QA TESt

You will find below a multiple choice questionnaire, you are asked to answer the questions only if you are sure of your answer this is why a good answer is worth 1, an abstention is worth 0 and a wrong answer is worth -2

Good test !

mandatory answer

Question 1

Please precise your name and last name

Question 2

Which tool(s) are most often used for root cause analysis?

5M + 5Why

Five Ws

Carol’s diagram

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Question 3

In what order would you use problem solving tools such as 5M – Five Ws - 5Why?

5M – 5 why – Five Ws

Five Ws – 5M – 5 why

5 why – Five Ws – 5M

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Question 4

What does the M of 5M (6M) mean?

Manner - Machines – Methods – Management – Materials – (Manpower

Manpower – Machines – Methods – Management – Materials –(Measurement)

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Question 5

What do the letters of the Five Ws mean?

Who – What – When – Where – Why

Which – Who – What – When – Where

Whose – What – When – Where – Which

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Question 6

In what form a 5M analysis is most often represented?

Gaussian curve

Pareto diagram

Ishikawa diagram

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Question 7

What kind of question should you prefer to ask during an audit?

Open questions

Closed questions

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Question 8

What is the difference between Corrective action and preventive action?

The corrective action aims to correct the identified cause, detected in order to avoid or reduce its recurrence (recurrence) while the preventive action will result from a risk analysis following the appearance of a problem or not in order to ' eliminate the potential cause in order to avoid or reduce its occurrence (occurrence)

The corrective action aims to eliminate, the identified cause, detected in order to avoid or reduce its recurrence (recurrence) while the preventive action will result from a risk analysis following the appearance of a problem or not in order eliminate the potential cause in order to avoid or reduce its occurrence (occurrence)

The corrective action aims to eliminate, the identified cause, detected in order to avoid or reduce its recurrence (occurrence) while the preventive action will result from a risk analysis following the appearance of a problem or not in order eliminate the potential cause in order to avoid or reduce its occurrence (recurrence)

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Question 9

What is a deviation?

A planned event appearing during the course of a process

A document provided for in production.

Any unforeseen event occurring during the course of a process.

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Question 10

What is a gemba walk?

Tour in the production area, where the added value of the product is created and learn on the spot how the process works.

The GEMBA walk is a tour of the production area by one or more managers.

The GEMBA walk is a tour of the factory, the production area, the workshop, by one or more workers.

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Question 11

What is ISO 9001?

A European law

An international law

A quality management system

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Question 12

What is the difference between QA and QC?

QA: ensures quality throughout the process including for activities while QC: Controls the quality of products at each stage of production by verifying compliance with specifications (specifications)

QA: Verifies all operations and ensures quality throughout the process including for activities while QC: Controls product quality at each stage of production by verifying compliance with specifications (specifications expenses)

QA: Verifies all operations and ensures quality throughout the process including for activities while QC: ensures product quality at each stage of production by verifying compliance with specifications (specifications)

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Question 13

What is the objective of Quality?

Quality is there to ensure that the product meets the needs expressed by management.

Quality is there to ensure that the product meets the needs expressed by the salesperson.

Quality is there to ensure that the product meets the needs expressed by the customer

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Question 14

What risks can GMP prevent?

Contagion - Forgotten - Error – Contamination

Confusion - Forgotten - Error - Contamination

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Question 15

If the objective of the management is to increase quality by 300% in 6 months, Can we say that this objective is SMART and why?

YES

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Question 17

With the aim of improving production conditions, the general manager of the company has decided to install a new packaging line that is faster but does not modify the process per se. All of this happened during your absence.
what documents related to this improvement do you expect to find on your desktop?

a change control document

specifications

a call for tenders

a validation document

a training document

a procedure

a work instruction

a risk analysis

a document attesting that production with the new equipment has started

Question 20

For a company, what will define the quality of a product?

the needs of its customers

the regulations

the life of the product

the solidity of the product

product profit margin

Question 21

What is quality improvement?

Quality improvement is based on the principle that customer needs are constantly changing and that in order to be able to meet these needs, the company must constantly "renew" itself and improve.

Quality improvement is based on the principle that in order to remain competitive and retain customers, the company must constantly improve.

Quality improvement starts from the principle that quality must constantly be improved to meet regulatory requirements.

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QA TESt

Please precise your name and last name

Which tool(s) are most often used for root cause analysis?

In what order would you use problem solving tools such as 5M – Five Ws - 5Why?

What does the M of 5M (6M) mean?

What do the letters of the Five Ws mean?

In what form a 5M analysis is most often represented?

What kind of question should you prefer to ask during an audit?

What is the difference between Corrective action and preventive action?

What is a deviation?

What is a gemba walk?

What is ISO 9001?

What is the difference between QA and QC?

What is the objective of Quality?

What risks can GMP prevent?

If the objective of the management is to increase quality by 300% in 6 months, Can we say that this objective is SMART and why?

Why ?

Among all these agencies, which are regulatory agencies?

What Standards can be applied for Medical Devices?

For a company, what will define the quality of a product?

What is quality improvement?