8.3 Control of Nonconforming Product

What is meant by nonconforming product? If we go back to the definition of quality being conformance to requirements therefore, nonconforming is not meeting the requirement. This is a go/no go issue. It’s determined through testing and inspection. There are five possible choices in dealing with nonconforming product:

1) Reject

2) Rework

3) Repair

4) Regrade

5) Release

Which one of the five that is used depends on the product itself, the customer, the industry and of course the cost?

8.4 Analysis of Data

Here is where you decide what data will be analyzed to effectively measure performance and identify areas for improvement. The information from this clause will provide empirical (factual) data that can be used to determine progress and make management decisions.

You should collect and analyze all the data that will let you determine process and system effectiveness. And, then figure out where improvement is needed. At the very least you will need to provide and analyze data for these four issues:

1) Customer satisfaction,

2) Product quality,

3) Product and process trends, and

4) Supplier performance.

8.5 Improvement

8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action

Although you have planned, implemented, controlled and measured your processes sometimes things go bad. Usually we give it a quick fix and life goes on. However, once in awhile the mistake is serious. Customers are angry and dissatisfied. Internal costs are getting out-of-hand. The most serious mistake causes injury to people. Something needs to be changed. The QMS needs to be corrected or improved.

Before you can change the QMS, you need to know which problems need the most attention. You need to focus on the BIG problems. The small stuff will probably take care of itself during the course of normal activities. The important thing here is to figure out the difference between the small and big problems.

Many times the only criteria a company uses is which wheel squeaks the loudest. Everyone runs around in frantic action constantly putting out fires. You need to develop a method to evaluate which problem comes first. Perhaps using cost, risk to customer satisfaction or compliance with regulations, or current events (those things your company or group are currently focused on).

If the kick-in threshold is too low you see every problem as an immediate crisis. If the threshold is too high it will let serious problems continue and eventually close you down.

There has been an ongoing debate over the difference between corrective action and preventive action. The generally accepted explanation is if a problem has occurred, corrective action is needed.

If the problem has not happened, but could, preventive action is needed. The potential severity of the problem needs to be determined so a decision can be made. Since no company has enough resources to address everything all at once, a priority must be set.

Whether you need corrective action or preventive action, the method for taking the action needs to formal and disciplined. Flowcharting, data analysis, and root cause analysis are some of the methods that can be used.

What if there haven’t been any serious problems in the process? Is action needed? The answer is a definite maybe. Those processes that are critical to producing an output for your customer should be analyzed for continual improvement. Raise the bar a little. Figure out how you could reduce cycle time, increase throughput and maybe improve yield. Continual improvement doesn’t need to be a home run or grand slam every time. Small changes on a continuous basis can have a tremendous impact.