Posts Tagged ‘business process improvement’
ISO 9001: Where applicable, provide training or take other actions to achieve the necessary competence (Section 6.2.2 b and c)
It is up to the organization to determine the appropriate method to satisfy this quality management system requirement. This can be in the form of on-the-job, job shadowing, mentoring, public seminars, educational courses or any other suitable method.
Follow-up to ensure the competency was effective
Following the training, a suitable evaluation of the employee’s competency level should be completed. The standard requires the organization to:
Evaluate the effectiveness of the actions taken (ref. 6.2.2 c)
Again, the organization must determine the method that works best for their particular needs, ISO 9001 does not specify the how, just the what of the requirement. Verification of effectiveness could be as simple as repeating the competency rating process to ensure the gap has been closed. Other approaches might include:
- Special inspection of the employee’s work until the needed quality level is reached
- Written test following the training
- Formal certification process
- Supervisor follow-up 60 days (or so) following the training or intervention
- Formal performance review
Quality Management Systems Software Advantage
With all of the software packages out there today, it is hard to believe that there are any companies who still design their quality systems on paper. I grew up on the manual paper version of a quality management system, back when there was a whole department dedicated to document control and everyone had a three ring binder full of documented procedures on their desk. So here we are today with ISO 9001:2008, AS 9100 C and various other international standards which do not require reams of paper to be compliant. When a company decides to implement a new quality management system, I don’t believe anyone sets out to create the quality system from hell, but all too often that is exactly what happens.
Why put yourself through all of that pain and unnecessary cost? There are so many software solutions available today that make getting and maintaining your certification effortless. As a management representative for a small company in Arizona, I was able to manage the quality system and carry out the responsibilities of a supply chain manager without adding one more person to the company for the sake of our quality system. How you may ask is this possible? The answer is a fully customizable software application that put all of our processes and documentation in one place. This software is SaaS based and therefore it is accessible from anywhere internet access is provided. All of our employees, key customers and suppliers were able to view and make entries as need and management decisions where determined through the analysis of the data collected by the system. What was most impressive about the implementation process was how easy it was to train everyone to use the system.
As I said before there are literally thousands of software applications for quality management system implementation. The range of products goes from supper high upfront and maintenance costs, to low upfront and maintenance costs. Complicated canned systems with little customization possibilities to easy fully customizable systems are also available. If your company is use to complicated and costly to believe you are getting a good product, then that’s the road for you. If on the other hand you are a small to midsize company with limited resources, (People and Finances), you may be interested in the latter. Do your research well and you can find a system that will work for you and actually deliver a cost savings benefit. Some items to consider:
Costs
- Upfront Cost
- Monthly Support Costs: or
- Yearly Support Costs:
- Does your system include Unlimited Users and Storage and support and revisions and new features.
- Education & Safety Costs
- Cost for Additional Modules
Applications
- Communication System
- Document Management
- Reports and Graphs
- Master Calendar
- Work Orders
- User Preferences
- Nonconformance
- Corrective Action
- Customer Feedback
- Preventive Action
- Near Miss
- Customer Supplied Product
- Inspection
- Management Review
- Internal Audits
- Calibration Control
- Quality Objectives
- Supplier Approval and Evaluation
- Competency, Training and Awareness
- Purchasing
- Job Management
- Special requirements
Quality Management Systems Auditing, Make It Worth Your Time
With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the quality management system or the total process, and the results that have been achieved through the implementation of a QMS. And now with the upgrades of the AS9100 quality standard, there are even more ways to develop and implement corrective and preventive actions that will greatly benefit the organization.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for assessing the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. By highlighting these areas other departments may share information and amend their working practices as a result, which contributes to continual improvement.
