For the Medical Device Industry

Transcription

1 For the Medical Device Industry

2 SOLUMINA SQA SOLUTIONS Figure 1 SUPPLIER QUALITY ASSURANCE Business Process Improvement Results Shared by Current Users Reduce Inventory in Receiving Inspection Solumina Supplier Quality Assurance system enables a new systematic and dynamic approach for medical device manufacturers to manage quality with their suppliers. Solumina provides a complete paperless system for defining, managing, communicating and verifying product specifications and requirements with suppliers. Quality can be managed at the supplier efficiently down to the characteristic level with processes that parallel the internal processes. Quality Engineers plan product and inspection specifications, which include product characteristics, tolerances, and rules for sampling, oversight and audits, and First Article Inspection (FAI) requirements. Minimize Inventory in Receiving Inspection Minimize the Need for Third-Party Contract Solumina s collaborative quality approach enables Inspection more inspections to be performed at the supplier Solumina provides the ability to remotely review site via the web instead of inspecting after receiving. Inventory items in receiving inspection are surements, check lists and certifications. Inspec- and approve source inspection data including mea- minimized. Products can ship directly from the supplier to work-in-process at the plant based on the site by customer, supplier, or third party contractions and audits can be performed at the supplier supplier s quality rating for the specific part and the tors as specified by the quality manager for each rules established by quality managers. supplier and part. The application provides a systematic way to manage the oversight of source inspections performed by suppliers in order to minimize the need for third party contract inspection at the supplier s facility. Reduce Cycle Time for Quality issues are identified earlier at the supplier Supplier Issue Resolution site and corrected before shipment of goods is authorized. Quality issues that escape and are found downstream during the assembly process, have a greater impact on the supplier s metrics, and trigger containment and Corrective Action. Reduce Admin and Contract Inspectors Improve Supplier Performance 1

3 Eliminate Manual Management Tasks Receiving inspection, source inspection and suppliers can perform all necessary transactions via the web. But Solumina s Supplier Quality Assurance system does more than deliver forms to suppliers via a web portal. The system dynamically generates inspection and audit requirements for each PO line item based on the most recent history for the specific part and for the specific supplier. As supplier quality increases, the system relaxes oversight requirements based on pre-established inspection oversight rules for different types of parts. Conversely, the system tightens inspections and oversight as defects are found either at the supplier location, or downstream during the assembly process. The automation of oversight rules eliminates the need to manually manage intervention and ensures that all suppliers are managed consistently. Users are stepped through check lists and data collections, which can be configured to branch based on user answers. In-process recorded measurements and observations trigger instant feedback on out-of-tolerance and out-of-control conditions. Reduce Cycle Time to Resolve Supplier Issues Users can document Discrepancies at the source, at Receiving, or when an escape is found on the shop floor. Solumina includes a completely integrated discrepancy documentation, classification, disposition, and Corrective Action system. Every manager, engineer and production mechanic strives for zero defects, but the reality is that discrepancies and defects happen. Real-time communication between suppliers and buyers make it possible to react quickly to disposition issues when they arise on the shop floor. The Solumina system continuously monitors quality based on inspection results and provides a methodology to continuously improve quality. When repeat escapes are found, the system initiates containment and Corrective Actions. Improve Supplier Performance Supplier performance management is critical to controlling production costs, reducing variance, and protecting the quality standards associated with the brand name. Solumina provides the capability to query real-time supplier status, constraints, and history records for all processes and activities related to product quality and production history. Graphs and reports include inspections, supplier ratings, DPPM, and discrepancies. Solumina enables a self-managed quality path for suppliers, which increases awareness and ownership of process strengths and weaknesses. The collaborative quality system provides the supplier with an easy to use tool to help diagnose which processes need the most attention. Solumina Supplier Quality Assurance includes these features: Configuration-managed product characteristics, inspection requirements, and rules for sampling, oversight and audit Generative Inspection Planning Sampling and oversight plans with rules for automatic sample size adjustments based on each supplier s part history Records for all processes and activities related to product quality Real-time communication among suppliers, buyers and quality managers Two-way communication for inspection results, supplier rating, DPPM graphs, discrepancies and corrective action Dynamic inspection requirements for each Purchase Order based on supplier performance Online Verifications and Characteristic Data Collection Discrepancy report, Issue/Defect Containment Holds and Corrective Action Requests Quality analysis tools that provide a self-managed path for suppliers Strict rules for compliances with First Article Inspection requirements Gradual transition of more component inspections to the supplier 2

