Do You Really Know What Lean Manufacturing Is?

1.

What is the objective of the Toyota Production System and Lean Manufacturing?

A.

To reduce cost
B.

To improve profit
C.

To eliminate everything that does not add value for the customer
D.

To optimize capital investment

Correct Answer
C. To eliminate everything that does not add value for the customer

Explanation
The objective of the Toyota Production System and Lean Manufacturing is to eliminate everything that does not add value for the customer. This means that the focus is on identifying and eliminating any activities, processes, or resources that do not directly contribute to meeting customer needs or enhancing customer satisfaction. By eliminating waste and non-value-added activities, the system aims to improve efficiency, quality, and overall customer value.

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2.

Can the Toyota Production System/Lean have an impact on the pharma supply chain?

A.

No, the pharma supply chain lies outside the range of the TPS/Lean philosophy
B.

No. The application of TPS/Lean is not permitted by the ICH harmonization documents
C.

Yes. TPS/Lean can focus, streamline and accelerate the pharma supply chain.
D.

It depends upon the regulations of the customer nation.

Correct Answer
C. Yes. TPS/Lean can focus, streamline and accelerate the pharma supply chain.

Explanation
The correct answer is "Yes. TPS/Lean can focus, streamline and accelerate the pharma supply chain." This is because the Toyota Production System (TPS) and Lean philosophy are known for their ability to eliminate waste, improve efficiency, and optimize processes. These principles can be applied to any industry, including the pharmaceutical supply chain, to improve productivity and reduce costs. By implementing TPS/Lean practices, the pharma supply chain can become more focused, streamlined, and accelerated, leading to better outcomes for patients and stakeholders.

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3.

Which was the first biopharmaceutical manufacturer to receive a Shingo Prize, which some have called the Nobel Prize for manufacturing?

A.

Abbvie Contract Manufacturing
B.

Baxter BioScience, Los Angeles
C.

Cangene Biopharma, Baltimore
D.

Toyobo Biologics, Osaka

Correct Answer
B. Baxter BioScience, Los Angeles

Explanation
Baxter BioScience, Los Angeles was the first biopharmaceutical manufacturer to receive a Shingo Prize, which is often referred to as the Nobel Prize for manufacturing.

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4.

Which TPS/Lean tools or techniques can be applied to CAPA?

A.

Five Whys root cause identification
B.

Genchi Gembutsu, also known as "go see touch"
C.

Poka yoke, aka mistake proofing
D.

All of the above

Correct Answer
D. All of the above

Explanation
All of the above tools and techniques can be applied to CAPA. The Five Whys root cause identification helps identify the underlying cause of a problem by repeatedly asking "why" until the root cause is determined. Genchi Gembutsu, or "go see touch," involves going to the actual location where the problem is occurring to gather firsthand information and gain a deeper understanding of the situation. Poka yoke, or mistake proofing, aims to prevent errors or mistakes from occurring in the first place by implementing mechanisms or processes that make it difficult for errors to happen. By applying all of these tools and techniques, organizations can effectively address and resolve CAPA issues.

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5.

Which comes first in the Toyota mission statement?

A.

Cost reduction
B.

Profit
C.

Quality
D.

Velocity

Correct Answer
C. Quality

Explanation
The Toyota mission statement prioritizes quality. This means that Toyota places a strong emphasis on producing high-quality products and delivering excellent customer satisfaction. Quality is considered a fundamental aspect of Toyota's business approach, highlighting their commitment to manufacturing reliable and durable vehicles. By prioritizing quality, Toyota aims to build trust and loyalty among their customers, ensuring that their products meet or exceed customer expectations.

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6.

What is the first rule of Kanban (replenishment)?

A.

Never pass defective items on to a downstream process or customer
B.

The customer only takes what is needed
C.

The upstream step only makes what is needed
D.

Smooth production

Correct Answer
A. Never pass defective items on to a downstream process or customer

Explanation
The first rule of Kanban (replenishment) is to never pass defective items on to a downstream process or customer. This means that any defective items should be identified and resolved before they are passed on to the next step in the process or delivered to the customer. By following this rule, the focus is on maintaining quality and preventing any issues from being passed along, ensuring that only high-quality products are delivered to the customer.

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7.

Who said, "Quality is the foundation on which both cost and delivery can be built."

A.

Michael Dell, Founder of Dell, Inc. and philanthropist
B.

Elon Musk, CEO of both SpaceX and Tesla Motors
C.

Masaaki Imai, author of Gemba Kaizen and founder of the Kaizen Institute
D.

Chris Viehbacher, CEO of Sanofi-Aventis

Correct Answer
C. Masaaki Imai, author of Gemba Kaizen and founder of the Kaizen Institute

Explanation
Masaaki Imai, author of Gemba Kaizen and founder of the Kaizen Institute, said, "Quality is the foundation on which both cost and delivery can be built." This implies that in order to achieve efficient and timely delivery of products or services at a reasonable cost, it is essential to prioritize and maintain high standards of quality. By focusing on quality, organizations can reduce costs associated with rework or customer dissatisfaction, while also ensuring that products or services meet or exceed customer expectations. This quote highlights the importance of quality as a fundamental aspect of business success.

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