Posts Tagged ‘business management system’
ISO 9001: Determine the necessary competence for personnel performing work affecting conformity to product requirements (Section 6.2.2 a)
There are two excellent reasons to train employees to your quality management system and your processes:
• Every employee can have potential impacts on the QMS; and
• It is a requirement of ISO 9001:2008 and virtually any well functioning quality system
Each person and function within your facility plays a critical role in the quality management system. For this reason, your training program should cast a wide net. Every employee and manager should be aware of the quality policy; the significant impacts of their work activities, key quality roles and responsibilities, procedures that apply to their work, and the importance of conformance with ISO 9001 requirements. Employees should understand the potential consequences of not following the requirements of the QMS (such as poor product performance, reduced customer satisfaction, and loss of business).
All personnel should receive appropriate training and support to be competent at their work.
Training should be tailored to the different needs of various levels or functions in the facility. However, training is just one element of establishing competence, which is typically based on a combination of education, training, and experience. You should establish criteria to measure the competence of individuals performing tasks that can impact on the quality of your products.
Training is needed both in technical work and for general awareness on the part of all employees
To define requirements for each job position questions to ask:
- “What job-specific knowledge area(s) must be well understood by someone in this job?”
- “What manual, mental or interpersonal skills must an employee have to do this job well?”
- “What natural abilities or talents must someone possess to be effective in this job?”
The result from this exercise is a list of competencies for the job that can be used for hiring purposes and subsequent training and development plans. Once the list is prioritized to include only the most critical competencies, you will need to document them in some appropriate manner (job descriptions, training matrix, or other means).
ISO 9001/AS9100 Who Owns Your System?
ISO 9001:2008 requires top management to actively participate in their organization’s quality management system by developing and implementing quality objectives and periodically evaluating the health of the system. This concept may seam foreign to some top managers, as some organizations still subscribe to the notion that the management of their quality system belong to the quality manager. As a lead quality management systems auditor I have seen this time and time again, often with bad news for those at the top. Without the ongoing participation and commitment from top management, it is virtually impossible to maintain a quality system that consistently meets the ISO 9001 standard or any other standard for that matter.
Top management must be involved at all stages of the quality system, from planning to implementation and ongoing maintenance. Some key areas where management should be involved are as follows:
- Setting Quality policies, planning, and objectives
- Appointing a Management representative and giving them the authority to fulfill their job responsibilities.
- Conducting Management Reviews that involve all of the required inputs and outputs of the QMS and making decisions that will promote continuous improvement.
- Enlisting and Utilizing customer feedback to meet customer satisfaction requirements
- Being visibly involved so that employees know that this is a business management system that is being driven from the top down.
What is most important is that “everyone” is involved with your quality management system, and realizing that no one person in the organization owns it, “everyone” owns it. Everyone must do their part, or as sure as I’m sitting here, the quality system will never deliver the results that is expected. When I hear someone say that ISO 9001 is just another expense, (No Benefit), to be endured for the sake of the customer, I know that these companies do not understand the overall commitment, (Involvement), required to receive any benefit. What type of company do you work for?
ISO 9001/AS9100, Why Do I Have To Conduct A Management Review?
Just as a person should have periodic physical exams, your QMS must be reviewed periodically to stay “healthy.” Management reviews are critical to continual improvement and ensure that the quality management system will continue to meet your facility’s needs over time.
The ISO 9001 standard states, the purpose of a management review is to review the Quality Management System to ensure its continuing adequacy, suitability and effectiveness. This should include an evaluation of the performance of the system based on existing data (review inputs), and should also address any decisions or actions necessary to improve the management system and its related processes (review outputs).
To make your reviews meaningful, such reviews should be performed at least annually, although they may be performed on a more frequent basis, including quarterly or even monthly. The frequency of these reviews is your choice, but I personally recommend that organizations with “newer” systems perform this function on a more frequent basis, at least for the first 18-24 months.
Records of these reviews should be maintained in accordance with your documented control of record procedures. These records should include, the date of the review, participants in the review, criteria by which the system is measured, (Inputs), strengths and weaknesses of the system, and any decisions or actions that are required (Outputs). Such inputs should include, but are not limited to the following:
- Results of Internal Audits
- Customer feedback, both positive and negative
- Process performance and product conformity
- Status of corrective and preventive actions (Are they closed and are the actions taken effective)
- Follow-up of actions from previous management reviews (Are actions being completed?)
