ISO 9001 Section 8
Measurement, Analysis and Improvement

ISO 9001 Section 8 - Measurement, Analysis and Improvement

8.1 General

This clause asks you to do 3 things:

1)  Identify the important measuring processes,

2)  Use the data to make sure things are okay and to  make them better,

3)  Determine where you need to use statistics

You need to determine the information you need to collect and how to use it. Ask if the right information is being collected and if it is useful. Many companies collect and keep data that has no value. Others fail to analyze data that can provide insights for valuable improvements.
Get a picture of your data and information plan by identifying the sources of the data, how the data are collected and where the data goes. Data may come from measuring product characteristics, process performance, audit results, complaint reports, customer surveys, etc. It can be useful to flowchart the collection, use and analysis of data.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

This clause reinforces what the standard is all about. Remember from earlier in the discussion that the customer defines quality? Companies have two types of assets, tangible and intangible.
Tangible assets are the physical things they own like buildings, machinery, automobiles and everything else that is real. Intangible assets aren’t physical things. That can’t be touched or seen. Things such as goodwill, brand recognition, market position, customer loyalty.

8.2.2 Internal Audit

Auditing is one of the four primary controls specified in the standard:

1)  Planning your processes

2)  Controlling your processes

3)  Examine your processes (auditing)

4)  Correct or improve the process.

These four controls are the basis of the Plan – Do – Check- Act cycle. Therefore, auditing is a critical function in your QMS.
The first thing you need is an audit schedule. The schedule shows what processes are to be audited, when they are to be audited and who will be the auditor(s). The audit schedule should be developed and published by the lead auditor or audit program manager. It should cover a year’s worth of audits. Although this isn’t required by ISO 9001 it has become an industry guideline. At the very least the schedule should cover 6 months, but 1 year is preferred.

8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of product

One of the primary rules of quality is “Do it right the first time.” The processes for providing product must be monitored and measured against an acceptance criteria. A company should know when processes are operating effectively. If the production and delivery processes are performing okay, it is likely to result in acceptable product and customer satisfaction.

Product quality is defined as conformance to requirements. These are measurable features and need to be verified through inspection and test procedures. The three most common product inspections are:

1)  Receiving inspection,

2)  In-process inspection, and

3)  Final inspection.

These are the classic quality control concepts used for years by companies. They provide us with the data to show the customer that you are making product to the requirements. The amount of inspection will decrease as your processes become more capable through continually improvement activities. However, some inspection will always be necessary.

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 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. 

Additional Information Resources

ISO 9001 Section 4: Quality Management

ISO 9001 Section 5: Management Responsibility 

ISO 9001 Section 6: Resource Management

ISO 9001 Section 7: Product Realization

What are Quality Management Systems?

What is ISO 9000?

What is ISO 9001?

What is ISO 9004?

What is ISO 19011?

ISO 9000-2008 Changes

Online ISO 9000/9001 Overview Course

Auditor Training: Online

Auditor Training Courseware