Posts Tagged ‘continuous improvement’
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?
Steps to Effective Corrective Action
Most organizations do not take the time to really determine effective corrective action. The knee jerk reaction to a non-conformance is to fix the symptom. When we take the short cut to correct a significant non-conformance we ultimately doom ourselves to repeat the same mistakes over and over again, until we actually correct the root cause. How do you go about getting to the real cause (root cause) of a non-conformance? There are several steps that can help determine “why” something went wrong. Using these steps will simply the corrective action resolution process and add real value to your quality management system.
- Identify the non-conformance and document it (Describe what went wrong).
- Take immediate action to contain the problem (This is containment not the ultimate corrective action).
- Determine the root cause for the discrepancy (Why did this happen). Don’t jump to conclusions at this step. Take the time to ask pointed “Why” questions, and answer them until you get to the ultimate cause. Most organizations never get to the real cause because they are in a hurry to close the action out and move on. Take your time, think it through; the answer you should almost never come to should be human error. If someone makes a mistake the next question should be “why” did they make this mistake? Don’t put a Band-Aid on the problem; fix it or I grantee it will come back.
- Now that you have determined the real cause you will need to but a corrective action in place to resolve, (prevent), the problem from reoccurring in the future. Implement the action and close the corrective action out.
- Last, and very important, you need to go back at a later date after you have implemented the corrective action and verify that the action actually had the effect you intended. If the action was effective you have successfully completed the corrective action process and have implemented a meaningful resolution to a problem. If the action did not resolve the issue you will need to go back and start the process all over again until you come up with an action that does effectively eliminate the issue.
Corrective and preventive actions are the backbone of your continuous improvement process, done right you can make significant improvements to your organization.
Getting The Most Out Of Your Quality Objectives
ISO 9001:2008 mentions quality objectives at least 14 times. Basically, quality objectives allow us to measure our progress and make improvements. How else can we conclude if we’re doing the right things and what we should do next? Without metrics you have no way of knowing if there has been a return on investment for an improvement initiative, capital expenditure, or new product design.
Objectives are the essential links between day-to-day activities and strategic planning. They make it possible for individuals throughout the organization to monitor processes and communicate performance to the decision makers. When we develop our strategic objectives (the ones that will move us to the next level of quality or profitability), what should we be looking at and how should we be looking at it.
The standards for ISO 9001 and AS9100 require that objectives be set and implemented to promote continuous improvement. If you were to set objectives that had no measureable metric and no time line for completing, how would you ever know if you had completed them or if they made any difference at all?
As a third party auditor, I have seen many failed attempts at setting meaningful objectives. The primary reason for these failures is lack of understanding of what should be included when setting these goals.
A good rule of thumb is to always include the following information in each objective:
- A starting point-Where are we now?
- A desired result-where do we want to be and what do we want to accomplish?
- When do we expect to complete this objective-Put a stake in the ground.
Example:
“We will improve our delivery performance to our customers from 85% to 95% by December 2010.”
Once you have set your objective now you must show progress toward completion-measure and report. Make decisions and take action to keep moving in the right direction. If you miss your deadline, don’t worry, you can always push your time-line out. The primary reason for objectives is to keep moving toward improving your quality management system and better satisfying your customers. Competition is steep in today’s economy; keeping ahead of the competition requires planning and measuring on a regular basis. Make your objectives count; they can be the difference between success and failure.
ISO 9001 Internal Auditing What, When, How?
Most companies understand the idea of auditing but not the concept of “Process Auditing” as expected to be compliant within both ISO 9001 and their own quality management system. Even companies that are currently registered to the standard may not have a thorough means for evaluating its processes through their internal audit program. Which processes are expected to be audited under ISO 9001?
The ISO 9001:2008 standard is quite vague as to what should to be audited or even how often these processes should be reviewed. The standard indicates that audits be carried out at planned intervals to determine whether the quality management system conforms to the planned arrangements, to the requirements of the standard and the organizations own quality management system requirements. So what is an appropriate interval for your company? Ask yourself,” What is the worst that can happen and where could it happen”? Where are we having the most problems now? Look at your interrelationship of processes and pinpoint the likely areas that have the most chance of resulting in non-conformance. Conduct a risk assessment to determine where the highest risks are, and which risks may produce the most significant impact on your product performance (Status and importance of the processes). Now audit these processes, interview staff, observe activities and view relevant records then determine if there are weaknesses and assign corrective actions. Go back to these areas after the corrective actions are put in place and determine if the actions have accomplished the desired effect. If the actions are effective, close out the audit and move on to the next process.
