Posts Tagged ‘continual improvement’
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 Customer Satisfaction How Do I Measure This?
ISO 9001:2008 requires that customer satisfaction is monitored but does not specify methods. You must decide how to satisfy this requirement in a way that makes since to your organization. What can you measure that will improve your customer satisfaction ratings and add value to your organization at the same time. Some measures you may consider are as follows:
1. Do you deliver on time?
2. Do you deliver in full?
3. What feedback do you get from sales or service engineers?
4. Are the key accounts growing?
5. Customer audits or report cards? If favourable, use them as evidence of customer satisfaction.
6. Direct feedback from the customer both positive and negative, track them. If enough customers are saying the same things about your company, you may want to put some measurement in place to resolve these issues. If they are saying something wonderful about you, make this a priority to provide this service to all your customers.
Remember, you are in business to grow and the best way to do this is to satisfy your customers. Focus on measurements that will result in setting you apart from your competition. Don’t give lip service to customer satisfaction because you will suffer a finding during your surveillance audit because you cannot produce evidence that you even know what your customers think of your performance. If you have a hard time determining what you should be measuring and analyzing, ask your customers what is important to them.
ISO 9001, What Should I Be Auditing and How Often?
The ISO 9001 standard does not specifically tell you what processes need to be audited or how often they should be audited. It does however state that the audits you do perform should be planned, and based on status and importance. So what does this translate to mean? Should you audit everything process every year, maybe, maybe not. The standard does not tell you how often, how many or what to audit, you decide what makes since for your organization (where can you get the most value and keep your quality system functioning as intended).
The best advise that I can give is review your process maps, non-conformances, past internal and third party audits, and determine where your quality management system needs attention. Where are the black holes that cause lost time, lost money, customer dissatisfaction (where are the points that are or could significantly impact your ability to satisfy your customer or grow your business). Answer these questions and you will be able to develop a planned audit schedule that will add value to your quality system. Don’t audit every process every year unless every process in your system is not functioning as you intended it to or does not meet the ISO 9001 standard requirements. If this is the case you would not be certified in the first place. Don’t audit for the sake of auditing this is costly and time consuming, get the most out of your internal audits by making them address real issues that can improve the entire quality system.
How many audits should you conduct each year? You decide how many audits will be enough to keep your quality management system functioning properly. Keep in mind, you cannot successfully improve your processes unless you periodically review them. Nothing stays the same, so if you don’t review your processes periodically they will come back to bite you via loss of business, non-conformances, increased costs, obsolete documentation, and ultimately loss of certification.
How Do You Define ‘Risk’?
Risk may be defined in terms of exposure to a hazard (an incident), likelihood of an incident occurring, and the consequences of the incident. It should be pointed out that the ‘outrage factor’ must be considered as part of the consequences of an incident. Public opinion of an organization can be greatly affected by the way it manages its risk,( especially in the area of Occupational Health & Safety). The outrage factor can greatly magnify risk.
Generally we cannot predict the consequences of an incident, so it is difficult to rate risks in order of importance, to provide a basis for distribution of resources to control risk. We can however, assess the likelihood of an incident by using statistics to measure probability in many cases.
In practice it is usually enough to identify hazards and take appropriate action to minimize the associated risk, based on reasonable expectation of the outcomes of exposure.
The term ‘safe’ is used to denote a situation or condition where there is minimal acceptable risk, i.e. where the risk is tolerable to stakeholders.
When determining what is acceptable risk, it is important to remember the ISO risk management principles:
- Risk management should create value
- Risk management should be an integral part of organizational processes
- Risk management should be part of decision making
- Risk management should explicitly address uncertainty
- Risk management should be systematic and structured
- Risk management should be based on the best available information
- Risk management should be tailored
- Risk management should take into account human factors
- Risk management should be transparent and inclusive
- Risk management should be dynamic, iterative and responsive to change
- Risk Management should be capable of continual improvement and enhancement
Finding an ISO 9001 Auditor that fits the needs of your company
Finding an ISO auditor that fits well with your company is fundamental to a successful certification experience. You want to work with a person that you are comfortable with and that is comfortable with you! Here are some tips that you can follow to find an auditor that you know you will work well with your company:
Try to find a registrar that has somebody who can answer your questions, someone that you feel comfortable with and meets your financial requirements. Make sure the registrar has auditors with experience in your area. What good is a registrar that has an auditor that lives down the street from you if they’ve only audited service processes? They’ve never audited a machine shop, and you’re a machine shop.
You want an auditor that fits you and your company and gives you good observations and opportunities for improvement as they audit. Ask to talk with your potential auditor. It’s always nice to be able to converse with somebody so you get to know who they are before you meet them. If they are in the area, maybe they can drop in just to talk to you, just to put a face to the name.
Some registrars have auditors all over the United States and even some overseas. Be careful when you are trying to find an auditor close to you. Sometimes you are going to find that the auditor you like isn’t close to you. If you like that person, and are willing to pay travel expenses, the registrar should be happy to send that person to you.
Remember you are the customer, make sure you exercise your right to selecting the auditor that best fits your needs.
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?