Archive for the ‘AS 9100 Certification’ Category
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
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?
If AS9100:2009 is published, why can’t I get certified to AS9100C now?
Before any company can be certified to the AS9100C standard, the aerospace industry must complete these milestones:
- The AS9104-1 standard must be published (expected spring 2010)
- The AS9101D standard (checklist) must be published (expected Spring 2010)
- The AS9100C/AS9101D course for certification body auditors (NQA auditors) must be developed, vetted and made available for use by certification bodies (expected by 30 April 2010)
- Certification body auditors must attend this course, pass it, submit their applications to RABQSA and get approved (we expect that to happen over the summer and fall of 2010)
- The registrars must submit an application to ANAB and then be audited before we can be accredited to perform audits to AS9100C (we expect that to happen early summer of 2010)
Once all of the above tasks are completed, registrars will be able to conduct audits to the quality management system requirements of AS9100 revision C.
As to when your company must transition to this new standard, all AS9100 audits after July 1st, 2011 must be to AS9100C and that by July 1st, 2012, AS9100B will cease to exist and all registrations for AS9100 must be to revision C of the standard.
The Templated Quality System: Mistakes Made
Time and time again I walk into an organization to audit their quality management system and I find that the overall processes and controls are well understood and executed, but the documentation just doesn’t match actual practices. Templates are great tools to help an organization meet the documentation requirements of ISO 9001, AS9100, or any standard. The problem is, most companies buy the templates and insert the name but never modify the templates to their particular processes. The results from such miss use of this tool are non-conformances found during a surveillance or registration audit.
Templates can help save time and help an organization cover all of the requirements of the standard, but they can hurt and organization if they are not used properly. Plan your processes and understand the standard that you have chosen to become certified to. Knowing what is required and what is not can help you to modify the templates to reflect your organizations actual practices. Most non-conformances, about 90% to be exact, are written against what the organization has required of itself or documentation that does not match the processes, not the standard. So if you are thinking of buying a template system, know what you are getting into and spend the time to modify them to match your processes.
Suppliers: Positive & Negative Affects
Suppliers are an integral part of any organization’s overall process. As such, they have the potential to be a positive or negative force. When suppliers are a positive force, materials arrive on time, materials are processed in a problem-free manner and costs are controlled. When suppliers are a negative force, materials often arrive late, processing problems occurs, and the supplier is of little or no help in resolving such issues. Obviously, it just makes good sense to have good suppliers.
The industry is quickly moving toward requiring their subcontractors and suppliers to be AS9100 compliant and/or certified. By conforming to AS9100 or becoming registered by a third party, suppliers can gain a competitive advantage and benefit from the improved processes and continuous improvement that is the foundation of ISO 9001:2008 certified quality management systems.
General Electric Aircraft Engines (GEAE) was one of the first manufacturers to require AS9000 compliance by all of their direct material suppliers. Currently, GEAE is requiring as9100 certification for all new suppliers, and existing suppliers have a gap audit and a certification audit performed to coincide with their existing surveillance audit schedule.
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
Benefits of ISO 9001 Certification
If you are unfamiliar with ISO 9000 standards for quality management, you may be wondering why it benefits your business to meet these standards. ISO standards are designed to ensure that your employees are working to their full potential and that your clients are satisfied. Reforming your business to qualify for ISO 9001 certification will garner both internal and external benefits.
Some of the basic requirements for certification include implementing a set of procedures to cover the basic processes of your business, as well as having a system for checking these procedures. You will also be held accountable for maintaining accurate records and performing continuous reviews of your employees and business practices.
Guidance for the Use Of Configuration Management
ISO 10007:2003 gives guidance on the use of configuration management within an organization. It is applicable to the support of products from concept to disposal.
It first outlines the responsibilities and authorities before describing the configuration management process that includes configuration management planning, configuration identification, change control, configuration status accounting and configuration audit.
Since ISO 10007:2003 is a guidance document, it is not intended to be used for certification/registration purposes.
This is a great tool when tackling the concept of configuration management, a lot of emphasis is placed on this process in the AS9100 certification standard. Using this document along with the assistance of a business management consultant, can reduce the time it may take to plan and implement this process.
Quality Management Software
With the size and complexity of some supply chains, it is no wonder that organizations struggle with how to implement and control this process. Many small business owners have been asked to provide proof of this control by their customers. The question is, how?
If you are struggling with how to manage your supplier management program there are now software applications that can assist you with this task. For example, CIS Software can eliminate the time and money of issuing Supplier Report cards or Performance Reviews. Watch this YouTube video for some great information on how to better manage this process. CIS Software