How our programs work

Plan: We help you determine the best approach(s) to establishing the customized Product Safety Risk Management Program required to assure all risk management requirements are met, and compliance is sustained.  .

Do: We not only provide guidance on how to execute the Product Safety Risk Management Program, we participate in the execution of the Product Safety Risk Management activities. We use our own Program Management group to ensure requirements are effectively communicated and actions are properly performed.  Please note that we do not do it all for you, because this would not help the organization in the long run, and it would not be a cost effective solution.

Check: Milestones and Planned Systemic Reviews are essential to assuring that the Product Safety Risk Management Program does not run amuck. We use Program Management to help the organization reach miles stones and check performance against time and budget objectives.

Act: Tactical adjustments will be frequently required; it is just part of the process. Product Safety Risk Management is a complex undertaking, and so we must all be prepared to act as soon as a deficiency in execution is identified. We are experts at this, and we believe this is one of the significant differences between QPC Services and most of our competitors.

In addition to the Plan/Do/Check/Act core model, we tie our success to the success of our clients. We establish meaningful milestones with measurable requirements. We prize efficiency as well as effectiveness, and we place a significant portion of our billing on bonuses for milestone completion with quality deliverable​s that are on time or sooner. In this way, be believe, we allow our clients to pay for actual performance, not promised performance. We become a part of your team, and we stay ‘in the boat” with you throughout the journey.

Our process

 

PROCESS PHASES

Plan-Do-Check-Act

Plan-Do-Check-Act

Plan-Do-Check-Act

Plan-Do-Check-Act

Plan-Do-Check-Act

CONCEPT DEVELOPMENT PROGRAM DESIGN DETAILED DESIGN VERIFICATION AND VALIDATION POST MARKET

PROCESS COMPONENTS

Gap Assessment to determine what you already have, and what additional program elements you requireNote:  This process may be modified as a result of the Gap Assessment Hazard Scenarios refined Detailed Design Risk Assessments completed Verification  and Validation of the effectiveness of established controls Product Performance Monitoring
Product Safety Risk Management Planning Mitigation Strategies refined and incorporated Other applicable Controls identified Risk Management Report Design Change
Hazard Identification Usability Risks assessed Critical Characteristics identified
Concept Risk Assessment Essential Performance Requirements defined Process Risks and associated Controls established
Identification of Detailed Design Risk Assessmentsthat will be needed Validation of the effectiveness of established controls

Some of our past risk management clients:
  • Small medical device manufacturers who were at risk of going out of businesses due to quality/regulatory problems, who needed to established Product Safety Risk Management Program as part of their Quality Management System Remediation Actions.
  • Specification developers that design a device and have it manufactured by another company.​
  • Key suppliers for large medical device manufacturer.

A set of design, process, usability Failure Mode and Effects Analysis (FMEA) does not constitute a proper Product Safety Risk Management Program.  All companies face product issues once their products are marketed.  A well-established Product Safety Risk Management Program goes a long way to ensure the performance issues, and the required remediation actions are minimized.

What makes ms different

QPC Services will provide you a dedicated Product Safety Risk Management expert committed to your organization who walks you through the entire process. Additionally, we also build a t roadmap by which progress and performance will be measured. If you have any doubt about Product Safety Risk Management Program, the time to act is now.

Our brand promise

We truly believe we provide the best consulting services in Quality Management System / cGMP Remediation, Regulatory Applications, and Product Safety Risk Management.  In everything we do we bring relief and results to our customers so they can get back to business knowing their Quality Management System / cGMP Compliance, Regulatory Applications, and Product Safety Risk Management are being taken care of by the best team possible.

To find out how we can help your business, contact us today for a free, no-obligation consultation.