Posts Tagged ‘quality management’
ISO 9001 Done Right, Done Wrong, What is the Ultimate Goal?
I have had the chance, as a consultant and Lead QMS Auditor, to see ISO 9001 in companies big and small in many industries such as manufacturing, service, technology, aerospace, warehousing and others. I’ve grown to understand a few things that seem to make all the difference in how ISO 9001 impacts an organization, either positively or negatively.
In the worst of circumstances, some companies regard their ISO 9001 certification as an accessory that has been uncomfortably inserted into the fabric of the organization. In these companies, ISO 9001 is something to present to an auditor once a year. When the annual audit comes due, everyone rushes around to tidy up the place because “we can’t allow them to see how we really live”. Somehow they placate the auditor enough to come away with an extensive list of corrective actions to address, while still retaining their certification. Once the auditor leaves, the “QMS” is quickly shoved aside so it is out of the way of the “actual” business that needs to get done.
Somewhat better are those companies who at least try to keep up with everything through the year unless an “emergency” comes up or everyone becomes too busy. Unfortunately the crisis-of-the-month and the too-busy-with-the-customer excuses are quite routine and, worse, acceptable justification to “work around the system”. In too many cases these short term lapses become the standard operating procedure. Once the dust settles things get mostly caught up until the next “all hands on deck” is signaled. These companies commonly think of ISO as a “necessary evil” that has to be tolerated.
On the flip side, there are a significant number of ISO 9001 certified organizations who appear to “get it” when it comes to achieving real value from their ISO 9001 quality management system and have incorporated it into their daily business processes. In these companies, the management team has learned how to use the requirements imposed by the standard to their advantage by solving real problems and consistently achieve real improvements in business objectives. These organizations actually achieve real benefits by using the standard as a lever for improving both customer satisfaction and their own bottom line.
I have worked with many ISO 9001 success stories over the years and have come to realize that there are a few unmistakable similarities in how they were able to reached their goals .
In either case, the “magical prescription” to achieve genuine value from IS0 9001 are a direct result of:
- Keeping it simple (K.I.S.S)!
- Focusing on business importance!
- Never doing anything just to please an auditor!
My Customer Wants Us Certified to AS9100, HELP!
You are a small business owner who has just been told you must become certified to AS9100 in order to continue to receive business from your largest customer. You have been putting this off for some time, hoping you would be able to wait until the economy gets better. Now what, you have a deadline and you haven’t got a clue how to get there from here? The best advice, find a competent consultant and get some training to the standard.
Those organizations who recruit good consultants get the job done roughly twice as fast. By helping you avoid mistakes, a good consultant can help you get the job done faster. But only a good consultant can do this. Not all consultants are created equally, and it is important to select a consultant that is right for you. A reputable consultant works hard to ensure that you fully own your quality management system at the time of registration. Key services you will require, if you have no idea what you are doing or how you will do it are as follows:
1. Required documentation development and implementation
2. Training: Quality policy and objectives, Management review, Corrective and Preventive action, Internal auditing, AS9100 Overview, Risk analysis, Overview of the Complete QMS, Collecting and analyzing data.
3. If software is being used to facilitate and run your quality system, you will also need training and implementation services for this.
4. Implementation of a competency, awareness and training program, internal audit, corrective and preventive action programs, management review and overall continual improvement programs.
5. Conduct internal audits for entire system (all processes), one high level internal audit to the AS9101C checklist in preparation for registration audit.
This is just a short list of services that you may need to accomplish your goal of certification to AS9100. Depending on the size and complexity of your organization and processes more may be needed. A good consultant can help you determine your individual needs.
ISO 9001 Horror Stories
Some of the horror stories about ISO 9001 implementations include companies who have binders of procedures, work instruction, and forms (generally with a layer of dust on top) and have been trying to implement ISO 9001 anywhere from one to five years unsuccessfully. Some have spent fifty-thousand dollars and others more than two hundred-thousand dollars on internal resources and/or consultants. Some have had a prior quality manager that wrote a management system for them and then left the company and no other employee knew how to continue the quality management system requirements. Some have gone through three quality managers each of them defining, adding to the last management system, or changing requirements that result in confusion.
In many instances, we find that companies who have invested considerable time and money in the process of certification that they have a hard time letting go of it even when it has proven not to be effective or useful for them. A company must decide if they want to chase bad money with good money when faced with this problem. If you are one of these companies, consider letting the existing management system go and documenting a new and effective management system from scratch.
