Featured Book of the Month:

Title: Quality Audits for Improved Performance

Author: Dennis R. Arter

Publisher: ASQ

Notes: A single source of information on the basics of quality auditing. It includes ideas and techniques, based on ISO 9000. Every step of an audit is covered and supported with examples, making this book an ideal reference. (Notes taken from ASQ)

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You can order this book from internal-auditor.com at: http://www.internal-auditor.com/books.htm

This Month's Feature Article

Continual improvement is a requirement of both ISO 9001:2000 and ISO/TS 16949. It also makes good business sense. As internal auditors we need to be able to audit our organization's continual improvement process(es). We need to be aware of what continual improvement is and what it is not. We also need to be able to determine if our organization's continual improvement process is effective. 

ISO 9001 states: "The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review." (8.5.1) Of course, what the standard doesn't say is "how" you are supposed to do this. 

ISO 9004 gives some good advice on implementing continual improvement. As auditors we should read this for ideas on the subject. Remember that part of our job is to make recommendations, and ISO 9004 is not mandatory, but for guidance.  At the same time, we must remember that our job is not to make management decisions, but to verify decisions made, and make suggestions.

Let's take a look at the various parts of ISO 9001, and look at how to audit each section. 

Quality Policy

Clause 5.3 b) states that the quality policy  "includes a commitment to comply with the requirements and continually improve the effectiveness of the quality management system,". As internal auditors, we look at the quality policy as a guide for the overall continual improvement strategy. The quality policy needs to set the ground work  for the balance of continual improvement efforts. There should be some reflection of the policy in our continual improvement efforts, and those efforts need to support the quality policy.

Quality Objectives

The quality policy also sets the framework for the quality objectives. Although continual improvement is not specifically mentioned in 5.4, quality objectives are mentioned in 8.5.1. It also makes sense that if the quality policy establishes the foundation for continual improvement, and the framework for the quality objectives, then continual improvement and quality objectives are directly linked. The internal auditor needs to look for that link, and evidence that the quality objectives support the quality policy and continual improvement. 

Audit Results

As mentioned before, part of the job of internal auditors is to make suggestions. This is one way that internal auditing is used to facilitate continual improvement. However, the connection between internal audits and continual improvement goes much farther. Part of the "planned arrangement" and "effectively implemented and maintained" mentioned in 8.2.2 includes 8.5.1, Continual improvement. Continual improvement is an integral part of the Quality Management System, and therefore is part of internal auditing. The organization uses audit results (from internal and external) to evaluate the continual improvement process and continually improve that as well. 

Analysis of Data

One of the 8 Quality Management Principles is the use of "Factual Approach to Decision Making". Clause 8.4 states that the organization will analyze data in part "to evaluate where continual improvement of the effectiveness of the quality management system can be made." In order to to this, the organization must have data to analyze. Then they have to actually analyze the data they collect. As internal auditors, our job is to verify that data relating to continual improvement is being collected and analyzed. From a compliance stance, we are less concerned with the type of data, we just need to make sure that the data is being collected and analyzed. Once again remember, we are not here to make management decisions. 

Metrics

In order to have improvement, you have to know where you currently are, and where you have been. Proper metrics allow for continual improvement to be structured and monitored. Metrics selected for continual improvement measurement need to support the quality policy and quality objectives. Once again, ISO 9004 gives some good input on possible things to measure. Below are some additional ideas from the Michigan Manufacturing Technology Cener.

Bear in mind that these are things that might be useful in continual improvement. They might also be helpful in making suggestions, but they are not required. If we feel that the data selected is inappropriate, we still might not be able to write a nonconformance. 

Methodology

Deciding what data is to be collected is one thing. The organization must also decide on how the data will be collected (including who will collect the data), and how the data will be analyzed.  Again, these are management decisions. As internal auditors, we need to ensure the data selected is being collected and analyzed. 

Corrective and Preventive Actions

It is hard to think of corrective action being part of continual improvement, but it is. Effective corrective action results in no recurrences, and that is a form of continual improvement. Likewise, preventive actions are continual improvement actions as well. Internal audits should look at the corrective and preventive actions processes to ensure they are effective. This does not have to be part of the continual improvement internal audit, but the internal audit should review the previous audits of the corrective actions and preventive actions.

