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.
In this article I want to contrast conventional “quality management system audits” based on ISO 9001 and what I call “process-specific audits”.
1. Quality System Audits
The checklist is generic and is designed to be relevant to any process.
Advantages
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. (I wrote a list of the most common checkpoints before)
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:
- 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.
- It has the appearance of pure objectivity, since all checkpoints are somewhat derived from the ISO 9001 standard.
Drawbacks
- 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):
- 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
Advantages
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.
Drawbacks
- 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?
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PS: here is the list of processes we can audit (for reliability but also for efficiency):