The Fulfillment of AS 9100 Rev C Requirements by EnterpriseIQ

Transcription

1 The Fulfillment of AS 9100 Rev C Requirements by EnterpriseIQ Manufacturers have worked to meet the stringent requirements of AS9100 for decades; the recent introduction of Revision C has further expanded documentation and traceability requirements. To help maintain AS9100 compliance and avoid increased audit frequency, manufacturers systems must include strong traceability capabilities, document controls and record storage. AS 9100 Rev C includes all the requirements of ISO 9001:2008 along with additional requirements. IQMS capabilities to comply with the ISO 9001:2008 & AS 9100 Rev C requirements are highlighted in blue type. Note: This high level summary does not include a detailed analysis of the 188 Shall Statements in AS9100C. Responses to ISO 9001:2008 & AS9100 Rev C items: 1. Determine the processes needed to meet customer requirements (i.e., sales & distribution, purchasing, production, training, maintenance, etc.). (4.1) Inside EnterpriseIQ, customer requirements can be mapped out in a workflow to ensure they are being complied to. Audits then can be scheduled using the EnterpriseIQ Quality Audit Module against these processes to determine their effectiveness. 2. Determine how outsourced processes will be controlled. (4.1) Within EnterpriseIQ s Supplier Central, compliance of quality standards can be logged and maintained. Internal processes then can be used for receiving inspection of the materials the outsource provider is returning to provide checks. Also, supplier field audits can be tracked and managed within the Quality Audit Module and a supplier performance scorecard can be supplied. 3. Determine how processes relate to each other, how processes are managed and explain what is measured to demonstrate effective process management. (4.1 b, c) By conducting quality checks at time of receiving or production inspection, users can provide 100% coverage. Criteria can be established that prevents any amount of bad product from being released for use in process or shipment to customers. Using the EnterpriseIQ SPC module, users can quantify the values at the part or process level. This information will also affect the supplier performance scorecard. 4. Demonstrate resource availability to ensure each process is effective. (4.1 d) Internal processes in EnterpriseIQ allow the customer to identify resource availability by dictating the resource needed at each process level. EnterpriseIQ s

2 Labor Capacity Whiteboard tool can identify the areas with shortages and or gaps. 5. Ensure processes achieve the planned results. (4.1 e,f) The EnterpriseIQ SPC module is used to set control limits and any inspection values that fall between the limits will be acceptable, but noted toward trending out of control. Inspection values outside the control limits will be documented and highlighted as out of specification. 6. Companies must have a quality manual. (4.2.2) Although the company must develop the quality manual outside EnterpriseIQ, the EnterpriseIQ Document Control module can be used to track electronic employee approvals and reviews of the quality manual and all revision history would be contained within EnterpriseIQ. 7. Documents used by the quality management system must be controlled. (4.2.3) The EnterpriseIQ Document Control module can be used to track electronic employee approvals and reviews of the quality manual and all revision history would be contained within EnterpriseIQ. 8. Records used by the quality management system and records created or retained by suppliers must be controlled. (4.2.4) The EnterpriseIQ Document Control module can be used to control all documents and records, (including the linking of documents to purchase orders, the supplier master, receipts, material lot numbers, etc.) so any inspection results or documentation provided by suppliers can be tracked. The EnterpriseIQ Quality Audit module can be used to document any supplier audits to ensure compliance to records retention and tracking at suppliers. 9. Top management must show commitment to the quality management system. (5.1) This requirement would be fulfilled outside the ERP system by the company running the EnterpriseIQ software system. 10. Determine customer requirements and deliver those requirements on time. (5.2) EnterpriseIQ will track customer orders and on time deliveries and provide a customer satisfaction summary by RMAs and any open support issues or nonconformances. 11. Measure and record conformance with quality issues and on-time deliveries and take appropriate actions to address deficiencies. (5.2) EnterpriseIQ provides reports and key performance indicators to track customer satisfaction. 12. Establish a quality policy that is understood by all employees. (5.3) While it is the company s responsibility to develop the plan, the EnterpriseIQ Workforce module can be used to manage all employee training levels and

