Product Change Management Overview

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Questions and Answers

Which term refers to the imperfection created when an air bubble is trapped in a material during a manufacturing process?

  • Foil crack
  • Air bubble (correct)
  • Weld line
  • Sink mark

What is the name given to the linear defect that can appear in a molded material due to uneven cooling and solidification?

  • Sink mark
  • Air bubble
  • Foil crack
  • Weld line (correct)

Which defect typically results from uneven material distribution that leads to a depression on the surface?

  • Sink mark (correct)
  • Foil crack
  • Weld line
  • Air bubble

Which defect is characterized by a rupture in the material surface that resembles a crack?

<p>Foil crack (D)</p> Signup and view all the answers

In manufacturing, which of the following defects involves a visual or physical deformation caused by the material cooling and contracting unevenly?

<p>Sink mark (A)</p> Signup and view all the answers

Which of the following roles is associated with overseeing quality assurance related to incidental changes?

<p>QA Engineer (D)</p> Signup and view all the answers

What is the primary action suggested when an incidental or intentional change occurs?

<p>Confirm and contact based on the change list (B)</p> Signup and view all the answers

Which of the following is NOT listed as a type of change?

<p>Accidental change (D)</p> Signup and view all the answers

What is a suggested method for assessing changes in the process?

<p>List of limit samples for comparison (D)</p> Signup and view all the answers

Which individual is primarily associated with visual inspection in the context of changes?

<p>Faiskandar (B)</p> Signup and view all the answers

What type of process change is indicated for visual inspection of product dimensions?

<p>Directly associated with both resin and foil lot changes (A)</p> Signup and view all the answers

Which of the following statements about production sampling inspection is correct?

<p>It is applicable for both resin and foil lot changes (D)</p> Signup and view all the answers

Which type of material change requires visual inspections?

<p>Both resin and foil lot changes (C)</p> Signup and view all the answers

What type of adjustment is referred to when it states 'Adjustment(Outside the process window range)'?

<p>Changes made that exceed the established process window limits (A)</p> Signup and view all the answers

What conclusion can be drawn about process changes with respect to visual inspections?

<p>Visual inspections become critical when there are process changes. (D)</p> Signup and view all the answers

Which method is used for verifying product dimensions according to the content?

<p>Visual inspection (D)</p> Signup and view all the answers

What is true about the relationship between mold changes and inspections?

<p>Mold changes do not impact inspection requirements. (D)</p> Signup and view all the answers

In the context provided, what is indicated by 'Production sampling inspection/Measurement of control points and boss pin height'?

<p>Inspection measuring specific functional parameters (C)</p> Signup and view all the answers

What can be concluded if 'No' is frequently indicated in the inspections and adjustments?

<p>There are significant operational or quality control challenges present (C)</p> Signup and view all the answers

Which of the following reflects an improvement action based on the provided content?

<p>Changing process window parameters after thorough analysis (B)</p> Signup and view all the answers

Flashcards

Incidental change

Changes that happen unexpectedly or unintentionally during the manufacturing process. These changes might not have been planned for and can affect product quality.

Intentional change

Changes made intentionally to the manufacturing process, often to improve quality, efficiency, or meet new requirements.

List of limit samples

A list of specific samples from the production line that are used to compare with the overall quality of the product.

Visual inspection

Visual inspection is a method used to check for defects in products by using human eyesight.

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Measurement

Measurement is a method of checking product quality by taking precise numerical readings.

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Air bubble

A mark left on a product when air gets trapped during the manufacturing process. This can be a sign of improper molding or other issues.

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Sink mark

A mark left on a product when the mold doesn't completely close during the manufacturing process. This can be a sign of improper clamping or other issues.

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Foil crack

A crack in the foil used for packaging a product. This can be a sign of damage during shipping or handling.

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Weld line

A visible line on a product that shows where two pieces of material were joined during the manufacturing process. This can be a sign of poor welding or other issues.

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Process change - No visual or dimensional impact

Changes made to the manufacturing process that do not affect the visual appearance or the dimensions of the product.

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Process or material change - Requires visual / dimension inspection

Changes that require visual inspection to verify quality or to confirm product dimensions. These changes can be material related, like a new resin lot, or process related.

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Process or material change - Requires production sampling inspection

Changes that require a detailed inspection to confirm product quality or to ensure that critical control points are within acceptable limits. These changes generally require more than just visual inspection.

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What type of change is a "Resin lot change"?

A change in the type of resin used during manufacturing. This change may not be visible but can affect product quality.

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What type of change is a "Foil lot change"?

A change in the type of foil used during manufacturing. This change may not be visible but can affect product quality.

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Limit Samples

A set of specific samples from the production line that are used to compare with the overall quality of the product, ensuring consistency and meeting quality standards. This process can involve visual inspection, measurements, or other tests to analyze the quality of a representative sample.

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Measurement & Inspection

The process of using precise numerical readings to check the quality of a product, ensuring it conforms to a specific set of quality standards. This could involve checking dimensions, weight, or other physical properties.

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Study Notes

Incidental/Intentional Change List

  • This list details changes made to products, processes, materials, and personnel.
  • It categorizes changes as either incidental or intentional to track impact.
  • Focuses on tasks like checking quantities, overall measurement, visual inspection, and the quality of parts, such as the presence of white marks, lines, uneven coloration, and more.
  • Involves inspection of production sampling, confirming limits for comparison, visual inspection of product dimensions, specific measurements (like boss pin height), and overall measurements.
  • Some actions are prohibited (like parts repair) while others are required (like replacement of parts).
  • The list also tracks changes to molds, resins, foils, maintenance, and personnel assignments, considering training, transfers, equipment maintenance, and updates.
  • Includes a statement that construction is not permitted without permission.
  • Provides contact information for Kameoka Factory.

Process Changes

  • Categorizes process modifications as 'process change' or 'design change'.
  • Includes adjustments to process ranges within and outside of the specified parameters.
  • Notes changes based on Mold setup, repair, and polishing.
  • Also emphasizes whether there are adjustments made to the process window.

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