Archive for April, 2010
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