What an Upgrade to AS9100C Involves?
We have trained and skilled consultants who can upgrade your existing documents and train on implementation of the additional requirements. Look at the extensive list below and see what our value added services will provide.
(Bold headings = ISO 9001 Structure / Bullet points = AS9100C:2009 Additions)
Quality Management System
- QMS controls must include addressing all customer and regulatory requirements applicable to QMS
- All employees must have access to relevant documentation
- Records control procedures must include how suppliers control their records at their site
Management Responsibility
- Customer focus includes measurement and appropriate actions related to quality and on-time delivery at a minimum
- Management representative must have organizational freedom to resolve matters pertaining to QMS
Production Planning – Project Management
- Detailed planning and management from concept to completion
- Project must be completed within resource and schedule constraints
Production Planning – Risk Management
- Implementation of risk mitigation
- Target is managing risk down to a measurable level where remaining risks are acceptable
Production Planning – Configuration Management
- Huge requirements for designers to establish a “family” connection for all parts
- Others need a procedure as well to control their role in configuration management
Customer Related Processes
- Reviews of requirements include determination of special requirements
- Risks (technology, delivery time frames) must be identified
Design and Development
- Design and development planning must be more detailed
- Design must identify special and key characteristics
- Design and Development Verification and Validation Testing require a procedure
- Design and Development Verification and Validation require special documents
Purchasing Requirements
- All suppliers require evaluations that are more rigid and intense
- Purchasing orders require additional specifics that purchasing documents require (the “flow down” effect)
- Receiving inspections – additional verification activities (validation of test reports; customer representation)
Production Requirements
- Production requires detailed accountability controls and work instructions
- Production Process Verification (First Article Inspection) must be controlled an documented
- Production documentation must cover every step in detail (travelers are required)
- Production process changes must be controlled
- Production equipment, tools and software must be validated
- Production and inspection stamps must be controlled
- Must have a FOD (foreign object detection) program
- Calibration – specific register information and control of environmental conditions
Customer Satisfaction
- Customer satisfaction measurements include product conformity, on-time delivery performance, customer complaints and corrective action requests
- You must develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results
Monitoring and Measurement of Processes
- Required to take appropriate action to correct the nonconforming process
- Must evaluate whether the process nonconformity has resulted in product nonconformity
- Then determine if the process nonconformity is limited to a specific case or whether it could have affected other processes or products, and
- Identify and control any nonconforming product per 8.3
Monitoring and Measurement of Product and NC Product Control
- Inspections require appropriate sampling and monitoring of critical items including key characteristics
- Inspection documentation must contain much more information
- Must ensure that all documents required to accompany the product are present at delivery
- Additional procedural requirements related to approving personnel for NC dispositions, restrictions on re-grading, “use-as-is”, and scrap
- Controls include timely reporting of delivered nonconforming product
- Take actions necessary to contain the effect of the nonconformity on other processes or products
Analysis of Data
- Must monitor the implementation of improvement activities and evaluate the effectiveness of the results
Corrective Action
- Must flow down corrective action requirements to a supplier when it is determined that the supplier is responsible for the nonconformity
- Procedure details specific actions where timely and/or effective corrective actions are not achieved
- Procedure determines if additional nonconforming product exists based on the causes of the nonconformities and taking further action when required