cycling Parameters
  • Preventative Maintenance
  • Drying
  • Polymer Control
  • Polymer Delivery
  • Material Processing
  • Tool/Die Storage
  • Tool Design & Manufacturing Capabilities
  • Tooling Efficiency


It is useful in catching poorly organized factories (since it also includes checkpoints related to the quality system), but it also allows to catch:

  • Factories that don’t know what they are doing (e.g. jigs that allow operators to place a part in an incorrect position, a so-called engineer who doesn’t know the melting temperature of the most commonly used polymers…)
  • Factories that have habits detrimental to quality (e.g. using recycled material for plastic injection molding, taking shortcuts during the setup…)
  • Factories that don’t pay attention to the long-term stability and reliability of their processes (e.g. in-adapted maintenance programs, machines that are running at too high a speed…)

The auditor’s findings naturally lead to recommendations that aim at working smarter: adopting best practices that improve both productivity and quality. For example, adding a control jig that catches problems more quickly and more reliably than the current method. That’s something a Chinese factory owner will tend to say yes to.


  • The difficulty lies in finding ex-production engineers whose English level is sufficient to follow a checklist and report on their findings.
  • Since fewer auditors are available, travel costs are a bit higher than those of conventional quality audits.

What do you think? Any other limitations of these types of audits that you’ve encountered? Are you performing quality system audits to assess a supplier’s quality management or more focused process-specific audits?



Here is the list of processes we can audit (for reliability but also for efficiency) here at Sofeast:

  • General assembly & packing
  • Cut & sew for garments & bags
  • General metal machining
  • Die casting
  • Wood machining for furniture
  • Plastic injection molding
  • Rubber molding
  • Electronics

If any of these fit your production processes, take a look at our factory auditing solutions page to learn more about how we can help and get a no-strings quotation. 

Note: This blog post originally appeared in QualityInspection.org in 2014 here, but has been revised and edited for Sofeast readers.


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About Renaud Anjoran

Our founder and CEO, Renaud Anjoran, is a recognised expert in quality, reliability, and supply chain issues. He is also an ASQ-Certified ‘Quality Engineer’, ‘Reliability Engineer’, and ‘Quality Manager’, and a certified ISO 9001, 13485, and 14001 Lead Auditor.

His key experiences are in electronics, textiles, plastic injection, die casting, eyewear, furniture, oil & gas, and paint.

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