Archive for the ‘Business Process Management’ Category
AS 9100C Is Here, Are You Ready?
The International Aerospace Quality Group (IAQG) released a revision to AS9100, the quality management system for the aviation, space and defense industries. But, unlike the recent release of ISO 9001:2008 (which was more of an amended version), Revision C will have noticeably more impact. Its benefits, however, far outweigh the impact of implementation. The new requirements are intended to make major improvements in quality and reductions in cost – throughout the supply chain.
The Standard includes several new requirements and clauses that focus on planning, project management, and risk management. It is intended to cover on-time delivery performance, the formal monitoring of customer satisfaction trends, and formal plans to ensure continual improvement – all of these new requirements are operation critical. IAQG’s mission is to radically raise the on-time, on-quality delivery (OTOQD) performance across aviation, space and defense industries.
So when should you begin to implement these new requirements? The answer is now. The IAQG has finally completed the training requirements for the registration auditors. Auditors will begin to be trained to AS9100C in May 2010. If your recertification is coming up soon you may want to consider integration of the new requirements now. Keep in mind those suppliers participating in the aviation, space and defense industries will be increasing required to become certified over the next five to ten years. Most, if not all of the primes will require participation from its suppliers and subcontracted service providers. If you want to be a player in these industries, at some point certification will be the only way to play. Are you ready?
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 Is It Just Another Expense?
When I hear a manager say ISO 9001 is just another expense, I immediately know that this organization doesn’t have a clue what ISO 9001 is. Lip service is just that, if you put nothing into your quality management system, you will get exactly nothing in return. ISO 9001 is a quality standard which aims to guide an organization to understand its own business better so that it can meet or exceed its customer needs. By implementing a “successful” quality system the organization will see tangible improvements that lead to reduced costs and increases in market share.
How does this happen, the reduced costs and increased market share? Well if you think just because you plop a system in, you will instantly see the money, think again. This is a process, a process that develops and matures over time which is spurred on by increased awareness and understanding throughout the organization. As you learn more about your internal processes and link them to your customer needs, you will begin to reap the rewords of your efforts.
So get serious about your companies goals and how you will achieve them, (plan) your processes, work your system (Do), (Check) your progress toward achieving your objectives, and make the necessary changes along the way to keep on track (Act). If you are like so many other companies out there, you could use a little help getting started. There are plenty of quality consultants and classes that can do just that. But once you finally “GET IT; your system should become an effortless process that runs like a Swiss watch. This process should not add work or drain resources; rather it should run itself because it is how you do business every day.
Don’t get involved in ISO 9001 with the belief that it is just another expense. Make the process pay for itself by understanding, believing and promoting, and driving your goals and expectations to completion. Lead and you will succeed, or don’t and throw your money and future expectations away. One thing is for sure at the end of the day, if you don’t put your best foot forward, somebody else will.
ISO 9001: Management Review What’s It All About?
Section 5.6 if the ISO 9001:2008 standard requires that top management reviews the organizations quality management system in order to determine its continued suitability, adequacy and effectiveness. There are many ways to satisfy this requirement. Many companies miss interpret this passage to mean they must have a meeting specifically to satisfy this section of the standard. Some companies even go so far as to impose mandatory monthly meeting for this purpose. The standard does not say anything about a meeting, it says you must review the inputs and out puts of your processes at planned intervals.
You must decide how often it is necessary to carry out the review of the required inputs and outputs and how you will review them. You can have several meeting during a given time period during which you address one or more of the requirement at each meeting, (production meetings, customer service sales meetings, quality MRB meetings, annual state of the business meetings, safety meetings, etc). You may decide that top management can satisfy this requirement by individually reviewing the inputs and outputs of the QMS electronically and communicating the results to the organization through action plans to individual departments, group meetings, or supervisor dissemination to the work force. You may decide to go the traditional route and have scheduled management review meetings quarterly or yearly.
The key here is you must decide how and when, and then you must make sure this plan is carried out. When deciding, keep in mind the purpose of this exercise is continual improvement. Don’t invent an elaborate review process that does not add value, make it work for you.
Calibration, What’s Missing from Your System?
Quality management system standards homogeneously have requirements for controlling the devices used to measure, verify, test, and accept product and monitor the processes used to achieve specified results. As a third party auditor it has come to my attention that everyone seems to miss something. It’s almost unavoidable. Perchance it’s because this process is by and large referred to as “calibration” and the rational image it invokes is associated primarily with things like micrometers, depth gages, and comparators. The process is often much more complex, addressing apt consideration for gages, thermostats, software, jigs, timers, known-good-samples – a multiple of devices for measuring product or process. Controlling monitoring and measuring devices must, therefore, include multiple aspects.
Some areas which you should consider when setting up your system should included:
*Identifying which devices need to be calibrated and which do not (you decide based on your quality criteria and your customer requirements).
* Defining the frequencies needed to insure calibration is well controlled
* Indicating the status of equipment; calibrated or out of calibration
* Determining alternate methods of “control”
* Determining what to include in the procedure
* How will you handle certificates of calibration
* Will you use outsourced calibration services and how will you control this if you do
* Defining storage and preservation criteria in your process
* Defining recall programs and contingency plans
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.
ISO 9001 Paper or Software?
When setting up your quality management system it is important to understand your options and their advantages and disadvantages. I have been involved with developing and implementing ISO 9001 and AS 9100 quality management systems both through a manual paper system and an automated software system. Each option has very distinct advantages and disadvantages which can help you determine which way your organization should go.
Option # 1 the paper system. This system is best implemented in a small to mid size organization where control is easily maintained. A paper system can get extremely convoluted in larger companies, which can result in inadequate control and subsequent non-conformances during a third party audit. The key to implementing a successful paper quality management system is to keep it simple and manageable. If your system requires excessive maintenance it will become a burden which may result in the failure of the system to yield the continual improvement objectives that it was set up to achieve.
Option # 2 the software approach. This system is advantages in both small and large companies and offers the added advantage of organization and control for your entire quality management system. By setting up your system digitally you can automatically control revisions and distribution of your documentation. You will also be able to communicate non-conformances, progress towards objectives, internal audits, calibration control, preventive actions, and supplier control and customer satisfaction. Your only real limitation with this system is the level of access your organization is capable of providing. If the rank and file is unable to access the system it does you little good. The best digital systems are internet based SaaS systems which offer access anywhere, anytime to internal and external users such as customers and suppliers.
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.