As a prerequisite to guarantee compliance with AS9100C, aerospace engineers must understand why the AS9100 standard was modified with the revisions present in its current version, “C.” Recent revisions to the ISO 9001 and AS9100C standards, as characterized in ISO 9001:2009 and AS9100C, expand and define the need to control Risk, Critical Items, and Key Characteristics. Also covered under these revisions is the need to possess a better understanding of Configuration and Risk Management.
If you are able to understand both “the intent” and “the definition” of these key-additions to the AS9100 standard, you will know when you are making a right decision to add or delete processes and requirements within your operations.
First, we must understand why changes were necessary to the AS9100C standard. The rational behind these changes, as stated in AS9100C, is the revision of the standard to incorporate the requirements of ISO 9001:2008, which was updated as a result of the challenging times inherent in today’s global business environment.
Globalization of business has led to great diversity in regional and national requirements. Over the years, we have evolved from an industrial nation to a service industry, and our expectations have complicated our objectives. Outsourcing has become a business practice for many manufacturers of aerospace, medical device and other products. Business models are no longer based on the development and manufactured products, from start to completion. Rather, companies that were once manufacturers have become importers or “kitters.”
Kitting is a business model that relies on parts that are imported from all over the world, that are assembled, often by a third-party located offshore in Central and Latin America or Asia Pacific. The assembler will then affix the so-called manufacturer’s logo before the product is sold into the marketplace.
All of these processes must be manages properly, which creates new and exciting challenges that require discipline and commonsense to properly define responsibility and authority without compromising customer, statutory and regulatory quality management system requirements. The following diagram illustrates the evolving business environment here in the United States.
New Definitions in AS9100C
The new definitions in AS9100C are expressed for good reason, they represent product or service specific objectives that have to be captured during the contract review and planning process.
During the planning process each attribute is identified as a Configuration Item, Risk, Special Requirements, Critical Item or any other Key Characteristic that must be treated as an objective. This means that the attribute is important, and important items are always in the light, on a traveler, or recorded in a specific report. Key definitions and meanings are:
Configuration Management (CM) – The sole purpose of configuration management is to insure that a product maintains the same design, materials, composition or processing that as was originally intended by the owner from delivery through its entire lifecycle.
Configuration Items (CI) – Are used to identify specific attributes for configuration management.
Project Management – Plan and manage product realization in a structured and controlled manner, to meet requirements at acceptable risk, within resource and schedule constraints.
Risk – An undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.
Special Requirements – Those requirements identified by the customer, or determined by the organization, which have high risk associated with them.
Critical Items – Those items having significant effect on the product realization and use of the product including safety, performance, form, fit, function, producibility, service life.
Key Characteristic – An attribute or feature whose variation has a significant effect on product fit, form, function, performance, service life or producibility, that requires specific actions for the purpose of controlling variation.
It is important to note that special requirements and critical items, along with key characteristics, are interrelated. Additionally, any of the above that are identified by the customer statement of work, purchase order, or listed on a drawing are objectives that must be reported back, and captured and documented in the form of specific report or one on your traveling/work order.
Applicable Statutory and Regulatory Requirements
The foreword to AS9100C states that, “to assure customer satisfaction, aviation, space and defense organizations must produce, and continually improve, safe, reliable products that meet or exceed customer and applicable statutory and regulatory requirements.”
Regulatory authorities are commonly set up to enforce standards and safety, to oversee use of public goods and regulate commerce. Examples of regulatory agencies are the Interstate Commerce Commission and U.S. Food and Drug Administration in the United States, Ofcom in the United Kingdom, and the Telecom Regulatory Authority of India (TRAI) in India.
Statutory law or statute law is written law (as opposed to oral or customary law) set down by a legislature, or other governing authority such as the executive branch of government, in response to a perceived need to clarify the functioning of government, improve civil order, to codify existing law or for an individual or company to obtain special treatment (Contrast common law). In addition to the statutes passed by the national or state legislature, lower authorities or municipalities may also disseminate administrative regulations or municipal ordinances that have the force of law. The process of creating these administrative decrees is generally classified as rulemaking. While these enactments are subordinate to the law of the whole state or nation, they are nonetheless a part of the body of a jurisdiction's statutory law.
Regulatory capture is a term used to refer to situations in which a government regulatory agency created to act in the public interest instead acts in favor of the commercial or special interests that dominate in the industry or sector it is charged with regulating. Manufacturing organizations have the challenge of purchasing products from suppliers throughout the world and at all levels of the supply chain. Suppliers have the challenge of delivering products to multiple customers having varying quality expectations and requirements.
With the above education, you are now ready to jump into reviewing AS9100C changes, and applying them in a logical and practical way. In section 7, paragraph 7.1.4, the requirement identifies the controls necessary to transfer work to other facilities or suppliers. Because you now understand today’s globalization and outsourcing, you are then responsible for whatever you outsource. As such, it makes sense for us to either establish a Traveling Work Order or have our supplier establish a Traveling Work Order that YOU approve with all the attributes (Key Characteristics, Configuration items, acceptance requirements, etc.) in the instructions before the subcontractor starts work on our product. You may also have the subcontractor submit a First Run Sample for your approval before the Full Production Run. In this scenario you used Globalization, Definitions, and Standard to make a logical decision about how to apply the new addition Section 7.1.4 to your company’s business practice. Note that your planning procedure should address how to handle “Control of Work Transfers.”
Today’s aerospace engineering must take advantage of the biggest reason that AS9100C was revised, which as stated in the quality management system is “the globalization of the industry and the resulting diversity of regional and national requirements and expectations have complicated this objective. Organizations have the challenge of purchasing products from suppliers throughout the world and at all levels of the supply chain.”
Suppliers are challenged in delivering products and maintaining configuration management relative to multiple customers who have varying quality requirements and expectations. Your job security lies in our ability to understand and implement both current and future quality management systems. Under no circumstances should you underestimate the power you have to lead your company into a future of manufacturing practices that produce high quality products conforming to statutory, regulatory and customer requirements.