Posts Tagged ‘quality requirements’
ISO 9001 and Training: What Do I Need to Know?
ISO 9001 is not just satisfying the documentation requirements and your of and running. Training everyone to the standard and their part in the process is key to your success. If everyone in your organization has a working knowledge of the requirements and process of becoming certified, you can begin to develop the roles and responsibilities and the documentation. Once you have identified the roles and responsibilities and have developed the necessary documentation, you need to begin the training to each of the defined processes.
Here is the best part, by developing a robust training program you can reduce the amount of work instructions required to manage your processes. . The amount and extent of an organizations documentation, above and beyond the required documentation called out in the standard, is directly related to the amount and extent of the training an organization provides to its work force. This is not to say that you will not need some work instructions. Some training that you will need to consider while implementing your quality management system:
- ISO 9001 Introduction
- Corrective/Preventive Action
- Root Cause Analysis
- Introduction To Process Mapping
- Documentation Training
- Internal Auditing
- Quality Policy Training
- Job Specific Training
- Management Review Training
A Better Way to Manage Internal Audits and Management Reviews
Many organizations struggle with how to manage and maintain their internal audit and management review processes. While no one sets out to deliberately miss manage these processes, they can take on a life of their own. So, how do you better manage these processes? The ISO 9001 standard does not expressly tell you how, but it does tell you what is expected. Does the standard say you have to actually meet to satisfy this clause of the standard or does it tell you that you have to review the necessary criteria at set interval? If it were possible for top management to review all of the in-puts and out-puts of a management review and assign actions with follow-up, without actually sitting in a meeting, how much more time could be spent on actually improving your systems?
Meeting/audit module in CIS Software is a powerful management action item tool and may be used for many other functions other than just meetings and audits. Because of its design and ability to assign action items to a manager or group of managers and to follow-up on these action items until completion, this module is truly invaluable.
By using the meeting/audit module, there is no need to hold follow-up meetings to review and ensure that previous action items from a meeting or internal audit were completed. Since holding these follow-up meetings is the normal management approach in most organizations, this module alone will cut your valuable meeting time by more than 30 %.
Furthermore, the meeting/audit module includes special tools for Process Auditing. Since the management meetings are all shown on the master calendar and audits may be scheduled monthly, quarterly or yearly, the internal audit plan is always at the click of a mouse. Furthermore, the auditor and auditee is always informed of these audits on their personal calendar and on the master calendar
Follow-Up Of Effectiveness ISO 9001
As a third party auditor we see many common threads where organizations just don’t understand how to implement a particular element of the ISO 9001 standard. For instance, section 8.5.2f corrective action reviewing the effectiveness of the corrective action taken. I have seen this particular requirement missed, more than any other requirement. What does it mean to review the effectiveness of a corrective action? Does it mean complete the action and close it, I done? No, this requirement goes to the heart of continual improvement, because it makes you look at what you have done, and determine if it actually accomplished what you set out to accomplish.
THE TERM CONTINUAL IMPROVEMENT REFERS TO AN ONGOING PROCESS OF PERFORMANCE ENHANCEMENT. CONTINUAL IMPROVEMENTS CAN BE ACHIEVED BY CARRYING OUT INTERNAL AUDITS, PERFORMING MANAGEMENT REVIEWS, ANALYZING DATA, AND IMPLEMENTING CORRECTIVE AND PREVENTIVE ACTIONS.
Corrective action effectiveness should be verified/validated and reviewed by management; if specific actions are not timely and/or effective further or additional action should be assigned. A good practice is to conduct periodic audits of corrective actions to further verify effectiveness of corrective actions. You need to know that what you have done actually worked, and if it didn’t then you need to do something else. The whole purpose for writing a corrective action is to fix something that has caused a problem. If you never go back and look at the affect the change had on your system, how will you know that it worked?
It is so important to make sure all of the individuals involved with your quality management system receive some form of iso 9001 training, so that when the auditor gets to your door, this and other misinterpretations of the standard won’t cause you heartburn.
ISO 9001 Software Solutions For Obsolete Documentation
A common criticism of ISO 9001 is the amount of money, time and paperwork required for registration. Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed. CIS software can reduce the need for a system based on the production of hard copy documentation, therefore reducing the possibilities for nonconformance’s due to obsolete documentation use. A CIS consultant can open up whole new possibilities for an organization struggling with document control, and much more.
If the only documentation available for use is always current and all obsolete documents are stored in a history tab (Unavailable for use), then the auditor will never be able to write another corrective action based on the use of obsolete documents. Wouldn’t that be great! And just think, how much time will that save when you no longer have to hunt down all the obsolete documents in your facility before the auditor arrives. Bliss
ISO 9004 Satisfying Customer Needs
The upcoming revision of ISO 9004 is based on the principle that satisfying customers may bring success, but to sustain success organizations need to delve much more deeply and satisfy the needs and expectations of all interested parties. This attempt suggests applying quality management principles to the quest of sustained success in an organization, but nothing new is added by way of quality management principles. It is implying that sustained success can be accomplished by intelligent use of the eight quality management principles through a system of hands-on managed processes that:
- Continually monitor and analyze the organization’s environment
- Define the needs and expectations of interested parties
- Establish and maintain a mission, a vision and values consistent with the needs and expectations of interested parties
- Deliberately set out, 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 accomplishment 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, continuously.
