D000356 Control Of Production Processes

5 Questions | Total Attempts: 669

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Assessment Quizzes & Trivia

Competency Assessment


Questions and Answers
  • 1. 
    When might Non-qualified equipment might be present in a production area for the purpose of collecting data to conduct the required equipment qualification?
    • A. 

      Any DR created for use with the non-qualified equipment must clearly identify the non-qualified equipment and clearly describe how this equipment is to be used.

    • B. 

      D000324 - "Form No. 583: Non Qualified 1Alert" is to be prominently displayed on any non-qualified equipment that might be present in a production work area, and contains the following information: • EQ # and equipment name (e.g., THC Crimper, Gen 3 CK Mini Staker, …) • Purpose / function of the equipment (e.g., crimp curved handles, stake HA’s in CK Mini), • Affected product line. • Personnel responsible for the equipment • EXP # (optional)

    • C. 

      All of the above

  • 2. 
    Cross functional teams are responsible for developing Shop Travelers and BOMs for each sub-assembly or finished product.
    • A. 

      True

    • B. 

      False

  • 3. 
    What is the importance of process controls?
    • A. 

      To ensure the devices meet approved specifications

    • B. 

      To make the job take longer

    • C. 

      To prevent non-conformances

    • D. 

      Both A and C

  • 4. 
    Process validations are important in assuring that processes will consistently meet quality standards. Process validations consist of 3 steps and must be performed in a specific sequence. Which of the following is correct?
    • A. 

      OQ, IQ, PQ

    • B. 

      IQ, OQ, PQ

    • C. 

      PDQ, IQ, OQ

    • D. 

      PDQ, PV, XYZ

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