Does Your Corrective Action Process Really Work?
When a deficiency in your quality management system is discovered, is it documented and thought of as a good thing? One of the most common problems I have encountered as a third party auditor and consultant is the fear of Nonconformance’s. During initial presentations to a company, particularly if I have senior management in the room, I will ask about their corrective action process, how it’s working for them and how many nonconformance’s they document in an average month. A typical answer is a very proud indication that they have a great corrective action system and they generate very few nonconformances. That is a self-contradicting statement.
Chances are very good that nonconformances are seen as a bad thing in these companies and the person responsible for this horrible offense is hunted down and profusely reprimanded for such callous offenses. Does this sound familiar?
Let me set those who still feel that nonconformance’s are bad, THEIR NOT! If you find 3 things going wrong within your organization this week, and resolve them so they never happen again, do you think you have improved your company’s performance? Hello McFly, guess what the bonus is – there’s a pretty good chance you will improve your bottom line as well! So get out there and find as many nonconformances as you can. You have nothing to lose and everything to gain. Remember, the whole idea is to continually improve your products and processes so that you can compete and grow.
Root Cause Analysis and Continual Improvement
Root cause analysis is a class of problem solving methods aimed at identifying the root causes of problems or events. The practice of root cause analysis is based on the belief that problems are best solved by attempting to correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. By directing corrective measures at root causes, it is hoped that the likelihood of problem recurrence will be minimized. However, it is recognized that complete prevention of recurrence by a single action is not always possible. Thus, root cause analysis is often considered to be a repetitive process, and is frequently viewed as a tool of continuous improvement.
Root cause analysis, initially is a reactive method of problem detection and solving. This means that the analysis is done after an event has occurred. By gaining expertise in root cause analysis it becomes a pro-active method. This means that root cause analysis is able to forecast the possibility of an event even before it could occur.
A well implemented quality management system will include training and understanding of how root cause analysis tools and techniques can be used to promote continuous improvement.
Sustained Success, What Does It Take?
The new version of ISO 9004 is based on the principle that satisfying customers may bring success, but to sustain success organizations need to go the extra mile and satisfy the needs and expectations of all interested parties. It is an attempt at relating quality management principles to the quest for sustained success in an organization, but it does not add anything new by way of management principles. It is portentous that sustained success can be achieved by clever application of the eight quality management principles through a system of practically managed processes that:
- Continually monitor and analyze the organization’s environment
- Define the needs and expectations of interested parties
- Create and maintain a mission, a vision and values consistent with the needs and expectations of interested parties
- Clearly specify, implement and communicate a strategy and policies for fulfilling the mission and vision which supports the values
- Identify, provide and manage the internal and external resources needed for the achievement of the objectives in the short and long term
- Provide products that will continue to meet the needs and expectations of customers and other interested parties, on an ongoing basis.
- Regularly monitor, measure, analyze and review the performance of the organization
ISO 9001 Don’t Survive, Thrive!
Why is it that when times get tuff most companies invest most of their time and money in short term short sited goals? The ultimate goal of any company should be more than just survival; it should be forward thinking total sustained success. How can a company reach for and attain sustained success with the economy in such distress? The best way is to invest in continuous process improvements that result in cost reductions and increased market share.
Becoming certified to the industry standards that your industry leaders are requiring is the surest way to stand out and get noticed. If your competition is already certified to ISO 9001, AS 9100, RC 1400, ISO 1400 or some other industry standard, they have a decided advantage over you and how much more business they will receive as a result of this certification. If you are certified, how well you manage your business processes can help or hurt your progress toward sustained success.
Many companies go after certification to satisfy a customer request or simply because they believe it the right thing to do. However, the majority of the organizations that embark on the road to certification, go into the process ill equip and ill informed. The result of such endeavors usually produces a business management system which may ultimately result in certification, but offers no advantages and becomes just another expense to absorb.
My advice, get educated, hire a competent business management consultant if you fell you need one, and make your business management system your own. Every business is different and so each business management system should be unique as well. Don’t waste hundreds of thousands of dollars and years of consulting fees to reach you goals. Take ownership of your system and make it a transparent part of your everyday work experience. When a well designed business management system is implemented, it is effortless and provides real tangible benefits that result in sustained success. Don’t survive, thrive.
Time Saving, Money Saving ISO 9001, AS 9100 Alternatives
There are now products and services available that make it possible to work together with one or more of your staff online to create and write or revise the necessary procedures that are required by an ISO 9001 or AS 9100 system. Your staff can be at different locations or even at their own desks within your company. There is no need to meet in a conference room, since the conference room is virtual (on the Internet). This approach reduces costs dramatically and results in a better and more efficient working relationship.
First, this technology makes it possible to work at your pace and at your schedule to meet the project’s deadline;
Second, there are no flight, hotel or meal costs! Huge cost reduction;
Third, you can work with your ISO consultant and multiple managers at your facility or at your facilities across the nation in one meeting;
Training is the most important feature of any management system. The better trained the better performance you can expect from your staff. This technology can also make it possible for your ISO 9001 consultant to provide training online to one or many of your employees at the same time. This training can be at your schedule and because the training is performed online, there is no travel, hotel or other expenses.