4 SUPPLIER QUALITY ASSURANCE SOLUMINA SQA FEATURES Solumina s Supplier Quality Assurance functionality can be used by itself or coupled with other Solumina quality management functions used to manage internal production operations. The Solumina suite of software solutions provides a comprehensive quality management solution for your organization. Product Specifications Inspection Planning Solumina provides organization and management Solumina provides a central location for the authoring tools to develop a library of product specifications, and maintenance of inspection requirements process specifications, inspection requirements, for product key characteristics and verifications and rules for sampling, oversight and audit. These for process requirements including handling, labeling dynamic inspection and verification requirements and packaging. Characteristic measurement are dispatched over the web to the supplier site for requirements include upper and lower spec limits each purchase order line item. All inspection data and sampling rules. Inspection and verification collection is recorded in Solumina and can be used specifications can be set at hierarchal levels with to determine which areas need to be enhanced, and the following override capabilities: which suppliers require additional oversight or Standard Requirement Group Corrective Action. Part Family Specific Part Number Specific Supplier/Part Number Specific Sampling Plans Each measurement or observation characteristic is assigned a sampling plan that determines the frequency and sample size for each inspection. For example, characteristics that are considered critical can cause 100% of all associated parts to be sampled and inspected. Characteristics considered minor can cause a smaller percentage of parts to be sampled and inspected. Each sampling plan can optionally include switching logic that defines rules for automatically switching to a tighter or more relaxed sampling plan based on recorded failure history. Inspection items or characteristics with no issues gradually receive less attention while trouble spots receive more scrutiny. Figure 2 Verifications and Characteristics Tied to Requirement, Part or Supplier Part 3

5 Process Control The process control features assure that all verifications are performed and documented in the prescribed order, that inspectors have the proper certifications to perform certain inspections and data collections, and that the latest characteristic measurement and sampling requirements are applied including the type of gauge required. Purchase Order Information When an inspector logs onto Solumina, all relevant open purchase-order line items appear in a dispatch list. On command, each purchase order generates a corresponding Inspection Order whose instructions are based on current characteristic, inspection, and sampling requirements. All requirements are in full view including specification limits, criteria, and inspection method details. Online Verification and Data Collection The Inspection Order includes all characteristic data collections that must be performed. The user interface makes data entry easy by prompting the inspector for each check list item, observation, and measurement required. When inspectors log on to the system, they quickly return to where they left off in the Inspection Order. Solumina lets the inspector know what data collections remain before the inspection can be completed. The system also alerts when entered values are out of range. Optimized Inspection and Audit Oversight Certain suppliers will require more inspection oversight than others. Solumina randomly determines which Inspection Orders will be selected for overinspection based on each supplier s historical and recent quality performance. The system ensures that the over-inspection is performed by an Inspector different from the one performing the primary inspection. First Article Inspection When Purchase Orders indicate that there is an open First Article Inspection (FAI) or FAI Delta requirement, Solumina ensures that the next Inspection Order is flagged accordingly and all the FAI requirements must be completed in full before any units can be shipped to the buyer. Figure 3 Verification Requirements at the Source, Receiving or Both Figure 4 Supplier Quality Performance Metrics Include DPPM 4

