The Advanced Product Quality Planning Process

I have heard many people tell me “design and development is not linear, so it is hard to formalize”. That’s true, but there are ways to manage it as a process.

The ISO 9001 standard pushes companies to plan for their design and development work, but it doesn’t go very much in depth. Fortunately, the large car manufacturers have formalized a detailed set of process steps they expect their suppliers to follow. They call it “Advanced” Product Quality Planning.

Its objective is to maximize the probability that the new product will fulfill the customer’s requirements.

Its steps can be outlined as below:

1. Planning

1.1 Inputs: customer suggestions/requirements, historical information about similar products, the company’s objectives…

1.2 Output: a detailed plan that includes goals for design and for quality/reliability, preliminary process information, and preliminary product features.

2. Product design & development

2.1 Input: step 1.2.

2.2 Outputs: design FMEA, DFM analysis, drawings and first prototypes, material specifications, reviews and verifications, requirements for testing equipment….

3. Process design & development

3.1 Input: step 2.2.

3.2 Outputs: process flow chart, process FMEA, process instructions, quality system review and preliminary control plan…

4. Product & process validation

4.1 Input: step 3.2.

4.2 Outputs: a pilot production run that went through the process steps outlined above and went through testing & inspection, and detailed evaluation of the results.

5. Feedback, assessment, and corrective actions

5.1 Input: step 4.2.

5.2 Outputs: application of what was learned in step 4 to get closer to the goals of step 1. The objective is to be ready for production launch.

The Advanced Product Quality Planning process is one of the “core tools” required by the ISO/TS 16949 standard. Thousands of companies follow it. It works. Our consultants have used it successfully to help a few US companies with production launch of new products.

I believe most importers who develop custom-made products could get a lot of benefit from this structured approach. Naturally it requires to work closely with the manufacturer and to understand their processes, and that can be difficult. But following this discipline only increases the chances of success.

What do you think?

Are ISO 9001 Certified Suppliers the Best in China?

Here areBest Quality & Sourcing Articles some interesting or useful articles that I found recently.

Quality Management Systems in China Explained

Fredrik Grönkvist asked me the following questions about certifications to the ISO 9001 standard (and to other QMS standards):

  • What is a Quality Management System and why is it relevant to importers?
  • Is certification mandatory, or is it common that Chinese manufacturers implement a Quality Management System without obtaining the paper?
  • How can you determine if the supplier is applying a comprehensive Quality Management System if they are not certified?
  • How common is it that suppliers do obtain a QMS certificate without actually implementing it?
  • Is QMS certification more important in some industries, and less important in others?
  • What other signals do you recommend small to medium volume importers look at?

7 reasons why it is hard to start small when buying from China [Infographic]

Purchasing small quantities in China is not easy. Learn why in this infographic based on an article written by Adam Gilbourne. Very true.

China Wages Policy Backfires as Costs Prompt Sock-City Blues 

The town of Zhuji is a cluster of sock manufacturers. Most of the work is done by machines, and yet factory owners complain of the rising cost of labor. They don’t understand that they need to change their “one worker tends to one machine” mentality, as well as their way of doing business.

How Do Small Textile Factories Survive in Expensive China?

Neale O’Connor, an Australian professor and researcher who studies the Chinese manufacturing sector, visited a few textile factories and took notes about the managers’ grievances.

China Manufacturing: How To Hang On To YOUR Molds

Surprisingly, I still see many purchasers use agreements that can’t be enforced in China, and many others who blindly trust their suppliers. These are big mistakes. In this article, Dan Harris reminds us of legal strategies to discourage Chinese suppliers from appropriating the tooling paid for by importers.

The Decline of the Buying Office

This article describes the changing role of the trading companies and the in-house buying offices, when it comes to serving large textile importers. The latest trends include the increase in functions of the buying office, and the higher risk of making tax-free profit in Hong Kong.

Patent Fiction 

China’s patent applications are nearly double those of the US or Japan. Does it mean that Chinese companies are developing a lot of new technologies and new products? Not exactly, as The Economist demonstrates.

Writing Down Measurement Findings During an Inspection

When it comes to checking garments, or precision mechanical pieces, inspectors can spend most of their time checking measurements. And, in many cases, they need to write down their findings one by one.

There are few common pitfalls to look out for:

  • Use of measurement instruments that are not calibrated (poor accuracy) or that lack precision
  • Inadvertent human errors (misreading the instrument, or miswriting the finding)
  • Rounding: the inspector doesn’t write the exact finding (loss of accuracy)
  • Flinching: the inspector finds a sample slightly outside a tolerance limit, yet inputs it as just inside the limit
  • Cheating: the inspector doesn’t check as many pieces as he/she should, and makes up the numbers that are reported

So many things can be wrong, it makes sense to question that process, as a reader who wrote this to me a few days ago:

I wanted to know what your thoughts are on recording actual measurements for dimensional inspection. We currently are required to record actuals but once the product goes one way and the records go another… there is literally no tracibility to the product.

Why must a actual be recorded if acceptable to drawing specification? We do record actuals if out of tolerance on a nonconformance report… which I agree with.

We do record actuals for first article and internally produced parts.. and parts with serial numbers… which I agree as well.

This is a very valid question. I think writing down the actuals only makes sense in the following cases:

  • In case the product has a unique ID number, like a MAC ADDRESS for example, there is traceability. An alternative (especially for garments) is to have the inspector paste a small sticker in a place that is not very visible (for example on the care/composition label).
  • If there is very little trust in the inspectors. Some records, even without traceability to the samples that were measured, are better than not records at all.
  • Whether a finding is on target, or close to a tolerance limit, is not really the same. Some capability indexes, such as Cpm, take it into account. A company that runs this type of analyses needs to know exactly what values were found. Not to mention measurement system analyses such as gage R&R.

