Medical Program Management

Advanced Product Quality Planning (APQP):

Southmedic’s product development process controls product design and development projects. Our approach assures that communication with customers and suppliers is clear and allows us to facilitate a smooth and timely implementation.

The Advanced Product Quality Planning process consists of 4 phases and 5 major activities along with ongoing feedback assessment and corrective action as shown below.

program_management_chart

APQP involves 7 key elements:

  • Understand customer needs. This is done using voice of the customer techniques to determine customer needs and using quality function deployment to organize those needs and translate them into product characteristics/requirements.
  • Proactive feedback and corrective action. The advance quality planning process provides feedback from other similar projects with the objective of developing counter-measures on the current project. Other mechanisms with verification and validation, design reviews, analyses of customer feedback and warranty data also satisfy this objective.
  • Design within process capabilities. This objective assumes that the company has brought processes under statistical control, has determined its process capability and has communicated it process capability to its development personnel. Once this is done, product development personnel need to formally determine that critical or special characteristics are within the enterprise’s process capability or initiate action to improve the process or acquire more capable equipment.
  • Analyze and mitigate failure modes. This is done using techniques such as failure mode and effects analysis or anticipatory failure analysis.
  • Verification and validation. Design verification is testing to assure that the design outputs meet design input requirements. Design verification may include activities such as: design reviews, performing alternate calculations, understanding tests and demonstrations, and review of design documents before release. Validation is the process of ensuring that the product conforms to defined user needs, requirements, and/or specifications under defined operating conditions. Design validation is performed on the final product design with parts that meet design intent. Production validation is performed on the final product design with parts that meet design intent produced production processes intended for normal production.
  • Design reviews. Design reviews are formal reviews conducted during the development of a product to assure that the requirements, concept, product or process satisfies the requirements of that stage of development, the issues are understood, the risks are being managed, and there is a good business case for development. Typical design reviews include: requirements review, concept/preliminary design review, final design review, and a production readiness/launch review.
  • Control special/critical characteristics. Special/critical characteristics are identified through quality function deployment or other similar structured method. Once these characteristics are understood, and there is an assessment that the process is capable of meeting these characteristics (and their tolerances), the process must be controlled. A control plan is prepared to indicate how this will be achieved. Control Plans provide a written description of systems used in minimizing product and process variation including equipment, equipment set-up, processing, tooling, fixtures, material, preventative maintenance and methods.