Product Identification and Traceability
Inspection, Testing, Calibration, and Control
Control of nonconforming product
Storage, Packaging, Handling and Delivery
Major problem areas (primary sources of ISO 9000 nonconformances)
Statistical hypothesis testing
Manufacturing worker's role in quality
Concept of variation in quality and SPC
excerpt from SPC Essentials
and Productivity Improvement: A Manufacturing Approach
The book includes a section on the ISO 9000 standard for quality systems. It describes ISO 9000 and some of its provisions, and explains why it is important. The goal is to promote awareness of ISO 9000 at all organizational levels, especially among frontline workers. The people who do the job every day are often in the best position to notice things that do not conform to ISO 9000. If your company is seeking or maintaining ISO 9000 registration, this section should answer your production workers' questions about the program.
ISO 9000Anything that can go wrong, will.
ISO 9000 is a system for making sure that everything will go right.
ISO 9000 is a set of international standards for quality management systems. It applies to management and process controls for assuring quality. Companies that meet these standards can receive ISO 9000 registration from accredited registrars. Many industrial customers are starting to require their suppliers to achieve ISO 9000 certification. The standards include ISO 9002, which is for production, installation, and servicing. ISO 9001 includes all the elements of ISO 9001, and adds standards for product design.
The automotive QS-9000 quality standards are extensions of the ISO 9000 standards. An organization that qualifies for QS-9000 certification also meets ISO 9000 standards. Meeting ISO 9000 standards, however, is not sufficient for QS-9000 certification.
How does ISO 9000 help us do our jobs? How does it help us deliver quality products and services consistently? ISO 9000 systematically guides an assessment of our quality management system and process controls. It helps us look at how we make the product or deliver the service. It makes us ask, "What can go wrong, and how can we change the system to prevent it from doing so?"
Some companies' goal is to "get the ISO 9000 certificate so we can do business in Europe." They view the certification process as a costly annoyance. This is an error. The systematic assessment of the quality management system can improve productivity and quality, and help the company make money (Scotto, 1996).
This section will not discuss the details of ISO 9000, but will give examples of its applications.
Primitive tribes transmitted their lore orally, since no one could read or write. The "oral tradition" may have been the origin of poetry. The rhyming verses helped the storyteller or speaker remember what to say. This is not, however, how we want to run a manufacturing process. There must be written instructions and specifications to make sure that everyone does the job the same way.
Document changes are a common trouble source. Suppose that an operating instruction says to set a furnace temperature to 350 [degrees] C. A change in materials requires operation at 370 C, so the process engineer revises the operating instruction. What happens if he or she delivers the revision to the manufacturing area, but an old copy remains there? Someone may pick up the old instruction and set the oven to the wrong temperature.
ANSI/ASQC Q9002-1994's section 4.5, "Document and Data Control," requires procedures to prevent this from happening. It specifically calls for controls to "…preclude the use of invalid and/or obsolete documents" (ASQC, 1994).
Chapter 3 will discuss why archery was inherently superior to gunnery until the 19th century. Armies of the 15th and 16th centuries did not adopt guns because they were superior to bows, but because they were easy to use. Bows were better weapons, but it took years of training and practice to make a good archer. The 19th century saw the invention of breechloading rifles, which are easy to use and are more effective than bows.
One of the bow's advantages was traceability. The archer could watch his arrows in flight, and change his aim accordingly. If something was wrong with his bow, he would know it immediately. The archer's product- his shot- was traceable. He knew which arrows were coming from his bow, and which were coming from his neighbors'. The firearms of that era, like matchlock muskets, offered no such advantage. The bullet was invisible in flight, and provided no feedback to the gunner.
If our process is making defective product, we need to know where it is coming from. Do all the bad parts come from one workstation, or one material lot? Traceability is also a requirement for effective statistical process control (SPC). For example, each workstation should have its own control chart. To put a measurement on the right chart, we must know which workstation produced it. (This assumes that measurement or inspection happens after the part leaves the workstation.)
Process control includes the following.
Sections 4.10 and 4.11 of ANSI/ASQC Q9002-1994 govern inspection, testing, and control of inspection and testing equipment. Section 4.12 covers the product's inspection and test status. These sections' principal goal is to make sure of the following.
Suppose that a vehicle may contain crime evidence. The police have it in their custody, but someone manages to break into it. This compromises the reliability of any evidence the police may collect from it afterward. Similarly, we cannot rely on the quality of product that went through a gage whose calibration is questionable. A lawyer does not want to give questionable evidence to a jury, and we don't want to give questionable product to a customer.
In one of C.S. Forester's Horatio Hornblower stories, an English warship receives barrels of spoiled meat. Hornblower decides to exchange the barrels for good ones, but he suspects that the supplier may sell the bad ones to another ship. If the other ship's captain is in a hurry to sail, he won't find out until it is too late. Hornblower therefore orders two midshipmen to write "CONDEMNED" on each barrel with a hot iron. This is an example of segregation of nonconforming product.
Today, few people want to use or sell nonconforming material. (The unscrupulous ones who do usually don't stay in business very long.) There is, however, a chance of doing it accidentally. Suppose our incoming inspection department discovers a problem with a batch of incoming material. They put it aside instead of releasing it to the factory, but don't mark it. Someone from the factory needs this material, and sees the package in the inspection room. They may pick it up and take it into the factory. In the production area, someone may take rejects out of a box and put them aside. If they don't mark them as rejects, someone else may pick them up and use them.
Section 4.13 of the ISO 9002 standard requires suppliers to prevent accidental use of nonconforming materials. Methods for doing this include:
Here is an example of how an electrical tester prevents bad pieces from mixing with good ones. The tester sorts the parts into bins according to the parts' electrical characteristics. Rejects go into the reject bin (Figure 2-20).
Figure 2-20. Sorting of Parts by Electrical Tester
Readers of Tom Clancy's Red Storm Rising and Debt of Honor will be familiar with this issue. In Red Storm Rising, the Soviets transport antiaircraft missiles by ship to Iceland. Seawater (or salt spray) damages some missiles. While the Russians designed their naval missiles to resist salt water, they didn't do this for their Army missiles. In Debt of Honor, sea water damages some automobile gasoline tanks from Japan. Section 4.15 of the ISO 9002 standard would have been helpful in these situations.
Is the product perishable? Does it have a shelf life? Is it vulnerable to damage by heat, shock, or electrostatic discharge? Here are some practices for addressing these issues.
Other sections of the ISO 9002 standard include the following.
The Pareto principle applies to ISO 9000. A few program elements are the source of most of the problems. Robert M. Bakker of Entala, Inc. (Grand Rapids, MI) said that many companies that are seeking QS-9000 registration run into trouble with the following elements (Manufacturing Engineering, May 1996). (Remember that QS-9000 includes all the elements of ISO 9000.)
The chapter's problem set includes six simple examples of factory procedures, and asks readers to decide whether they're acceptable under ISO 9000. (The material in this section equips readers to answer these questions.)
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