Unfortunately, as a service provider, most of our clients request us to write down the exact findings. It is time consuming, but sometimes we can devise a few tricks to go faster while losing only a bit of precision. Here are couple of examples:

  • For certain outer measurements of mechanical pieces, a gauge that makes it obvious when a piece is outside tolerance can be designed and made inexpensively.
  • For certain measurement points of garments (for example the waistband), it is possible to pile up 10 pieces and check if they are all roughly the same length.

At the end of the day, the question is: how much time can be saved by not writing all the details? And would that time be more wisely spent on other tasks?

Advantages and Drawbacks of the ISO/TS 16949 Standard

One of our regular readers, Brad Pritts, sent me a note about yesterday’s article. I thought it was a great follow up. Here it is.

I’ve been working with ISO TS 16949 since its inception, and with its predecessor, QS-9000. I’d have a few comments for those unfamiliar with it.

1) Why did it come about?

As mentioned, the auto industry is highly dependent on supplier quality; they’ve had their own approaches for SQA since the late 1970’s. Besides the difficulty of change, think about the complexity due to the numbers of parts involved in a car. Typical assembly plant gets deliveries of 2,000 – 4,000 part numbers to build the cars. This number counts complex assemblies such as engine, transmission, and axle as 1 part each, so the total number of components is 10,000 to 20,000. If any one is defective the whole car is defective to some extent (an oversimplification, but not by much.) If each supplier has a failure rate of 1 part per thousand, then the typical car will have 10 – 20 defects. So we aim for perfection, with actual performance (ideally) in the parts per million defective range.

2) How is it better than ISO 9001?

A. Many auto industry specific additions, as Renaud listed in the article; mostly good practices. The “Core Tools” in particular provide very specific and prescriptive methods for quality planning.

B. A strict administrative/accreditation process that weeds out poor quality auditors and shady registrars. (Unfortunately it also discourages some good auditors, but that’s another story!)

But there are also some disadvantages/ problems, such as:

C. A vaguely defined, clumsy (in my opinion) method of implementing the “process approach”. I have no dispute that the ISO 9001 standard requires the adoption of a process approach but the TS oversight people have cobbled up what I consider a poor approach for process management. Furthermore, they have never codified it, so the only
way to learn it is from the auditors.

D. A few requirements which are impractical for some suppliers but are nonetheless mandatory, with little room for auditor judgement to consider them as not applicable. One, for example, is the requirement for “predictive” maintenance techniques. These are great for some industries (e.g. vibration studies for large complex machinery) but not really helpful for other simpler processes such as stamping.

E. An insistence on prioritizing audit time to the specific products made for the TS sponsoring companies (GM, Ford, Chrysler, Renault, VW, etc,. but NOT Honda, Toyota, etc.) This results in odd audit schedules and practices for companies who have limited business with the sponsoring companies; the same GM or VW job may get audited again and again while the Honda job never does. Quite contrary to the normal spirit of random auditing.

I tell quality professionals from other industries that they should study the auto industry and TS 16949 as a role model. Many of its provisions are great; and even the ones that are lousy can always serve as bad examples!

ISO/TS 16949: Great Improvements Over ISO 9001

Over the past few days I have been learning a lot about the ISO/TS 16949 standard. We are working on the development of adequate auditing services to clients in the automotive industry.

This “technical specification” (TS) goes much further than ISO 9001, and is closer to quality management best practices.

What is this TS about and where does it originate?

As mentioned in a previous article, a car maker (e.g. GM, VW…) can’t switch a supplier once a car model is in production. So they have to ensure they work with well-organized manufacturers. They have no second chance!

The TS is a set of minimum requirements for car component manufacturers. It was originally developed by “Big Three” in the US, and then European car brands joined this scheme. Even a few Chinese car brands recognize it and use it.

It has to be relevant and applicable to a very wide product range, from the textile or leather of the seats, to wood parts used in luxury cars, to lighting and electronic systems, to the rubber of tires, etc. So overall it is rather generic — but less so than ISO 9001, which also applies to service providers.

What elements from the TS are particularly interesting?

I noted a few requirements that are absent from ISO 9001 but that, I think, are

  • The factory layout should be designed to make material flow easy. The premises must be in a state of order and cleanliness. There is a mention of the need to focus on lean manufacturing principles, and the term “continual improvement” replaced ISO 9001’s “continuous improvement”.
  • The factory must have contingency plans in case of emergency (power shortage, key equipment failure…), to reduce the likelihood of shipment delays.
  • The factory must review quickly (in less than 2 working weeks) the engineering specifications received from customers.
  • Many more elements must be considered during the design and development process — for example, failures noticed on vehicles on the road, the impact on worker safety in the factory, etc. The use of FMEA (an excellent but rather difficult preventive action tool) is mandatory.
  • The factory must provide on the job training to all staff for new/modified jobs that have an impact on product quality.
  • Work instructions must be written down for all operations that have an impact on product quality.
  • Someone must have authority to stop production if quality issues appear — even during the night shift.
  • Acceptance sampling based on AQL limits is not allowed. A whole batch must be rejected when 1 defect is found, then the supplier has to check the entire batch piece by piece, and a corrective action plan needs to be implemented.
  • The factory must apply the “core tools” of the auto industry — for example the quality plan needs to go much more in depth than what an ISO 9001 auditor could accept, and new product developments need to follow a much stricter process.

Is it as easy to game as ISO 9001?

Probably not. It is managed by an industry body which authorizes much fewer certifying bodies than are authorized for ISO 9001. It reduces the likelihood of auditors and audit program managers following substandard practices, as is oftne the case during third-party ISO 9001 certifying audits.

What do you think? Any experience with this standard?