Posts Tagged ‘AS9100’
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/AS9100 Who Owns Your System?
ISO 9001:2008 requires top management to actively participate in their organization’s quality management system by developing and implementing quality objectives and periodically evaluating the health of the system. This concept may seam foreign to some top managers, as some organizations still subscribe to the notion that the management of their quality system belong to the quality manager. As a lead quality management systems auditor I have seen this time and time again, often with bad news for those at the top. Without the ongoing participation and commitment from top management, it is virtually impossible to maintain a quality system that consistently meets the ISO 9001 standard or any other standard for that matter.
Top management must be involved at all stages of the quality system, from planning to implementation and ongoing maintenance. Some key areas where management should be involved are as follows:
- Setting Quality policies, planning, and objectives
- Appointing a Management representative and giving them the authority to fulfill their job responsibilities.
- Conducting Management Reviews that involve all of the required inputs and outputs of the QMS and making decisions that will promote continuous improvement.
- Enlisting and Utilizing customer feedback to meet customer satisfaction requirements
- Being visibly involved so that employees know that this is a business management system that is being driven from the top down.
What is most important is that “everyone” is involved with your quality management system, and realizing that no one person in the organization owns it, “everyone” owns it. Everyone must do their part, or as sure as I’m sitting here, the quality system will never deliver the results that is expected. When I hear someone say that ISO 9001 is just another expense, (No Benefit), to be endured for the sake of the customer, I know that these companies do not understand the overall commitment, (Involvement), required to receive any benefit. What type of company do you work for?
ISO 9001/AS9100, Why Do I Have To Conduct A Management Review?
Just as a person should have periodic physical exams, your QMS must be reviewed periodically to stay “healthy.” Management reviews are critical to continual improvement and ensure that the quality management system will continue to meet your facility’s needs over time.
The ISO 9001 standard states, the purpose of a management review is to review the Quality Management System to ensure its continuing adequacy, suitability and effectiveness. This should include an evaluation of the performance of the system based on existing data (review inputs), and should also address any decisions or actions necessary to improve the management system and its related processes (review outputs).
To make your reviews meaningful, such reviews should be performed at least annually, although they may be performed on a more frequent basis, including quarterly or even monthly. The frequency of these reviews is your choice, but I personally recommend that organizations with “newer” systems perform this function on a more frequent basis, at least for the first 18-24 months.
Records of these reviews should be maintained in accordance with your documented control of record procedures. These records should include, the date of the review, participants in the review, criteria by which the system is measured, (Inputs), strengths and weaknesses of the system, and any decisions or actions that are required (Outputs). Such inputs should include, but are not limited to the following:
- Results of Internal Audits
- Customer feedback, both positive and negative
- Process performance and product conformity
- Status of corrective and preventive actions (Are they closed and are the actions taken effective)
- Follow-up of actions from previous management reviews (Are actions being completed?)
- Any changes that could affect the quality system (Personnel, facility, regulations, business direction etc.)
- Recommendations for improvement
Outputs from this review should include and decisions or actions related to the following:
- Improvement of the effectiveness of the QMS and its processes
- Improvement related to customer requirements
- Resource needs to support the QMS.
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.
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?
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.
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
Supplier Quality Management Benefits, Responsibilities
There are benefits to creating strong relationships with suppliers from a customer’s perspective especially if a standalone supplier quality management function exists. Supplier measurement can take place, risk mitigation exercises (both reactive and proactive) can be accomplished and information and improvements can be shared for common gain. A supplier quality management function can create a community for all those involved , Account Managers, Supply chain Consultants, Supplier Performance Managers, in which they can integrate knowledge and deliver profit generating opportunities for both organizations through the exploration of additional, above and beyond current contract business opportunities .
Executive involvement is vital to the success of aligning the relevant strategic players to accomplish objectives and form the basis of building partnerships and ultimately unlocking value for both organizations. The Procurement functions should take the central role in coordinating supplier relationships, at the same time as owning and coordinating the process, authority and technology.
My Customer Wants Us Certified to AS9100, HELP!
You are a small business owner who has just been told you must become certified to AS9100 in order to continue to receive business from your largest customer. You have been putting this off for some time, hoping you would be able to wait until the economy gets better. Now what, you have a deadline and you haven’t got a clue how to get there from here? The best advice, find a competent consultant and get some training to the standard.
Those organizations who recruit good consultants get the job done roughly twice as fast. By helping you avoid mistakes, a good consultant can help you get the job done faster. But only a good consultant can do this. Not all consultants are created equally, and it is important to select a consultant that is right for you. A reputable consultant works hard to ensure that you fully own your quality management system at the time of registration. Key services you will require, if you have no idea what you are doing or how you will do it are as follows:
1. Required documentation development and implementation
2. Training: Quality policy and objectives, Management review, Corrective and Preventive action, Internal auditing, AS9100 Overview, Risk analysis, Overview of the Complete QMS, Collecting and analyzing data.
3. If software is being used to facilitate and run your quality system, you will also need training and implementation services for this.
4. Implementation of a competency, awareness and training program, internal audit, corrective and preventive action programs, management review and overall continual improvement programs.
5. Conduct internal audits for entire system (all processes), one high level internal audit to the AS9101C checklist in preparation for registration audit.
This is just a short list of services that you may need to accomplish your goal of certification to AS9100. Depending on the size and complexity of your organization and processes more may be needed. A good consultant can help you determine your individual needs.