Mark Hammar If you already have an aerospace Quality Management System (QMS) in place, you will know that the newest release of the AS9100 Rev D standard means that you will need to make some changes. While many of your QMS processes will remain unchanged by the new revision, there are a few new requirements that you will need to incorporate. Here are 12 simple steps to help you transition to the new standard:
1) Define organizational context
AS9100 Rev D incorporates a new requirement for defining the context of the organization—the factors and issues (internal and external) that can affect your QMS. For instance, what cultural, economic, legal, social, or technological factors could influence the purpose, objectives, and sustainability of your QMS?
Read more about organizational context here: AS9100: Understanding the requirements of context of the organization.
2) List the interested parties of your QMS
Another new requirement of AS9100 Rev D is to understand the interested parties of your QMS. Who are those people and entities that may be affected your company decisions regarding providing your products and services? You will need to identify these parties, assess their needs and expectations, and then decide which needs will become obligations for you to meet.
3) Review QMS scope
If you already have a QMS in place, then you will already have a QMS scope identified. There is no requirement to change your scope if it is still applicable, but after identifying the context and interested parties for your QMS you may want to review the scope to determine whether a change is needed. For your QMS to be effective, you need to have a good scope defined, so why not do a check now for the adequacy of your QMS scope?
4) Re-affirm leadership
In order for any QMS to be successful, it needs top management to be involved, and this is emphasized in AS9100 Rev D. With responsibilities for QMS scope and results, aligning objectives with the company strategy, communication, company culture, policies, resources, and processes, it is clear the top management is involved in every aspect of the QMS.
Find out about the management representative in this article: Is the management representative still required in AS9100 Rev D?
5) Align your QMS objectives with your strategic direction
Not every company has written down the strategic direction that top management has determined. With the new requirement to align your quality objectives with your strategic direction, more people will need to understand what this direction is, so now is the time to ensure that it is properly identified and understood by those who need to meet the quality objectives of your company. Your business strategy and quality objectives will be reliant on each other more than ever before.
For a better understanding, see: How to define quality objectives in AS9100.
6) Identify risks and opportunities
While previous revisions of AS9100 have involved managing organizational risk, there is a new requirement for the QMS to include risk-based thinking by considering the risks and opportunities that exist for your QMS. After identification, you then need to decide what you intend to do about the risks and make plans to perform necessary actions. This is intended to become an integral part of all major QMS planning and decision-making processes.
7) Control your documented information
Previous QMS requirements have talked about documented procedures and records, but this has been replaced by the term “documented information” in AS9100 Rev D. The requirements for control of documented information are very similar to previous requirements; however, with this change it is a good chance to review what you have documented within your QMS. Maybe you can replace a wordy procedure with a flowchart, so why not take this opportunity to improve your documentation system?
8) Operational control
In short, these requirements are about defining the criteria needed to deliver on your products and services, and ensuring the availability of resources and documentation to deliver on these criteria. Although much may stay the same, reviewing this aspect of your business is a good idea. Remember to include the important aerospace requirements for operational risk management, configuration management, product safety, and prevention of counterfeit parts controls in your operational controls.
9) Review your process for design and development
AS9100 Rev D changes the level of control for design and development, so check that your current system is as far reaching as it needs to be to ensure that your products and services retain the integrity necessary to meet customer needs. For instance, can you provide the evidence of who approved design changes and how that person is deemed qualified to make those changes?
10) Review control of external providers
What used to be “purchasing” in the previous standard is now “control of externally provided processes, products and services.” Can you illustrate the exact specifications, quality, timeline, and cost expectations for your outsourced processes, products, and services so that the external providers know exactly what you require?
11) Evaluate performance
Are your QMS processes adequately implemented and effective? How do you document the results of your performance evaluations to demonstrate QMS effectiveness? These requirements help in developing continual improvement initiatives in your QMS.
12) Monitoring and measuring
Several clauses in AS9100 Rev D have become more specific about what to monitor and measure, so check to ensure that you are monitoring everything that the standard requires. One example is that AS9100 Rev D tries to make internal audit and management review “measurable,” where they were not before, so now these processes are open to finding improvements.
Transition before time runs out
While you may not need many changes in your core QMS processes, remember that the transition to AS9100 Rev D needs to take place before September 2018, so don’t delay in the review of your QMS and the addition of the small changes. A methodical approach is your best course of action in the short time left.
If you are implementing a QMS based on AS9100 Rev D, and want to understand the implementation process better, why not check out this free downloadable AS9100D Implementation Diagram?