- Any changes that could affect the quality system (Personnel, facility, regulations, business direction etc.)
- Recommendations for improvement
Outputs from this review should include and decisions or actions related to the following:
- Improvement of the effectiveness of the QMS and its processes
- Improvement related to customer requirements
- Resource needs to support the QMS.
ISO 9001 Lesson Learned
ISO 9001:2008 is the foundation of many of the quality management standards now available to organizations worldwide to help organize and maintain product and service integrity. The standard in and of itself, does not tell you “HOW “ to do anything but rather it tells you what quality programs and processes you need to establish to meet the requirements of the standard. For example: The standard has numerous passages which state the organization “SHALL” develop and implement something to comply with the standard. The organization “SHALL”:
- determine the processes needed for the quality management system and their application throughout the organization.
- determine the sequence and interaction of these processes.
- determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
The quality management system documentation “SHALL” include:
- documented statements of a quality policy and quality objectives
- a quality manual
- documented procedures and records required by this International Standard
- documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
As you can see, nowhere in these requirements does the standard tell you exactly how to carry this out. Where many companies fall short when trying to interpret the actual intent of these requirements, is the planning process. How much documentation is enough and how will we satisfy these requirements so that what we say we do is actually what we do. A lot of the confusion comes from not understanding the standard, and then ultimately doing too much or too little. Most of the non-conformances that the third party auditor will eventually find, (90%), are written against the self imposed requirements of an organization, not against the standard itself. For example: Some companies buy document templates and insert their name here and there, but never modify the documents to meet their individual process needs. Every company is different, so you cannot buy a caned quality system without modifying it to your particular needs.
Get educated to the standard and or hire a business management consultant that can guide you through the process. ISO 9001 as well as most of the other standards out there does not have to complicated or overly time consuming. Get the most out of your system, and avoid the pit falls generated by lack of understanding.
ISO 9001 True or False?
Everyone has their interpretation of the ISO 9001 standard. Let’s discuss some common misunderstandings, some of these myths, urban legends or perceptions of different requirements that may still exist:
Myth: Implementing and maintaining ISO 9001 is expensive.
- False: it does not have to be expensive. A company simply needs to document its management system based on what it already does and put in place the programs required to improve on them.
Urban Legend: 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 (for example, internal audit coordinator, corrective action coordinator, ISO coordinator).
- False: the ISO 9001 system covers an entire business, starting with customer requirements, review and acceptance of those requirements, executing those requirements, measuring and monitoring processes to ensure requirements are being met and then, ultimately, delivery of a product or service that meets those requirements to ensure customer satisfaction.
Perception: a quality manual has to plagiarize the ISO 9001 standard.
- False: the ISO 9001 standard states, “The organization shall establish and maintain a quality manual that includes:
- The scope of the quality management system, including details of and justification for any exclusions,
- The documented procedures established for the quality management system, or reference to them, and
- A description of the interaction between the processes of the quality management system.”
Perception: it is mandatory to have a document—for example, work instruction, flow chart, procedure—for every process in the company.
- False: ISO 9001 states, “NOTE 2 of the standard, the extent of the documentation can differ from one organization to another due to the size of organization and type of activities, the complexity of processes and their interactions, and the competence of personnel.”
This is just a short list of reasons why organizations struggle with ISO 9001 implementation. Do you have some of these myths, urban legends, misconceptions in your organization?
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.
The Internal Audit and Follow-up for Effectiveness
O.K. now that you have defined your internal auditing process, and have a few audits under your belt, what have you learned that will actually help you improve your organization? Corrective and preventive actions have been assigned, responses have been logged, and actions have taken placed. Did the actions taken, improve the process? This is probably the biggest stumbling block I have seen as a third party auditor, follow-up for effectiveness. Did anyone review the effectiveness of the corrective or preventive action; did it accomplish what you intended? If you do not go back and review the results of the actions taken, you have missed the boat on continual improvement. To merely find areas for improvement without making sure that they have been addressed and actual improvements have been made, is never going to move your company closer to sustained success.
Your business management system can be the best possible way to propel your organization to a new level of profitability and success, use it effectively! Make your quality management processes work for you and you will realize actual benefits that will lower costs, improve cycle times, reduce scrap, and improve customer satisfaction. You can skate by with your paper certificate, but wouldn’t you rather get something for your money?
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.
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.
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!