6 Figure 5 Supplier Portal for Two- Way Communication with Suppliers via the Web Supplier Quality Analysis Tools Supplier performance management is critical to managing production costs, reducing variance, and protecting the quality standards associated with brand names. In Solumina, each supplier s performance is tracked consistently with full visibility of all supplier-induced issues and defects found during inspection at the source, or as an escape downstream in the manufacturing process. Solumina displays quality performance metrics in easy-toread charts and reports that can drill down all the way to the specific Purchaser Order and inspection. Suppliers with a high defect or failure rate are highlighted. Discrepancies Discrepancy and defect reporting are fully integrated and initiated directly from an Inspection Order. The inspector is required to initiate a Discrepancy report if any of the characteristic data collections are rejected or out of limits. Discrepancies are automatically routed to the appropriate personnel. Discrepancies caused by a supplier will affect the supplier s performance rating. The disposition, review and approval workflow is configured to handle complex routing requirements for different types of discrepancies. Communications further complement the process, documenting review and discussion threads. Discrepancies and defects are classified by responsible processes, defect types, symptom types and cause types. Analysis of defect classifications provides the basis for needed Corrective Actions. A unit s disposition can include instructions to rework, repair or scrap the unit. A defective installed component or subassembly can be fixed in place or removed. The defect moves with the removed component. The removal history stays with the assembly. Benefits: Improved component parts quality Fewer quality escapes Least inventory in receiving inspection Minimum third party contract source inspection Lower sourcing and warranty administrative costs Reduced inspection and audit oversight cost Quicker issue disposition and corrective action Increased supplier ownership of process strengths and weaknesses 5

7 Quality Suspect and Defect Containment Defect containment Holds prevent further shipment of suspect parts without verified Corrective Action, over inspection, or explicit approval. Alerts are immediately placed on all affected Inspection Orders. Visibility of Holds is never lost throughout the process. Solumina includes various types of Holds including red decal Holds which identify an item that is authorized to ship because an issue cannot be resolved at the supplier site. Corrective Action Holds are also automatically placed on any Inspection Order for parts that have pending Corrective Actions with the supplier. The Hold can be lifted by the buyer or quality manager to approve shipping even though Corrective Action is still pending. Corrective and Preventive Action Solumina s closed-loop Corrective and Preventive Action (CAPA) process manages investigation, action items and verifications. Each Corrective Action is a project coordinated by a facilitator responsible for following up on investigation and action items until there is an agreement and commitment on resolutions. Corrective Action can be requested from either discrepancies or Corrective Action Requests. Corrective Action Requests are created to track process improvement suggestions or issues like recurring defects, or customer satisfaction concerns. Several requests can be linked to a single Corrective Action. The Corrective Action tracks investigation, rootcause analysis, and resolution commitments. Action items are routed according to the responsibility identified. The root-cause analysis process can be escalated according to the severity of the issue and more participants can be added to the investigation team from multiple disciplines. The Corrective Action process is not complete until implementation is verified and proven effective. Solumina allows scheduling of implementation verification tasks according to the commitment dates. Containment processes are tied to the Corrective Action until subsequent effectiveness verification is recorded to verify the success of the prescribed solutions. Figure 6 Defect Containment is Automatically Flagged until Correction Action is Verified Figure 7 Corrective Action Initiated from Discrepancy Report 6

8 Solumina is an Operations Process Management (OPM) software suite that manages work and quality processes for the manufacturing and MRO (Maintenance, Repair and Overhaul) of highly engineered medical device products. Solumina functional modules include Process Planning (CAPP), Manufacturing Execution System (MES), Quality Management System (QMS, CAPA), Supplier Quality Assurance (SQA), and Maintenance, Repair and Overhaul (MRO) in one integrated system. Solumina is uniquely designed to manage the product life cycle, beginning with product and process quality specifications into the supply chain, continuing with the manufacture of component parts, the assembly of product, and the aftermarket service of each product unit until retirement. Solumina functional modules include: Solumina Operations Process Management for the Medical Device Manufacturer Manufacturing Execution System Quality Assurance System (QA, Discrepancies, CAPA) Solumina Operations Process Management for Medical Device Maintenance, Repair and Overhaul Maintenance Requirements Planning Maintenance Task Planning Maintenance Online Execution, Non-routine Execution Solumina Supplier Quality Assurance for the Medical Device Manufacturer Supplier Inspection Planning Receiving and Source Inspection Discrepancy Reporting and Corrective Actions Portola Pkwy Suite 300 Foothill Ranch, CA P: F: Copyright 2015 ibaset. All Rights Reserved.