Posts Tagged ‘quality requirements’
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
AS9100 C Just Around the Corner, What’s New?
The increased requirements of AS9100, which builds on ISO 9001:2008 elements, will benefit both defense and non-defense customers since the standard focuses on critical areas important to all industries such as supply chain management and process control.
Much has happened in the last year relative to aerospace industry quality management system standards. It was with some anticipation that the latest revision of AS9100, Quality Management Systems—Requirements for Aviation Space and Defense Industries was released.
This latest edition of the standard was a two-fold revision by the International Aerospace Quality Group (IAQG). Not only was it revised to correspond to the root document, ISO 9001:2008, but it was also a significant update to the aerospace requirements of organizations that manufacture and supply products to the aviation, space and defense industries.
This revision of the standard was broadened to be more inclusive of all aspects of the customers and users of the products that concern the IAQG. It is also more detailed to ensure supply chain requirements for registering organizations are aligned with current industry practices.
A summary of some significant changes:
- 7.1.1 Project Management
New requirement for planning and managing product realization in a structured and controlled way. - 7.1.2 Risk Management
New requirement of implementation of a risk management process applicable to the projects & products; responsibility, criteria, mitigation & acceptance. - 7.1.3 Configuration Management
Moved from clause 4.3 to clause 7.1 and added details on the different activities to be covered. - 7.1.4 Control of Work Transfer
Moved from clause 7.5 (Production) to clause 7.1 to add emphasis on having a process for planning and control of transfer activities. - 5.2/8.2.1 Customer Focus/Satisfaction; Formal monitoring of Customer satisfaction data. Added the requirement to monitor data and to develop improvement plans that address deficiencies. The intent is to promote continuous improvement of the product and Customer satisfaction.
- First Article Inspection (FAI) moved to clause 7.5.1.1 and renamed.
Production process verification “FAI” is the requirement to validate the production process’s documentation and tooling and repeat the process when necessary (i.e. when engineering or manufacturing processes change). The requirement was moved from 8.2.4.2 (measurement) to 7.5.1.1 (production) because it is part of product realization and is not intended to be a follow-on activity. - ISO 9001 changes affect AS9100:2009.
The AS9100 standard has been updated to stay consistent with ISO 9001, which will continue to be the baseline. The changes being incorporated into ISO 9001 are considered an amendment and minor in nature.
AS9100 Revision “C” Key Changes
• 6 Additions
• 8 Revisions/Relocations
• 3 Deletions
What Are The Inputs and Outputs and Key Measurables Of A Process?
With ever business process that you put in place there are inherent inputs, outputs and key measurable that will help you determine whether or not you are meeting the objectives of the process. You will first need to determine the inputs of your processes, “What are the key aspects of the process that you would like to achieve?” For instance, in your supplier management process what will be your objective? Your objective should be to have approved suppliers. Now, what will you put in place to achieve your objective: Supplier approval criteria, Supplier Evaluation (inspection discrepancies) and Supplier Reevaluation. These will become the inputs to your supplier management process.
Once you have determined the inputs of your process you will next need to determine the outputs of the process. In the example noted above some possible outputs to the supplier management process would be an Approved Supplier Register, and Receiving Discrepancies. These will become the evidence of your approval process objectives.
Once you have determined the inputs and outputs of your process, you must now measure the process to see if it is accomplishing its intended purpose (Approved Suppliers based on the inputs and outputs you have set in place). Key measurable for a supplier management process may include Supplier Performance data reviewed in Management Review (Receiving Inspections), Evidence of the organizations certification to an international standard (A copy of a current ISO 9001 or AS9100 certificate), results from a supplier audit or survey , etc. You must determine how you will measure a supplier’s performance towards your requirements and then keep records to verify their effectiveness at meeting these requirements.
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 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.