How many of you have an ISO 9001 implementation horror story to tell. The fact is there are far too many of you. This is your opportunity to share your story with other organizations that are just starting out. Sharing your story may help someone else avoid the pit falls of your experience and reap the rewards of your eventual success. Lets not act like capital hill, now is the prefect time to show solidarity and help our economy move forward. With each success there is a certain amount of blood sweat and tears that goes along with it. If it is possible for us to help just one organization become stronger by our lessions learned, this is the time and form to share.
What Should You Look For When Selecting ISO 9001 Templates For Your QMS?
ISO 9001 templates are the fastest, easiest and most cost-efficient way to begin your ISO 9001:2008 implementation. But let’s be perfectly clear, buying a set of templates and inserting your company name in them, “WILL NOT” make your company ready for certification. ISO 9001:2008 is more than a set of required procedures; it is a whole business process management system which is unique to each organization. The finest ISO 9001 templates can provide substantial advantages that will save time and money, but organizational participation and commitment to the success of the quality management system is the driving force which separates the successful implementation and maintenance of a quality management system from the unsuccessful.
There are many templates out there that promise certification, which may or may not happen depending on how the templates are implemented and the degree that an organization customizes them to fit their unique business needs. Make sure that the templates you select provides, at a minimum, the following:
- A Quality Manual
- All required procedures
- Flow charts for generic processes
- Training materials to help customize the templates
- Templates that are designed to highlight requirements that the company can customize.
- Forms- Internal Audit , Management Review , Competency, Training and Awareness , Corrective Action, Risk Assessment for Preventive Actions
- Consulting services to help customize the templates to meet individual needs (Should be included in the cost).
One last thing, make sure that the templates you are buying were designed by a professional with hands on experience implementing and auditing to ISO 9001:2008 quality systems.
ISO 9001:Why Do You Need Procedures and Process Control?
Why do you develop and implement policies and procedures in the first place? By adopting policies and procedures, organizations are generally trying to tackle one or more of the following organizational requirements:
- Decrease training time;
- Increase consistency;
- Fulfill compliance requirements for ISO 9001 or some other standard;
- Risks management assessment;
- Improve Communications, internally and externally;
- Preserve and convey knowledge;
- Document continual improvement and manage change;
- Decrease non-conformance rate;
- Streamline access to information; and/or
- Make duplication and growth easier.
If your organization is struggling with how to get started with documenting and organizing your quality management system, you’re not alone. As a Quality management consultant and lead quality management systems auditor, I see so many companies who just don’t get it. If you do a poor job documenting your quality management system you’re in for a lot of pain and heart ache. A competent auditor can tell in five minutes if an organization understands their own system.
So why not start with a firm understanding of how to develop and maintain your system, sounds like common sense, right? If you need help there are many consultants and training programs that can help get you started. Choose wisely and you will find that not only will you be prepared for certification, but also you just might make the improvements that do save money, time, and pain.
What Happens Now That I Have My Certification?
At last we have attained certification, boy am I glad that is over. If this is what you are thinking right now, you have missed the point. Certification to ISO 9001, AS 9100 or any standard does not have a start and end point, (Implementation and Certification). Becoming certified is a continuous process which if implemented and attained correctly, with the right mind set, will result in lowering costs, and ongoing improvements for your business.
Never think that once you have reached your goal of certification that you are finished, now the hard part begins. Now you must live your quality management system day in and day out. Your processes must continue to be audited and improved, tracked and reviewed, trained and understood by all. This is your chance to reap the rewords of your planning, doing, checking and improving to become a world class organization and not just a another company with a certificate on the wall.
If you truly want to get the most out of the money and time spent to get that certificate, I suggest that you focus your attention on maintaining your system to reach peak performance. You will save money, improve relations with your customers, and knock the socks off of your competition. So why not take this certification and make it work for you?
The Templated Quality System: Mistakes Made
Time and time again I walk into an organization to audit their quality management system and I find that the overall processes and controls are well understood and executed, but the documentation just doesn’t match actual practices. Templates are great tools to help an organization meet the documentation requirements of ISO 9001, AS9100, or any standard. The problem is, most companies buy the templates and insert the name but never modify the templates to their particular processes. The results from such miss use of this tool are non-conformances found during a surveillance or registration audit.
Templates can help save time and help an organization cover all of the requirements of the standard, but they can hurt and organization if they are not used properly. Plan your processes and understand the standard that you have chosen to become certified to. Knowing what is required and what is not can help you to modify the templates to reflect your organizations actual practices. Most non-conformances, about 90% to be exact, are written against what the organization has required of itself or documentation that does not match the processes, not the standard. So if you are thinking of buying a template system, know what you are getting into and spend the time to modify them to match your processes.
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 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.