ISO 9001 Is Steeped With Myths and Misconceptions
Why do so many companies shy away from becoming certified to ISO 9001? For one thing, ISO 9001 is steeped with myths and misconceptions. Let’s examine some of these.
- Perception: My Quality Manual has to plagiarize the ISO 9001 standard: False, if you have referenced the standard in your manual, why would you need to recreate it again? What would be the purpose? The only requirements stated in the new ISO 9001:2008 standard are: a scope which includes any exclusions you may have, the procedures or reference to the procedures for your management system and complete description of the interaction between the various processes that are required to operate your business.
- Perception: I must have a document (work instruction, flow chart, procedure, etc.) for every process in my company: False, The extent of the documentation that your organization will require depends on the size and complexity of your organization and how well your employees are trained to do their jobs. The only time a procedure is required is when someone cannot do their job without it. If your procedures are collecting dust, get rid of them, they will come back to bite you.
- Perception: Implementing and maintaining ISO 9001 is expensive: False, a quality system done right is both a money saver and time saver. The use of ISO 9001 software and other tools have made the job of implanting and maintaining a well run quality management system an effortless task.
- Perception: The ISO 9001 system is a Quality System (belongs in the quality department or is the responsibility of the quality manager), or many organizations feel they need to hire somebody full time to manage the ISO 9001 system (internal audit coordinator, corrective action coordinator, ISO coordinator, etc.): False, the quality management system belongs to everyone in the organization and can be assigned to any individual within the organization. Many companies assign the plant manager or supply chain manager as their management representative. Keep in mind this system belongs to everyone and everyone must participate to make it successful.
ISO 9001 Documentation
The first step in implementing an ISO 9001 system is to document your management system by developing the required documentation which consists of a quality manual and six required procedures:
1. Control of documents
2. Control of records
3. Internal audits
4. Control of nonconforming product
5. Corrective action
6. Preventive action
The ISO 9001:2008 standard also allows you to further simplify you documentation by combining some of these procedures:
- Control of documents and records
- Corrective and preventive action
So, instead of six individual documents you might have four. Now, depending on the size and complexity of your organization and your employee training programs, you will need to add any additional procedures necessary to meet your organizations objectives and customer requirements.
Documentation can sometimes become a mine field during a registration audit because some organizations over document their system because they believe they have to detail everything. If your organization has little or no ISO 9001 training it is best to get training or hire a good ISO 9001 consultant who can help you develop your quality management system documentation. Don’t just spin your wheels, get help and save time and money!
Making the Grade
Once your business has been up and running for a few years, it is easy to take some of the day-to-day practices for granted. Often times, people will become complacent and important details may be overlooked. One of the best ways to check the status of your company and ensure that all of your ducks are in a row is with an ISO Internal Audit.
Through this auditing system, you will get an objective view of all of your business practices and record keeping. There are several companies that provide certified third-party auditors that can help you get a gauge on your business and point out areas that aren’t up to snuff. No matter what product or service you are providing, it is important to maintain quality records and documentation, and an internal audit can ensure that you are doing just that.
RC14001 Above and Beyond
RC14001:2005 incorporates all of the requirements of ISO 14001:2004 as well as the requirements of the Responsible Care® code. It is the ideal standard for chemical manufacturing companies who want a certified system based on an international standard that is accepted by all types of organizations worldwide.
RC14001® aims for continual improvement and demonstrated product stewardship. The third-party verification further provides credibility, ensuring continuing conformance to all requirements and expected EHS&S performance. There are business management software providers which have excellent template procedures that meet and exceed the requirements of ISO 14001 and RC 14001 for Environmental, health, safety and security to help you fast-track your system!
A Better Way to Manage Internal Audits and Management Reviews
Many organizations struggle with how to manage and maintain their internal audit and management review processes. While no one sets out to deliberately miss manage these processes, they can take on a life of their own. So, how do you better manage these processes? The ISO 9001 standard does not expressly tell you how, but it does tell you what is expected. Does the standard say you have to actually meet to satisfy this clause of the standard or does it tell you that you have to review the necessary criteria at set interval? If it were possible for top management to review all of the in-puts and out-puts of a management review and assign actions with follow-up, without actually sitting in a meeting, how much more time could be spent on actually improving your systems?
Meeting/audit module in CIS Software is a powerful management action item tool and may be used for many other functions other than just meetings and audits. Because of its design and ability to assign action items to a manager or group of managers and to follow-up on these action items until completion, this module is truly invaluable.
By using the meeting/audit module, there is no need to hold follow-up meetings to review and ensure that previous action items from a meeting or internal audit were completed. Since holding these follow-up meetings is the normal management approach in most organizations, this module alone will cut your valuable meeting time by more than 30 %.
Furthermore, the meeting/audit module includes special tools for Process Auditing. Since the management meetings are all shown on the master calendar and audits may be scheduled monthly, quarterly or yearly, the internal audit plan is always at the click of a mouse. Furthermore, the auditor and auditee is always informed of these audits on their personal calendar and on the master calendar