3 competencies to ensure that all employees are trained on and familiar with the company s quality policy. 13. Establish a quality policy that meets customer requirements. (5.4.1) The EnterpriseIQ Quality modules allow for quality objectives that are relevant to customers to be called out and documented as part of the PPAP/APQP process where the control plan would dictate the process and controls in place to ensure they are within compliance. 14. Plan and document how you will meet the needs of your customers. (5.4.2) EnterpriseIQ allows for all customer requirements and documentation of procedures followed to be modeled in workflows that are inherent throughout the system. Electronic signatures record the responsible parties procedural signoffs at each step in the process. 15. Make sure employees understand their responsibilities with regards to the Quality Management System. (5.5.1) The EnterpriseIQ Workforce module provides the tools to document and store verification that employees are trained and tested with regard to the effectiveness of the quality initiatives and directives of the company. 16. Appoint a management representative who will ensure that the Quality Management System remains effective after implementation. (5.5.2) This requirement would be fulfilled in the EnterpriseIQ software system when the company designates a management representative with this responsibility. 17. Communicate with the organization how you are doing in meeting the objectives. (5.5.3) Key performance indicators and metrics can be modeled in EnterpriseIQ Smart Page. These can then provide everyone within the organization real-time visibility to company performance against the established objectives. 18. Management must periodically review/evaluate the Quality Management System. (5.6) EnterpriseIQ supports tools, including calendar tools, workflows and audits, to schedule and document management review meetings related to the QMS. 19. Ensure employees are competent/qualified to do the tasks required and keep records of the training received. (6.2.1/6.2.2) The EnterpriseIQ Workforce module, in conjunction with the Time & Attendance module, can provide the controls to ensure that only certified employees have access to log into work orders. Certified employees would be employees that have received specific training and the training is up to date. 20. Make sure that the tools, equipment, workspace, etc. needed to meet customer requirements are provided. (6.3/6.4)

4 All tooling, equipment, work instructions, raw materials, components, packaging, labor certifications and other necessary items are called out as part of the recipe and are stored at the Bill of Material (BOM)/routing level. This ensures that all required items are available prior to starting production. 21. Create and improve your process for delivering what your customers want. (7.1) The EnterpriseIQ Product Lifecycle Management module, which incorporates APQP, FMEA, PPAP and Control Plan components, provides the tools (including workflows with electronic signature signoff) to define the process of designing and manufacturing customer product and continuously audit the effectiveness of the process. Customer satisfaction surveys along with customer signoff on workflow events can continuously provide customer insight. 22. Take a project management approach as necessary to meet customer requirements while taking risk into account (7.1.1) The EnterpriseIQ Project Manager module provides complete project management capability as part of the ERP system. This includes management of milestones and checkpoints. 23. Create and maintain a process for assessing and managing risks related to meeting customer requirements. (7.1.2) This requirement would be fulfilled outside the ERP system by the company running the EnterpriseIQ software system. 24. If appropriate, have a process for managing product configuration. (7.1.3) EnterpriseIQ supports a rules-based product configurator that allows for control over the configuration of a product. The product configurator can be used in conjunction with other quality management controls like ECO, PPAP, FMEA and Risk Assessment. 25. Have a process for managing and controlling work transferred outside the organization. (7.1.4) EnterpriseIQ has tools to manage the entire supply chain, including: Supplier Central for managing contacts and the entire supplier experience, Outsource Central for visibility of materials shipped to suppliers, drop ship suppliers and vendor performance scorecards to ensure supplier rating maintenance. 26. Identify and track customer requirements. (7.2.1) The EnterpriseIQ Customer Relationship Management module, along with tools like APQP, Product Lifecycle Management, workflows that can include customer sign-off, tracking of customer metrics like on-time shipments, PPMs, etc., provides superior tools for tracking customers and their unique requirements. 27. Review customer requirements before accepting orders. (7.2.2) EnterpriseIQ provides tools for contract review and approval workflows within the Customer Relationship Management module.