Don’t audit a process for the sake of having an audit record to show an auditor. If a process is functioning properly it does not need to be audited once a year. Nowhere in the ISO 9001 standard does it say you have to audit all of your processes once a year. You are in the driver seat, and you will determine what, when, and how you will audit your system.
ISO 9001 Internal Auditing Success
The third party auditor will audit your system once or twice a year, so why do you have to conduct internal audits? The first and most obvious reason is, if you wait for the third party auditor to tell you your system is in trouble, you are missing the point of continuous improvement all together. The second reason is that the third party registrar does not consider the surveillance audit as an internal audit. The standard requires that “you” perform planned internal audits of your system based on status and importance of the processes and areas to be audited. If you do not know whether or not your quality management system conforms to your planned arrangements, or the standard, then how can you determine if you are improving? The ISO 9001 standard is based on the Plan, Do, Check, Act principle of continuous improvement. Internal Auditing is the “Check”, and without it you may never know when to act.
The internal audit process need not be a time consuming; there are many ways an internal audit can be accomplished. Every day we conduct countless audits without even knowing it. A manager who walks the plant floor may notice a process which is not working as intended, a worker may notice that the forms he, or she is using are outdated , receiving may find that the same supplier never send the correct paperwork with the products they provide; these are audits that never get documented. These audits are not planned, but they are audits none the less. The planned audits do not have to include all of the processes in your facility once a year, remember “Status and importance”. Go after the low hanging fruit first, (areas where you are having issues), then review the other areas as needed. Whatever you do, DO SOMETHING, or your entire quality system will fail to accomplish the goals and objectives you have set for your organization. My philosophy is simple, if you are going to invest the time and money to become certified, get the full value of certification or you will be wasting your resources for nothing.
Supply Chain Surveillance (Auditing Your Suppliers For Sustained Success)
Supplier auditing or supply chain surveillance is most effective and worthwhile for both organizations when approached through a shared partnership style. Traditional audits that “uncover” problems, inconsistencies and non-compliances then issuing corrective actions and/or penalties are costly, ineffective and outdated. The most effective surveillance systems will contain many business and quality management assessment elements including:
• Design management
• Reduced lead time initiatives
• Supply chain key measurable such as:
- Product and service delivery
- Product and service quality
- Corrective and preventive action reporting and resolution
• Financial strength
• Continuous Improvement
• Supplier chain management
• Price reduction initiatives
• Value-added project management
The goals of the surveillance process are to keep both organizations focused on sustained success, review additional opportunities and build the relationship. When done well, there should be no bombshells going off which could affect the overall success of both business entities. When the relationship adds value to both companies, then it should be developed. If this is not the case, and there remains adequate trust between the business partners, corrective actions can be made, or a beneficial exit plan devised. Business relationships are ever changing; as the business climate changes, supply chain relationships also will change. Supplier surveillance is an effective approach to managing these changes before they become problems.
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?
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
Seven Steps To Implentation of ISO 9001
For a successful implementation of your Quality Management System, the following seven steps are recommended:
- Fully engage top management – Determine and define why you want to implement ISO 9001, Determine and define your mission, vision, and values in your organization , Define your organization’s stakeholders : customers, suppliers, stockholders, employees, society, etc., Define your quality policy, and , Define and align organizational objectives and related product/service quality objectives.
- Identify key processes and the interactions needed to meet quality objectives
- Implement and manage the QMS and its processes (using process management techniques
- Build ISO 9001-based QMS-Identify ISO 9001 requirements, Map these requirements with your implemented QMS, where applicable, Make a gap analysis : identify where in your existing system the requirements are fulfilled, and where they are not, Include in your QMS processes the activities, procedures and controls needed.
- Implement the system, train company staff and verify effective operation of your processes
- Manage your QMS- Focus on customer satisfaction, Monitor and measure the operation of your QMS, Strive for continual improvement, Consider implementing business excellence models in the company operations.
- If necessary, seek third party certification/registration of the QMS or alternatively, issue a self-declaration of conformity