Process Qualification Checklist

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1. Development Qualification:

• Product Development Process:
  • Qualification of personnel to be engaged;
  • Sub-process for idea generation and screening out the unsound ones:
    • Collection and systematization of suggestions;
    • Analyzing market requirements;
    • Brainstorming with the staff;
    • Using mind maps, etc;
  • Translation of market requirements and disembodied ideas into more definite conceptions;
  • Developing & testing the conceptions, and their further feasibility studying;
  • Documenting the results of the process: the most sound conceptions should go further;
  • Engaging the administrative resources to make a decision on the proposed conceptions;
  • Projecting the product production costs, quality and pricing to customers;
• Product Development Performance Analysis:
  • Controlling the quality and correctness of sub-processes and their organization;
  • Checking suitability to corporate policies, strategies and interests;
  • Appropriateness of documentations;

2.  Engineering and Design Qualification:

• Product Engineering Process:
  • Qualification of personnel to be engaged;
  • Elaboration of proposed conceptions down to a necessary level of detail;
  • Making the conceptions to be developed and engineered into the terms of practical design;
  • Justification of possibility to produce products at the projected cost and quality;
  • Determination of feasibility to produce the product within given facilities and resources;
• Pre-released Product Performance Analysis:
  • Virtual and mock-up modeling;
  • Production of a sample product (prototyping);
  • Testing as necessary;

3. Manufacturing Qualification:

• Manufacturing Qualifications:
  • Product specifications for production;
  • Personnel to be engaged;
  • Equipment and tools to be used;
  • Working process to be applied;
  • Raw materials to be utilized;
  • Suppliers to be contracted;
• Ready Product Performance Analysis:
  • Workability;
  • Effectiveness;
  • Durability;
  • Safety;
  • Configuration;
  • Profitability;
• Qualification of Shipment to Customers:
  • Optimality of transportation ...

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