- Regularly monitor, measure, analyze and review the continual success of the organization
ISO 9004:2009 Self Assessment
ISO 9004:2009 allows organizations to enhance the quality of product and service delivery to their customers by promoting self-assessment as an important tool to enable organizations to:
- Benchmark their level of maturity, covering leadership, strategy, management system, resources, and processes
- Identify their strengths and weaknesses
- Identify opportunities for either improvements or innovation, or both.
The self-assessment tool may become a key element during the strategic planning processes in any organization.
“The objectives of customer satisfaction and product quality are extended in ISO 9004:2009 to include the satisfaction of interested parties and the performance of the organization. The combination of ISO 9001 and ISO 9004 will allow you to get the most of your quality management system.
AS9100 Initial Assessment, What Does It Involve?
The quality certification assessment for AS9100 has two main goals:
- Validating system compliance and implementation
- Determining system effectiveness
Initial assessments are conducted in two stages. The first stage involves determining the company’s state of readiness and defining the approach and duration of the second stage.
Prior to conducting a quality management system AS9100 certification audit, the following should have taken place:
- The documented system has been reviewed and approved
- A complete cycle of internal audits has been performed and the results covered in a formal management review
- You know exactly what SQA will be looking for, so there should be No Surprises
- All identified weaknesses in the system that were discovered in the pre-assessment have been effectively corrected
- The certification assessment date, audit team makeup, and audit schedule have all been developed and agreed upon
What Is The QMS Scope For ISO 9001?
The scope of the QMS should be based on the nature of the organization’s products and their realization processes, the result of risk assessment, commercial considerations, and contractual, statutory and regulatory requirements.
While ISO 9001 is generic and is applicable to all organizations (regardless of their type, size or product category), under certain circumstances, an organization may exclude complying with some specific ISO 9001 requirements (from clause 7), while being permitted to claim conformity to the standard. This is because it has been recognized that not all the requirements in this clause of the standard are relevant to all organizations.
To enable identification of what has been registered/certified, the scope of registration/certification should clearly define:
*the scope of the quality management system (including details of the product lines and related sites, departments, divisions etc. that are covered by it)
*the organization’s main processes for its product realisation or service delivery activities (such as design, manufacture and delivery), for the product lines that are covered
*any ISO 9001 requirement that has been excluded
ISO 9001: Verification of Effectiveness?
What exactly is verification of effectiveness? Many organizations struggle with this quality management requirement. When you are verifying the effectiveness of a corrective action you are seeking evidence that the causes of the problem have been removed or reduced. In a perfect world, each problem cause would be removed. This however is not always possible. Sometimes the best you can hope for is a reduction of the causes. The cause is still there, but it manifests itself less frequently or less severely. So the best option is to remove the cause, but the next best option is to at least reduce the cause.
The key to verification of effectiveness is evidence. You are seeking objective, factual evidence that your problem causes have been reduced or removed. This evidence usually takes the form of data or records. Another powerful form of evidence is your own first-hand observations. That’s not to say that you can’t accept verbal evidence, but records, data, and first-hand observations are certainly better and more easily audited. To improve your current corrective action process make sure that each time you act to correct a non-conformance, you go back and verify that what you did actually accomplished what you set out to do, “ remove or reduce the problem”. Some software applications available today can greatly aid an organization that is struggling with this requirement by prompting the responsible individual to review the corrective action taken so that a decision can be made as to the effectiveness of that action. Let’s face it, today small business owners are concerned about where each dollar is being spent and what the pay back will be. Software is one of the best ways to add value when organizations are continuing to down size.
ISO 9001 Calibration Considerations
Quality management system standards uniformly have requirements for controlling the devices used to measure, verify, test, and accept product and monitor the processes used to achieve specified results. Everyone seems to miss something. It’s almost inevitable. Perhaps it’s because this process is generally referred to as “calibration” and the mental image it conjures up is associated primarily with things like micrometers, depth gages, and comparators. The process is often much more elaborate, addressing appropriate 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 factors.
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. If results from monitoring and measuring devices are fed into a computer and the program mathematically processes the results to provide an end result (for example using Microsoft Excel), the program should be “validated”. Typically, validation is done by comparing the results of the program with the results calculated manually. If the results do not match then it implies a fault in the software program (assuming the manual calculation is correct). Software validation should be carried out before the system is put into use. If the calculation algorithm of the program is modified then the validation exercise should be repeated.