Running head: HOMEWORK SET 2 1

Homework set 2

Dawn Moore

MGT 410

13 September 2019
HOMEWORK SET 2 2

1. Define the term system.

The system is a collection of interdependent parts that are working together to achieve some

common goal. Quality management is also a system of the organization, and it ensures that quality

of the materials, products, and services or the processes will satisfy customer needs. It is a

structured system that specifies the responsibilities, processes, and procedures needed to achieve

good quality in all aspects of products and services.

2. What are the main differences between ISO 9000 and the MBNQA?

ISO 9000 is a standard that defines the basic elements of a quality system. But ISO 9000 does

not specify how an organization should implement these quality elements. MBNQA stands for The

Malcolm Baldridge National Quality Award. These acts as guidelines for quality systems. MBNQA

contains the seven categories, and it defines the components of quality that are required to obtain

the award. ISO 9000 directs the organization to follow the quality standards and organization can

obtain the certification of this, whereas after obtaining the certification organization can apply for

MBNQA award. Based on seven categories, the organization may win the award.

3. What are the key components of Six Sigma?

Six sigma is the method of improving organizational performance by reducing defects and

waste. Six sigma enhances the capabilities of organization processes by decreasing the process

variation. It brings improvement in profits, higher employee morale, and efficient quality. Six

sigma uses the tools of quality, statistical analysis, and experimental design to evaluate the

processes. Six Sigma improves processes, communication, and teamwork within the organization

structure. It also uses the define, measure, analyze, improves, and control approach to improve

quality.
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4. Discuss the differences between a first-party, second-party, and third-party audit.

First party audit refers to the internal audit. The purpose of this audit is to measure the strengths

and weaknesses of the organization with its set standards and procedures.

Second-party audit refers to external audit. These audits are more formal and structured. For

example, organization conducts an audit of a supplier as an auditor or being audited by the

customer as auditee. A third-party audit is conducted by someone who is neither the supplier nor

the customer. This is conducted by the external party. Example of third party audit would be ISO

9000 audit who will assure or confirm the quality of processes and products and services of the

organization.

5. Discuss the importance of data accuracy and integrity in a quality information system.

Information systems collect data, store data, transmit and retrieve data for future purposes.

Quality information systems are important because they ensure that higher quality is achieved in

all of the organization processes. Information should be delivered at the right time, the right person

or the right format. The information system is crucial to ensure the quality of the products and

service given to the customers. Data accuracy ensures that data that is received and transmitted is

accurate, and there are no or minimum errors in the data. Automation in data processes can

facilitate the organization to get and transfer the right amount of information.

6. What are the purposes of quality documentation systems?

`Quality documentation system includes the documentation of all processes and procedures

adopted by the organization to develop products and services. The quality documentation system

is important because they help to ensure that all defects are identified and noted, and corrective

actions are taken to minimize the errors and defects. Quality documentation system facilitates the

audit process.
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7. What would be the foremost characteristics of an acceptable sampling plan for critical

defects?

Minor defects are the defects that do not affect too much to the operating unit or quality. Class

D defects are the defects are that are acceptable because they are minor and does not cause the

operating unit to fail.

8. A manufacturer approaches a customer and asks which of the 237 dimensions on the

blueprint are critical. The customer replies that they expect the product to be in

conformance to all of the dimensional specifications--therefore they are all critical. Is

there a better approach the manufacturer could have taken with the customer?

Discuss.

Customer response regarding specifications is right. He informs the manufacturer that all 237

dimensions are critical; if he says that anyone dimension is not critical the manufacturer might not

take it seriously and takes a shortcut in producing it. The result of that unseriousness would be the

product that does not meet its intended purpose.

9. What are some of the categories of information which might be important to include

on product packaging? When would it be appropriate and desirable to include this

information on the product itself?

Categories that are important to include in the product packaging are:

i. Content identification

ii. Tracking instructions etc.

Other information might be included in product packaging are manufacturer, type of container, lot

number, product or batch size, etc. It would be appropriate to include this information on product

when it has plastic molded parts or metal parts.

10. Why might lot traceability be more important in pharmaceutical manufacturing

than in writing instrument manufacturing?

In pharmaceutical manufacturing lot traceability is important because they are similar in

physical appearance. All look like the same in shape and size. Lot traceability is important because

it helps to identify unique date codes and lot number.