Ustanawianie wymagań jakościowych

Define critical-to-quality characteristics

Określanie cech kluczowych dla zarządzania jakością korporacyjną. Przekształcanie wymagań klientów w mierzalne standardy jakości.

Outlining characteristics crucial for managing enterprise quality. Translate broad customer needs into specific, actionable, measurable performance requirements. Define the key measurable characteristics of key products and processes.

Define preventive quality activities

Identyfikowanie luk w wymaganiach klientów i określanie, czy organizacja spełnia te wymagania w zakresie jakości.

Identifying gaps in customer requirements and determining whether the gap will be mitigated through preventive Quality activities or deemed as acceptable risk. The goal of any preventive quality activities is to create provisions to prevent, control, or reduce the risk of not meeting the CtQCs. In addition, any standard methodology that will be used to design or conduct preventive Quality activities are defined and documented.

Develop quality controls

Opracowywanie mechanizmów kontroli jakości korporacyjnej. Definiowanie standardów i procedur zapewniania jakości w organizacji.

Developing controls for managing the quality of enterprise. Define the process steps for quality controls and the sampling plan. Identify the tools and methods to measure quality. Define the competencies required.

Prove capability to assess compliance with requirements

Demonstrowanie zdolności i możliwości potwierdzenia i spełnienia wymagań jakościowych określonych przez klientów i regulatora.

Demonstrating the ability and capability to confirm and fulfill the quality requirements in front of customers, managers, employees, board members, associations, regulatory bodies, and creditors. Leverage tools and techniques such as process behavior or control charts, statistical process control, measurement system analysis, gage calibration management, and process capability analysis.

Finalize quality plan

Ustanawianie sposobu osiągania krytycznych dla jakości charakterystyk produktów i usług w ramach procesów organizacji.

Establishing how the critical-to-quality characteristics will be achieved, controlled, ensured, and managed throughout the lifecycle of a product/service. Address quality requirements and critical-to-quality characteristics. Conduct a preventive quality assessment. Describe how to verify the product/service, verification criteria, and response to nonconformance. Keep records to demonstrate conformity.