QUALITY SYSTEMS DEVELOPMENT

QUALITY SYSTEMS DEVELOPMENT

OBR Engineering is responsible to plan, organize and direct activities to ensure quality standards are maintained. OBR Engineering will optimize activities that have an effect on the quality of products produced. OBR Engineering assures products meet requirements per specifications, customer requirements, and associated drawings.

Call or email OBR Optimization Engineering and let OBR customize your Quality Systems needs and considerations. OBR Engineering will deliver your Quality Development Package! (424) 241-0290

Deliverables:

  • Assist onsite team with Quality Management System.
  • Develop and improve standards and procedures.
  • Ensure ISO/AS9100/AS9100 compliance with Quality Management System.
  • Verify accuracy and performance of products with Failure Analysis Report.
  • Analyze failures, determine root cause and initiate corrective action.
  • Troubleshoot inaccuracies or problems and share results and recommendations with management.
  • Ensure requirements are being met per functional specifications.
  • Perform Quality Assurance tasks to assure developed products meet requirements.
  • Perform supplier qualification, visits, and audits.
  • Utilize Customer (Internal or External) feedback as an input to drive continual improvement.
  • Verify and validate information flowing to suppliers and validate that the suppliers are responding to requirements.
  • Implement administer and maintain Quality Management System through design, development and production phases on Engineering/Production programs.
  • Interfaces with Program Management, Engineering, and Operations in program lifecycle.
  • Define, analyze, manage, and improve program metrics.
  • Review and perform first article inspection.
  • Review program documentation (drawings, assemblies, procedures, reports, etc.)
  • Validation activities, including IQ, OQ, PQ.
  • Measurement system analysis, gage R&R, and measurement correlation.
  • Manage and perform activities associated with CAPA, Complaints, Non-Conforming Materials, Inspection, and Calibration.

  • Embed Systems Excellence

  • Quality Standard ISO 9001/AS9100/AS9110

  • Total Client Satisfaction

  • Attention to Detail

  • Quality Standard  ISO 13485

  • Global Quality Systems Partner of Choice!

AUDIT & COMPLIANCE

OBR Engineering is responsible to prepare regulated systems and documentation for successful completion of internal and external audits.

Call or email OBR Optimization Engineering and let OBR develop your Quality Audit and Compliance preparation. OBR Engineering will deliver to you a Successful Audit! (424) 241-0290

Deliverables:

  • Audit practices and records of manufacturing plant to ensure compliance.
  • Prepare systems and documentation for internal and external audits.
  • NADCAP, ISO 9001, AS9100, Medical Device ISO 13485, Mil-Specs, ITAR, Aerospace specification, metallurgy heat treating and plating.
  • NDT procedures and specifications.
  • Audit compliance by target user groups with published policy and procedure and recommend appropriate improvements or corrective action as necessary.
  • Prepare internal reports and summaries on incidents of non-compliance with relevant legal, regulatory and policy requirements.
  • Conduct periodic needs-analysis for new or revised policies and procedures, and suggest appropriate solutions, including design of training materials.
  • Ensure compliance with established internal control procedures by examining records, reports, operating practices, and documentation.
  • Complete audit work papers by documenting audit tests and findings.
  • Maintain internal control systems by updating audit programs and recommending new policies and procedures.
  • Communicate audit findings by preparing a final report; discussing findings with auditees.
  • Prepare special audit and control reports by collecting, analyzing, and summarizing operating information and trends.
  • Contribute to team effort by accomplishing related results as needed.

SAFETY REGULATION

OBR Engineering is responsible to review, evaluate, and analyze work environments and design/implement programs and procedures to control, eliminate, and prevent disease or injury caused by mechanical, physical, or ergonomic factors. and enforce adherence to laws and regulations governing the health and safety of individuals.

Call or email OBR Optimization Engineering and start your Safety Regulation review! OBR Engineering will deliver a Safety Development Optimization Package customized for Your Business! (424) 241-0290

Deliverables:

  • Develop and implement Safety processes including emergency preparedness and fire protection, safety risk assessments and safe working procedures, hazardous waste management, training, ergonomics, and crisis management
  • Develops training plans and specific in-house training for employees and contractors on Safety topics and local rules as well as on the job-specific risks.
  • Develop, revise, and implement Safety programs to determine areas of plant impact, containment, labeling, in-plant transportation and storage, waste.
  • Identify vendor support services, training programs, record keeping and reporting, and material and equipment requirement.
  • Lead implementation and training of a facility-wide Lock-out Tag-out program
  • Lead internal Incident Investigations to find continuous improvement opportunities either in work practices or work conditions with the use of solid root cause analysis.
  • Reviews injury/illness and non-injury incident investigation reports and follow-up as necessary.
  • Responsible for Safety Data Sheets (SDS) collection and internal distribution with personnel, to ensure that facility SDSs are managed in compliance with relevant regulations.
  • Sample waste streams and various media (solids and liquids) and prepares samples for delivery, and analysis at contracted lab.
  • Advise and provides counsel on federal and state regulations covering hazardous chemical communication programs (HazCom), confined space entry, personal protective equipment, Lockout Tag Out, electrical safety, fire prevention, machine guarding materials handling and storage, excavations, ladders and stairways, welding and cutting, and work zone safety.
  • Perform inspections and incident investigations, conducts audits, prepares reports, handles facility permitting and interacts with regulatory agencies, and vendors.
  • Recommend changes to work conditions and procedures to improve the work environment and comply with all health and safety regulations.
  • Implement risk management activities necessary to ensure the company maintains a safe work environment for employees.
  • Performs and coordinates job hazard analysis (JHAs)
  • Administers the safety incentive program.
  • Maintains OSHA LOG 300 and ensures annual postings at each work location.
  • Ensure compliance with company programs and Federal/State occupational safety and health regulations. Advises manufacturing plant and corporate staff of regulatory changes with which the plant must comply.

Individual commitment to a group effort – that is what makes a team work, a company work, a society work, a civilization work! Vince Lombardi