Preventive Action

Many organizations struggle with how to determine what constitutes a preventive action. To determine what should trigger a Preventive Action investigation, ask the question “What If”.

What if weI only have one piece of equipment?
What If we only have one set of tools for a critical process?
What if we only have one person with the skills to do a certain process?
What if one of our key suppliers goes out of business or is destroyed by a natural disaster?

Any of these criteria may point you to a potential opportunity for a preventive action. When investigating a preventive action it is important to identify all the risks and costs of having the problem and weigh it against the likelihood of it happening. The benefit to the process and or company if you were to implement the improvement and the legal and ethical reasons for implementing the action regardless of the cost or potential benefit should always be considered prior to implementation. ISO 9001 software and as9100 software packages can aid you in collecting and evalateing this information you gateher from this prcess.

The Goal Of The AS9101 Rewrite

The AS9101 rewrite goal is to provide requirements on process auditing and development of AS9100 series audit approaches and tools that focus not only on conformity, but also on effectiveness of a AS9100 quality management system (QMS). The AS9101 proposal is to develop an enhanced audit process for evaluating process-based management systems that aligns with ISO 17021 and consists of:
• Process-based information gathering.
• Assessment or analysis and audit planning.
• Development of performance-based and process-oriented audit methods and techniques.
• The ability to capture objective evidence of process conformity and effectiveness.
The major proposed changes in the rewrite of AS9101 include:
• Creation of one document covering AS9100, AS9110 and AS9120.
• Elimination of scoring and key requirements designations.
• Use of data and customer feedback concerning organizational QMS performance as an input for process-oriented audits (for example, Online Aerospace Supplier Information System (OASIS) customer satisfaction or performance scores).
• Inclusion of determination of effectiveness, in addition to conformity.
• More emphasis on performance measuring.
• Introduction of the objective evidence record.
A major theme of the AS9101 rewrite is examining process effectiveness. ISO 9000:2005 defines effectiveness as the extent to which planned activities are realized and planned results achieved. The ultimate measure of QMS effectiveness is customer satisfaction.
What has not changed in AS9101 includes determining conformity to the standards, documenting discovered nonconformities and drawing conclusions on conformity of the organization’s QMS based on information collected during the audit.

AS9100 Why are The How To's Left Out?

AS9100 defines additional areas within an aerospace quality management system that must be addressed when implementing an ISO 9001:2000-based quality system. Typically, these requirements are included within strong aerospace quality systems. The industry experts who wrote the standard and the representatives who approved it all agree that these additions are essential to ensure product, process and service safety and quality.

Although the standard outlines industry "what’s" for a quality management system, the "how tos" were purposely left out and remain the responsibility of those developing the system within the organization. This reflects the AS9100 writing team's, and my, belief that providing a set of “how-to” information, stifles continuous improvement.

All quality systems must be designed to meet the specific needs of the users. And although AS9100 categorizes areas to address within the aerospace industry, system developers are encouraged to first establish a strong quality system that's both effective and efficient. This system should be a holistic unit with practices spanning multiple functions and processes within the business.

Business Process Improvement Through Communication

All of us have been in a business process improvement or sales meeting where the speaker clicks through a PowerPoint presentation showing charts and numbers. Few people, if any, take anything away from those meetings. But put the same information in the context of a story and the point is made.

When you tell a story, people understand what the mission is and they understand how they can make it happen. If you just talk at a high level of mission and vision the reaction is, "What am I supposed to do with that!?"

So, how you communicate and what you do after that communication is made is without a doubt the most improtant part of setting the agenda for your budding AS9100 or ISO 9001 quality management system. Letting your employees know what their part is, can absolutly make your business management system a success. Get out there and show your organization this is not just another program. This is a way of doing business, and it is here to stay, so get on board.

Business Management System Tools For Today

We will devote this page of the blog to new and inventive ways to manage your business management system. We will discuss software trends and other time saving tools that will make developing and maintaining your quality management system both cost, and time effective.

You are invited to contribute your ideas and knowledge so that everyone may benefit from this blog. All though I am a consultant, I am very serious about working together with all that are interested in driving continuous improvement and the betterment of our community. If everyone who comes here, contributes just one idea, just think what we can do together.

Some small businesses cannot afford six figure consultant fees to help construct a quality management system that complies with the standard, and meets their indiviual needs. This is why these new tools are so improtant and should be shared and discussed openly.

A Time to Improve

Since the goal of ISO certification is to ensure that your company meets standards for quality management systems, your focus should be first and foremost on quality and not the certification itself. Your company should not try to get ISO certified for the sake of being certified, but rather look at it as a way to improve your company’s efficiency and quality processes. Before seeking certification, review your company’s procedures and processes. I dentify disparities between procedures and what is actually done. If what is actually done is more efficient than the written procedure, you should update the written procedure rather than conform to the less-efficient guidelines.

Any good business management system should keep adequate records, and they are essential for ISO certification. One of the required documented procedures is one for controlling records – what identifies every record, how they are stored to protect them, how they are cataloged or organized, how long you keep them, and how you dispose of them. Spend some time reviewing your procedure and examining whether your management follows it; then decide which procedure is the most efficient and appropriate for the nature of each record. This is a time when you can eliminate unnecessary processes, create new ones, identify mishandles processed and make record-keeping more efficient overall. Approaching it from a self-improvement standpoint will be much more effective and pleasant than trying to cover up mistakes that have been made before an ISO audit.

The difference between Corrective and Preventive Action.

Corrective Action is based on a nonconformance event that has happened in the past. Preventive Action is based on preventing a nonconformance event in the future. Both are analogous procedurally, but with the focus as described. Together, Corrective and Preventive Actions—typically referred to as CAPA, are fundamental parts of a continuous improvement program.

Both sub-systems require some type of a log to record each event; a Corrective Action Log and a Preventive Action Log. Each Corrective and Preventive Action will normally have a form that is used to record the details of the activity performed to satisfy the incident; A Corrective Action Request, a Preventive Action Request.

Bothe corrective and preventive action processes are interagul to iso 9001 training programs. The more effective your emplyees are at identifing, correcting and preventing non-conformance the better you bottom line will become.