5 28. Create and document process for customer communication. (7.2.3) Using multiple tools within the EnterpriseIQ ERP system, including workflows and web portals, customers can have access to reports provided to them on a realtime basis. 29. Ensure what is purchased meets your requirements. (7.4.1) EnterpriseIQ utilizes receiving inspections to ensure this is followed and provides attribute and variable data as evidence. 30. Manage your suppliers, have an approved vendor list, periodically evaluate suppliers and use evaluations to determine the level of control required. (7.4.1) EnterpriseIQ allows for approved suppliers and assignment of a default supplier, including a supplier score card based on quality, delivery, price, etc. Supplier quality specialists can use the Quality Audit module to manage and track external audits on suppliers. 31. Evaluate/manage risk when selecting and using suppliers. (7.4.1) Criteria can be defined and the use of user-defined forms and fields help track pertinent information on each supplier. 32. Ensure suppliers have all the information necessary to meet your requirements. (7.4.2) EnterpriseIQ provides web portals to allow suppliers direct access to pertinent information. Secondly, suppliers can be included on workflows with electronic signature signoff when communication is called out as a necessary part of the process or step. 33. Ensure suppliers are provided with relevant requirements from your customers. (7.4.2) The EnterpriseIQ APQP module provides capability to allow requirements to flow from a customer to a supplier. Since it is an outsourced step or process, it is critical to maintain the elements involved. 34. Ensure that purchased items meet quality requirements. (7.4.3) EnterpriseIQ provides tools to ensure that all purchased products can be required to have receiving inspection and stores documentation of the results of the inspection. EnterpriseIQ can also control sources of product from only approved suppliers. 35. Ensure that production is carried out under controlled conditions. (7.5.1) The EnterpriseIQ RealTime Production and Process Monitoring and SPC modules provide feedback on manufacturing processes as they are happening and can highlight processes trending out of specification. 36. Have a process for controlling how changes to the production process are made. ( ) Changes in production can be controlled and documented within ECO workflows.

6 37. Define how equipment and tooling will be stored and managed. ( ) The EnterpriseIQ Preventative Maintenance module provides capabilities for managing equipment and tooling with full documentation, usage and financial tracking. 38. Make sure that unique customer documentation requirements for a product are identified and tracked during the production process. (7.5.3) Within EnterpriseIQ, customer-specific monitoring and label requirements can be addressed at the product and process level. 39. Ensure that the state of inspection of a product can always be determined during production. (7.5.3) For any inspection required during the manufacture of a product, EnterpriseIQ can track the time of inspection and tie the inspection to a work order or lot number, as well as the user conducting the test. 40. Establish controls for acceptance media. (7.5.3) EnterpriseIQ provides for customer-specific details that can be set up in the customer master user defined fields and forms. Each customer can also have specific customer reports. 41. As required, ensure that the system can trace all sources for materials used in manufactured products. (7.5.3) The EnterpriseIQ single database provides certificates of conformance, lot number (both manufactured and purchased products) and serial number tracking with reverse lot number look-up. By containing all of this information in one comprehensive database, companies can quickly identify any bad components and see where else they are used. 42. Ensure that all customer owned materials and tooling are maintained properly and customers notified of damage or loss. (7.5.4) Customer owned inventory can be tracked throughout the system and tooling can be tracked in the Preventative Maintenance module (including costs for maintenance and repair). Other customer assets can be photographed and identified at the customer record for external documents. 43. Ensure that products to be shipped are not damaged. (7.5.5) EnterpriseIQ supports the Final Inspection process that prevents inventory that has not been properly inspected from being shipped. The MRB module can also be used to track the sign off process for ensuring properly made product. 44. Ensure that all tools and equipment used for monitoring and measuring are calibrated to NIST standards and that records are maintained. (7.6) All items can be tracked and maintained in the EnterpriseIQ Gage Calibration and Testing module. Safeguards at time of inspection prevent use of tools and equipment that are not current on their calibrations.

