Mark Hammar When reading through the requirements of AS9100 Rev D to discover what needs to be done to implement an aerospace quality management system (QMS), many people overlook the appendices that are included to help you better understand what the standard requires. In this article I would like to quickly describe the eight sections of Appendix A, entitled: “Clarification of New Structure, Terminology and Concepts”.
Structure and terminology (Appendix A1)
This section explains how the standard has changed to align with other management standards. It also points out that the model of the standard is to give a coherent way of implementing, rather than dictating, how your QMS document structure needs to look (i.e. you don’t need to number your documents the same as the standard). The appendix also clarifies that there is no requirement for organizations to change their terminology to align with the standard. For instance, if you want to continue to use the terms “document”’ and “record” in your QMS rather than “documented information,” that is perfectly acceptable.
Products and services (Appendix A2)
Appendix A2 discusses the change in the standard form using the term “products” to using the term “products and services”. This is intended to highlight that even companies who supply products to their customers also supply services (such as a delivery service) so that the conformity of the requirements cannot be fully realized until the product is fully delivered to the customer. This change flows through many requirements of the standard.
Interested parties (Appendix A3)
This appendix makes clear that it is up to the organization to determine if an interested party is relevant to their QMS, and therefore whether or not their requirements are taken into account. The key factor is whether an interested party is relevant to the scope of providing consistent products and services that meet customer requirements, and try to enhance customer satisfaction. If a requirement of an interested party does not affect this, then the organization can legitimately discount it.
Risk-based thinking (Appendix A4)
This section better explains that the concept of risk-based thinking has replaced preventive action in AS9100 Rev D, and that one of the key purposes of having a QMS is as a preventive tool. Although the concept of risk-based thinking has been implicit in previous versions of the standard, this revision makes it explicit with requirements to include this thinking within the organizational planning activities.
This section goes on to further clarify that, for QMS risks, there is no requirement for formal risk management activities or a documented risk management process. However, as with past standard requirements there is an additional requirement for operational risk management to better understand and take action on risks that impact the operational processes.
Applicability (Appendix A5)
With the term “exclusions” removed from the standard many people were concerned that they could not identify requirements that did not apply to their QMS. This section clarifies the change. The ability still exists for an organization to determine requirements of the standard that are not applicable to their QMS, and these requirement do not need to be applied.
Documented information (Appendix A6)
The change from documents and records to ‘documented information’ is explained in this appendix. There is further discussion of the need to retain documented information along with retaining it (such as previous versions of a procedure). It also clarifies that, where the standard mentions information rather than documented information (such as the review of internal and external issues), this information does not necessarily need to be documented. Remember: according to Appendix A1, any change within your organization to using this new terminology is strictly optional.
Organizational knowledge (Appendix A7)
A further explanation of the clauses regarding organizational knowledge is given here, including why these requirements were introduced. It was identified that organizations needed to safeguard themselves from the loss of knowledge (such as through staff turnover), as well as encouraging organizations to acquire knowledge (such as learning from mentoring or benchmarking).
Control of external providers (Appendix A8)
To better explain the change from purchasing requirement to requirements for control of external providers, some examples of the forms of external providers are discussed. These forms include purchasing from a supplier, arrangements with a associate company, or outsourcing processes to an external provider. Since all outsourcing has an element of risk, it is encouraged to apply the model of risk-based thinking when determining the level of controls required for each of your external providers. The level of control will depend on the risk level presented.
Use Appendix A to better explain what is needed
The reason Appendix A is included in AS9100 Rev D is to explain some of the reasoning behind the changes in the standard. Reading Appendix A can give you some insight into what you need to do to comply with the new requirements. By using this information you can avoid unnecessary and costly changes in your QMS, such as re-numbering all of your documentation to match the standard clauses, which will not improve your processes at all. Make sure you do only what is beneficial for you when aligning your QMS to the AS9100 Rev D requirements, not something unnecessary to please others.
Use this AS9100D List of mandatory documents to see in which documents the clarifications of annex A needs to be implemented.