There are times that auditing feels like an arduous ordeal, and those being auditee feel as though they are being personally judged. The most important part of conducting an audit is to communicate with the auditee the intent of the audit and their role in it. For an audit to give meaningful information back to the organization, you must get the cooperation of those being audited. Let them know that the audit is not a tool to punish but rather an opportunity to improve the organization as a whole. Finds are not bad things, quite the contrary they are the building blocks for the continued success of the organization (continual improvement). Why not make it the responsibility of each employee to contribute at least one opportunity for improvement each year. Just think how much better your company will be after one year.
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: 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.
ISO 9001 Helping Select and Manage Your Suppliers?
When you purchase products or services from a supplier, you have two primary considerations:
1. Will the supplier you eventually select provide the best overall value or service which is consistent with your requirements?
2. Does the supplier have the ability to consistently provide the quality desired?
For consideration one – as the customer, you must specify criteria and quality objectives for the product. Through the use of your own quality management systems, you then confirm that delivered product meets your specifications.
For the second consideration – you may want the supplier to have a quality management system of their own to insure consistent controls are in place. How much control? To answer this, you need to consider the following questions:
· What (goods or services) will you be purchasing?
· What significant impact could these products have on the products you make and sell to your customers?
· What are the risks to your business if you experience a major upset as a result of a product non-conformance caused by these products?
· What do you know about the character and past performance of your supplier?
ISO 9001:2008 provides requirements for the purchasing process that your organization can implement, to develop and improve relationships with suppliers. These requirements include:
· Establishment of criteria and quality objectives for products or services you expect to purchase
· And quality management system controls that you require your suppliers to develop to meet your organizational requirements.
Supplier surveillance audits are very advantages when working with a supplier who’s product could have an major impact on your continued success. By periodically auditing these suppliers to your requirements, you will be ensuring that their quality management system continues to meet the needs of your organization. Even with the best of relationships, changes can occur that may cause unforeseen catastrophic results. Keeping your supplier close and monitoring their quality system will strengthen the relationship and reduce the chances of a major upset.
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?
Your Internal Auditing Process, Does It Hurt Or Help Continuous Improvement?
A Quality audit is the process of organized inspection of a quality management system carried out by an internal or external quality auditor or an audit team. It is an important part of organization’s quality management system and is a key element in the ISO quality system standard, ISO 9001.
Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly-defined internal quality monitoring procedures linked to effective corrective and preventive actions. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria.
With the upgrade of the ISO9000 series of standards from the 1994 to 2008 series, the focus of the audits has shifted from purely procedural adherence towards a process approach of the actual effectiveness of the Quality Management System and the results that have been achieved through the implementation of a QMS.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined objectives, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organization, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement.
Internal audits should always be performed with the intension of improving the overall systems being audited, never as a fault finding or witch hunt practice designed to punish. If internal audits are properly executed with a spirit of open communication and real process improvement, this process can be the single most important driver for continual improvement. Done wrong, the internal quality audit processes can create a culture of fear which will hinder continual improvement. It is important that everyone within the organization clearly understands the objectives of quality auditing and their role in them.
Does Your Corrective Action Process Really Work?
When a deficiency in your quality management system is discovered, is it documented and thought of as a good thing? One of the most common problems I have encountered as a third party auditor and consultant is the fear of Nonconformance’s. During initial presentations to a company, particularly if I have senior management in the room, I will ask about their corrective action process, how it’s working for them and how many nonconformance’s they document in an average month. A typical answer is a very proud indication that they have a great corrective action system and they generate very few nonconformances. That is a self-contradicting statement.
Chances are very good that nonconformances are seen as a bad thing in these companies and the person responsible for this horrible offense is hunted down and profusely reprimanded for such callous offenses. Does this sound familiar?
Let me set those who still feel that nonconformance’s are bad, THEIR NOT! If you find 3 things going wrong within your organization this week, and resolve them so they never happen again, do you think you have improved your company’s performance? Hello McFly, guess what the bonus is – there’s a pretty good chance you will improve your bottom line as well! So get out there and find as many nonconformances as you can. You have nothing to lose and everything to gain. Remember, the whole idea is to continually improve your products and processes so that you can compete and grow.