7 45. Maintain a list of monitoring and measuring equipment along with specifics of calibration method and acceptance criteria. (7.6) All items can be tracked and maintained in the EnterpriseIQ Gage Calibration and Testing module. 46. Ensure that proper environmental conditions for calibration and inspection. (7.6) EnterpriseIQ provides tools to record environmental conditions at the time of calibration and testing and alerts if conditions are not acceptable. 47. Define and implement a process for scheduling calibration of monitoring and measuring equipment. (7.6) EnterpriseIQ can be configured to provide alerts to initiate the request for calibration prior to expiration dates. 48. Periodically determine whether your customers believe you are meeting their requirements and modify processes to correct deficiencies. Follow up on effectiveness of corrections. (8.2.1) The EnterpriseIQ CRM module supports customer satisfaction tracking and scoring. The Quality Audit module can be used to supplement tracking of actions. 49. Conduct internal audits to see if you are meeting requirements of AS 9100, internal quality systems (including quality system procedures and customer contractual requirements). (8.2.2) The EnterpriseIQ Quality Audit module was designed specifically to meet this requirement. 50. Fix problems uncovered during audit and document steps to prevent reoccurrence. (8.2.2) All Non-Conformances or problems identified during the audit can be linked and addressed within the EnterpriseIQ Corrective Action module. 51. Determine/ensure that processes are effective. (8.2.3) The EnterpriseIQ Quality Audit module supports the tracking and documentation of regularly scheduled audits on parts, processes, and suppliers. 52. Monitor and measure the products you make to ensure customer requirements are met. (8.2.4) The EnterpriseIQ SPC, Gage Tracking and Process Monitoring modules allow for capture and analysis of all specifications required to ensure that products are made to customer specification. 53. Requirements for acceptance include criteria for acceptance/rejection, operation testing requirements, records to be kept, test equipment to be used and how it must be used. (8.2.4) The EnterpriseIQ SPC module allows for inspection tests to be approved and defined within inspection set-up and monitored through the SPC and Process

8 Monitoring modules. The Gage Tracking module allows for tracking of gage calibration results. 54. Identify and segregate items that do not meet customer requirements and document measures taken to ensure that Non-Conforming products are disposed of correctly. (8.3) EnterpriseIQ offers a complete Material Review Board (MRB) module that can provide workflow processes for containing any Non-Conforming products. The software also has controls to prevent Non-Conforming products from being shipped or used in process. 55. Non-Conformances should be handled in a timely manner. (8.3) EnterpriseIQ s MRB module (along with other quality modules) supports workflows that can have duration times identifiable at the individual step level. EnterpriseIQ is capable of reporting on those steps not completed within a timely matter with expedite capability. 56. Periodically review and analyze information about what customers think about you, your ability to meet customer product requirements, how good your processes are, and how good your suppliers are doing. (8.4) EnterpriseIQ meets the above via a combination of customer satisfaction reports and open/closed technical support issues in CRM, overall effectiveness with APQP requirements and a rating by the customer, audited and inspected processes with results being recorded and monitored, and supplier performance analysis scorecards. 57. Overall performance of the quality management system needs to improve and the improvement activities should be monitored for their effectiveness. (8.5.1) The EnterpriseIQ Quality Audit module identifies weaknesses so customers can address these formally within the Corrective Action Request module and then take the necessary steps to identify preventative actions to ensure that they are not repeated. EnterpriseIQ also allows the setup of key performance indicators that can be used to track metrics associated with the quality management improvements. 58. When there are Non-Conformances, determine the cause, take corrective measures to repair and then follow up to ensure the repair was permanent. Determine ahead of time what will be done if corrective actions are not effective. (8.5.2) The EnterpriseIQ Corrective Action module was designed specifically to track and document the corrective action process. Additionally, the Failure Mode and Effect Analysis (FMEA) module can be used to assess and document potential problems during the design phase of products. 59. Ensure the corrective actions involving suppliers are flowed down to the suppliers. (8.5.2)

9 The EnterpriseIQ Corrective Action module allows suppliers (and customers) to be part of the corrective action workflows. This ensures that the suppliers are part of the corrective action process and resolution is communicated to and signed off on by the suppliers. 60. Determine where problems could happen and prevent them from happening. (8.5.3) The intent behind the EnterpriseIQ Quality modules (APQP, FMEA, Control Plans, MRB, Engineering Change Control, CAR, Deviation, PPAP & Audits) and the Product Lifecycle Management and Document Control Modules is to ensure that the entire quality process is evaluated thoroughly from the design stage through production and support to ensure that all quality issues are addressed, rectified and documented.