Build a Supportive Quality Organization

"Coming together is a beginning. Keeping together is progress. Working together is success." ~Henry Ford

Building a new quality organization or rebuilding an existing team, for me, is part of the fun of being a Quality Manager. Having good, motivated, driven team members is an important start. Evolving the team into roles and responsibilities to support your greater organization doesn't ever end as a healthy company will grow, change, evolve over time.

In general, there are key elements requiring attention in a quality organization.

The medical device quality system regulations point to sub-systems in the quality management system. These subsystems are:

• Management System

• Design Controls

• Production & Process Controls

• CAPA System

And this model translates across quality systems across industries.

The organizations I have built have had streams, if you will. Depending on the size of the greater organization, the quality team may have several talents working in each stream/subsystem or one team member covering 2 or more.

For the purposes of this blog, I will take a very general approach in modeling a quality organization.

Management System: As Quality Manager, I typically take hands-on ownership of the Management System (QMS) together with a talented Quality Assurance Specialist or two. This stream includes the process-based approach, TQM-focused QMS, KPIs and active risk management of processes making up the QMS, establishing good and effective Quality Management Reviews to ensure oversight by top management. Management System also encompasses training (& competence required by ISO), document control and the very important and what should be risk-based internal audits program.

Design Controls: This stream should be led and owned by a Design and Development team, actively supported by talented design quality engineers (DQEs) who have a good understanding of the product lifecycle from studying the feasibility of a design, to user needs and design outputs, to verification and validation of the design, to the transfer of the design into manufacturing.

Design Quality Engineers establish the design and risk management deliverables through the design lifecycle, collaborate with the design department and review and approve the design as it moves through the process.

Design Engineers identify the design essentials or specific requirements that are related to the proper functioning of the final product. These translate to critical quality attributes that are monitored and assured through design and into manufacturing.

For certain industries including medical device, risk management begins in the early phase of design and evolves with the design with constant consideration and mitigations to remove or reduce risk, hazards and to improve safety in the design. Design Failure Modes Effects Analysis (DFMEA) are developed on the design and a hazard analysis is performed, both as content in the Risk Management File. The risks considered include risk to the user, the operators and hazards to the patient, considerations of overall safety, in the example of the medical device. Risk also considers the risk of not properly producing the product as risk continues through design transfer into manufacturing.

Design Quality Engineers will follow risk through supply chain and to the field, keeping the risk management file as a living document. A key element from the risk perspective of the design transfer into manufacturing is developing the Process Failure Modes Effects Analysis (PFMEA), in addition to the development of control plans to control risk and ensure focus on the identified design essentials. An output of product surveillance and product/process monitoring is updates to the risk management file and continuous efforts to reduce risk, hazards, and to improve safety.

Production & Process Controls (P&PC): The larger manufacturing organization made up of talents including manufacturing engineers &/or process engineers, owns P&PC. And the quality organization supplies talented QEs to this area.

This stream picks up at the transfer of the design into manufacturing, ensuring that risks are understood, documented, under regular review for mitigation, and are translated into process control plans.

Manufacturing/Process engineers develop the process control plans as part of the design transfer activities, encompassing controls at incoming inspection through in process inspection to final inspection. And the P&PC QE engages, supports, reviews and approves once written.

Once the process is under control, the continuous improvement activities begin. And with improvements comes change and change control rigor. Depending on the scope of the change, the P&PC QEs may need to go back to the Design Control QEs for support of changes to the design and re-verification/re-validation where needed.

Under P&PC, we have Supplier Quality Engineers (SQEs) working with procurement and suppliers to ensure product is received to the quality and specification expected by the design and that suppliers remain healthy and in control.

Nonconforming products management, though defined in the CAPA Subsystem, are addressed in practical terms typically by P&PC QEs. This includes decisions on product disposition, facilitation of rework and more.

Final release of product should be conducted by P&PC QEs who review to ensure change orders, NCRs and CAPAs are properly mitigated prior to approving product for shipment to customers.

CAPA subsystem includes establishing framework for non-conforming product management, escalations of nonconformances to correction & preventive action (CAPA), complaints management, product surveillance and continuous improvement (managed through CAPA). And the overall program can be owned by talented Quality Assurance specialists who will pull in QEs for input, review and approvals based on the established workflows.

Here is a visual of a typical quality organization:

QA Organization

This can be scaled in size and quantity of staffing based on the needs of the organization.