AS9100 Rev D Operation
- Plan and establish controls for all operational processes.
- Define requirements for products and services and ensure claims for products and services offered are met.
- Establish, implement, and maintain an appropriate design and development process.
- Ensure externally provided processes, products and services conform to requirements.
- Production and service provision must be performed under controlled conditions.
- Products and services are not to be released until after verification that requirements have been met.
- Nonconforming outputs are to be identified, controlled, and addressed.
- This section has several references to statistical tools to support your QMS, learn more about these tools.
Section 8 Operation
Section 8.1: Operational planning and control
Planning for your operation’s processes and the controls that will be put in place is required to ensure product and service requirements are met. When determining what those requirements are consider things like safety, production, inspection, reliability, packaging, and recycling. Once the requirements are determined, establish acceptance criteria for processes, products, and services. This will help you to plan what controls need to be in place and the resources needed to maintain control of your processes. Those controls must also address prevention of counterfeit parts (i.e. verification) and product safety (i.e. safety training).
Consider using statistical techniques to support control of your processes such as control charts or check sheets. Documented information such as routing sheets, procedures, work instructions, and tags/labels are likely essential to maintain control of your processes.
To meet the requirements around operational planning and control you must also have a process for risk management and configuration management.
Section 8.2: Requirements for Products and Services
Customer communication is essential for determining product and service requirements and ensuring you are meeting those requirements. Customer communication must include information related to products and services, enquiries, contracts, orders, changes, feedback, handling customer property, and requirements for contingency actions.
Determine if there are any special requirements or statutory and regulatory requirements that need to be met. After requirements for products and services have been defined, review them before committing to customers. Ensure you can meet those requirements; do not make promises you cannot keep. If you find that certain requirements cannot be met, discuss these with the customer and come to a mutual agreement for what is acceptable. The results of this review as well as any new requirements or changes to requirements must be recorded.
Section 8.3: Design and Development of Products and Services
If you do not design or develop any of the products or services you offer, the requirements in clause 8.3 can be excluded from your quality management system (QMS). If you do design and develop, this is likely your most complex process. Because of this, you are required to establish a design and development process that defines all activities, stages, responsibilities and authorities, verification and validation, resource needs, involvement of customers, the level of control necessary, and documented information needed to demonstrate this process is conforming to its own requirements and AS9100.
The inputs into your design and development process should include performance requirements, information from similar designs, statutory and regulatory requirements, standards that the organization has committed to, and the potential consequence of failure or obsolescence.
Place controls over your design and development process such as reviews, verification and validation activities, and proper authorization for progression to the next stage to ensure that requirements for the product or service will be met.
Information for how the product or service should be identified, manufactured, verified, used, and maintained should be defined. Consider production processes, acceptance criteria, key characteristics, and input requirements when developing BOMs, drawings, assembly instructions, and how product will be handled and packaged.
If changes are to be made during design and development, they need to be controlled in accordance with the configuration management process to ensure they will not negatively impact the product or service. Establish a process and the criteria for when changes require customer notification and approval.
Section 8.4: Control of Externally Provided Processes, Products and Services
It is your responsibility to ensure your suppliers, regardless of whether designated by your customers or not, conform to your requirements and do not affect your ability to provide conforming products and services.
Controls must be put in place for any supplier that provides products or services directly to your customers (i.e. distribution), supplies raw materials for your finished goods (i.e. manufacturing) or is subcontracted to perform a process.
The controls to be applied must include a supplier register with approval status, scope of approval, periodic performance reviews, defined requirements for handling documented information, what actions will be taken in the event that a supplier does not meet your requirements, verification activities (i.e. incoming inspection or periodic testing) and any other controls your organization feels are necessary.
In order for your suppliers to fully understand your expectations you need to clearly communicate all requirements and explain their contribution to product and service conformity and to product safety.
Section 8.5: Production and Service Provision
When producing a product or providing a service, the conditions in which these activities are performed need to be controlled. Controlled conditions include but are not limited to documented information (e.g., routing sheets, work orders, labels, work instructions, etc.), calibrated or verified equipment, suitable environment and infrastructure, competent employees, validation and verification activities, human error prevention, in-process inspection, and first article inspection (FAI).
Outputs of product and service provision are to be identified if it is necessary to ensure conformity with requirements. For example, a part that passes or fails a validation activity or inspection needs to be identified as such. Also, take into consideration any traceability requirements. For example, if you need to have the ability to recall inspection results for a provided service or product, consider how you will maintain traceability to those inspection results (i.e. production dates, job numbers, lot control, etc. referenced in an inspection report).
Other requirements for product and service provision include those around post-delivery activities, caring for customer or supplier property, preserving outputs, and controlling changes.
Section 8.6: Release of Products and Services
Before releasing a product or service, you must verify that requirements have been met. For example, have documentation that confirms a part or service passed inspection, meets specifications, and a relevant authority approved its release.
Section 8.7: Control of Nonconforming Outputs
Nonconforming products or services whether received from your supplier, generated internally, or reported by your customer must be identified and controlled. Nonconforming outputs need to either be corrected, segregated, contained, returned, provision suspended, the customer informed, and/or authorization obtained for acceptance under concession.
In addition, you are required to have a control process for nonconforming products and services that includes responsibilities and authorities for reviewing and assigning dispositions, containment actions, reporting to interested parties, and corrective actions for nonconforming products and services detected after delivery.
Records of nonconforming outputs must include a full description of the problem, corrective actions, any agreed upon compromises reached with the customer, and who authorized the actions taken.
Please note that certain text from the AS9100 standard is only used for instructional purposes. Standard Stores recognizes and respects the SAE International copyright and intellectual property guidelines.