GMP Compliance Preparation - Conduct Good Manufacturing Practices (GMP) gap assessment for a retail company seeking to be qualified to provide products to a major United States consumer/neighborhood wholesale company. Supported client during the GMP audit and assisted with question & answer guidance and selection of objective evidence to present. Client was approved and qualified.
AS9100 Internal Audits and Supplier 2nd Party Audits - Conduct AS9100 internal audits for public Fortune 500 company serving OEM and Tier 1 customers on the 737 series aircraft platform. Responsible for conducting audits in accordance with an an annual plan covering design and development, specialty manufacturing processes, customer service, contract management, quality, continuous improvement and executive leadership. This client was pleased with CAMBIO's auditing services and expanded our scope of service to include AS9100 2nd party audits at their critical suppliers.
AS9100 QMS Development Assist three Southern California aerospace suppliers achieve AS9100 in under 12 months. Conduct AS9100 gap assessments, train employees at all levels on AS9100 requirements and expectations, assist top management with choosing quality objectives and conducting initial management review meetings, and support Stage 1 and Stage 2 registrar audits. Expand usage of clients' existing ERP software and workflows to adapt to AS9100 requirements and avoid paper-based processes.
Warehouse Physical Inventory Engaged with Southern California direct to consumer product company to provide project management services and guidance for their first physical inventory at two warehouse locations.
AS9100 Stage 1 and Stage 2 Preparation - A specialized electronics assembly business was seeking AS 9100 compliance in order to qualify for a large contract. CAMBIO helped this client define their key business processes, establish metrics, define record retention requirements and assisted them pass their Stage 1 (no findings) and Stage 2 audit.
Cybersecurity Reports - Unfortunately, cybersecurity risks are increasing for manufacturing and associated service businesses. CAMBIO can assist our clients plan and implement a straight-forward cybersecurity program that covers all devices including servers, desktops, laptops, and mobile devices. Should an incident occur, CAMBIO can also assist clients with a confidential root-cause investigation and incident report, with recommended preventive actions.
PPAP Preparation - The Production Part Approval Process (PPAP) is a series of customer deliverables that must be prepared, traditionally for automotive customers, that demonstrates a product meets all the requirements of the customer drawing and process controls. We prepare all necessary documentation including First Article Inspection, Process Flow Chart, Process FMEA, Process Control Plan, initial process capability report (CPK etc), Part Submission Warrant (PSW) and other required documents. This product was a high volume, tight tolerance, insert molded product produced with a multi-cavity injection molding tool. The schedule was aggressive to satisfy customer production timing and CAMBIO's experienced mechanical inspector performed all physical dimensions for the client, and all PPAP documents were prepared by our experienced engineering associate.
Disaster Recovery Plan - Conduct a current state review of the IT disaster recovery plan for a global automotive manufacturer. Document recovery plan, flow chart current processes, gather key internal and external contact information, and provide recommendations for increased resilience.
EDI Software Selection, Implementation, and Training - Select EDI software for global automotive manufacturer. Research EDI software market offerings, select best software, oversee implementation, document training manual, and train end users at two US-based and one international production site.
AS9100 Internal Audits - Conduct internal audits for an established aerospace electronics supplier looking to get a "fresh eyes" perspective on their AS 9100 compliance, continuous improvement opportunities, and better integration of their QMS with their business's strategic direction.
Document Scanning and Searchable Database - Implement an ITAR compliant, on-site scanning process for client's supplier receipt records, manufacturing build work-orders, FAA 8130 reccords, AS 9102 first articles inspection reports, and packing slip records. Create web-based searchable archive so all stakeholders (inspectors, QA, contract administrators, buyers, accounting) can quickly retrieve records. Scanning volume of ~100,000 pages monthly.
Virtual Inspection Portal - Reduce document related incoming inspection rejects at major aerospace supplier by allowing suppliers to first upload their certificate of conformance and certification package into an online portal.
Web Based Barcode Label Creator - Implement a web-based barcode label generator for suppliers to quickly enter shipment information, create a barcode label meeting customer specifications, and provide advanced shipment notice to customer that the supplier's parts are in transit. Centralized label design allows customer to tweak the barcode design and layout instantly, without changing the suppliers' data entry methods.
AS9100 Rev C to AS9100 Rev D Gap Analysis - Lead the gap analysis and transition plan for tier 1 aerospace company. Completed gap analysis, recommended actions report, internal audits all within a month of their recertification audit. Client received AS 9100 Rev D/ISO9001:2015 certification upgrade with only minor findings.
ISO9001:2015 Gap Analysis and Certification Support - Assist laboratory equipment manufacturer upgrade to ISO 9001 version 2015. Conduct gap analysis, train top management on new concepts such as context of the organization, risk based thinking, stakeholder considerations, and quality objectives. ISO 9001 certification was awarded after a successful Stage 1 and Stage 2 audit.
Major League Baseball Team Intranet Design - Design and implement an Intranet portal for a world-series champion Major League Baseball franchise. Work with internal graphics teams, branding and conduct feature reviews with all cross-functional departments including Human Resources, IT, Sales, Operations and Security.
Supplier Portal Design and Hosting - Design and host a supplier communication portal for a Fortune 500 client company. Portal includes document template downloads, supplier communications, DFARS certificate applet, and key contact information to aid suppliers in on-time delivery and quality expectations.