Management Review

This is the key to continual improvement. Improvement is mentioned in 5.6.1, 5.6.2 and 5.6.3. This is in part because continual improvement will not occur without top management's direction. Management must ensure that continual improvement becomes an integral part of the QMS, and each activity is aware of the importance of continual improvement and builds it into their own processes. This should be reflected in management review, and management review records should indicate this. 

Summary: 

Auditing continual improvement is an everyday part of internal auditing. As we audit our systems, processes and departments, we need to determine what is being done to continually improve that part of the system, processes or department. But we need guidelines as to what the organization feels are the targets for improvement that apply to that specific activity. It is an easy step from there to determine if the organization is following their own plan, and if that plan is working. Auditing will easily tell us that.

As always...Good Auditing!

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www.mmtc.org 

Q – What is the difference between Preventive Action and Continual Improvement?

A – Excellent question! To many there is little difference, however a close examination will reveal that they are completely separate. Preventive Action focuses on preventing a potential failure. The concept being that without the preventive action, a failure is more likely (or even certain). Continual Improvement is making things that are currently working better. Failures, or potential failures are not necessarily considered. There may be times when one blends over into the other, but the focus of each is independent of the other. In order to have a healthy organization, both preventive action and continual improvement needs to be part of the overall strategy.

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With ISO 9001:2000, and ISO/TS 16949:2002, you are required to have a lot less procedures than with the earlier versions. So, the question often comes up about what to do with your old procedures. Here is a thought from one company.

Seeing as though a we must look at our QMS as a process-based system, and seeing as though a procedure is nothing more than the steps to enact a process, then procedures need to be considered. Your procedures may change, you might delete some, but you might have to add some. By examining your processes, you can determine which procedures need to be formalized, and which do not. Even though the new requirements mandate less documented procedures, you might end up with more documented procedures than you already have. 

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ISO 9001:2000 Clause 8.5.1 Continual improvement

"The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objective, audit results, analysis of data, corrective and preventive actions and management review."

"Product information" is a critical part of the communication between an organization and its customer(s). In making the "effective arrangements" for communication, the organization must first understand all of the points in which there is communication (in either direction) regarding product information. We tend to think of only the sales, or complaint ends, but it goes much deeper than that. At what stages, and at what points at each stage does the customer communicate product information to us, or we to them. Your arrangements must include all potential instances of product information communication.

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November  2002’s question:

You are interviewing the purchasing manager. One of the stated quality objectives is to reduce lead times on orders. When asked how the purchasing manager’s job and personal objectives support that objective, the purchasing manager states that her performance objective for bonus is to reduce costs. She is aware that sometimes the two are at odds, but the default must be to her performance objective. “After all”, she explains, “if lead times are really a priority, then my performance objective would reflect it.”

The answer:

This is not an unusual. Unfortunately, most internal auditors do not have the ability to look at individual performance objectives.  5.4.1 requires quality objectives to be "established at relevant functions and levels of the organization". In this scenario, the personal objectives do not support the quality objectives. Her final comment is valid, and indicative of quality objectives not being properly established at relevant functions and levels. A nonconformance is warranted.

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Feeling Pain

As more and more time passes, I become greater convinced that the driving force behind organizations is not money. I think the real motivation of companies is pain (or lack of). Companies change only when the pain of inaction exceeds the pain of action. Until they reach that point, any attempt in getting the company to change course will meet stiff resistance, and ultimately fail. The organization will use finger pointing and blame as a means to cope with the pain, but they are only temporary and the pain will return, often in increased intensity. Yet, companies are slow to find the true cause for pain. Perhaps it is because they know deep down what that root cause is and they just don't want to deal with it.

As internal auditors, our job quite often is to uncover and name organizational pain. This is even more true when we are auditing to drive continual improvement. We must be conscious of the pain we uncover, and try to eliminate the possibility of it turning out to be a blaming party. We can best do that through carefully worded nonconformances and by properly "selling" the nonconformances we find.

Dave

...Good auditing!

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Because this site uses information from many different sources, it must be pointed out that any advice, tips, information, etc., provided should be regarded as opinion and not fact! What works well for one company may be a disaster for another. Also, what one registrar, or auditor may allow, another may not. As always, reflect on what you read, see if it fits into your own quality system, and if it conflicts with your auditor...you've got to make a decision