Quiz 3

Instructions:

This quiz covers the following material :

 ISO 9000
 Continuous Improvement Tools
 Quality Management System
 Understanding Teams
 QMS Documents
 Design . . .

This quiz is open-book. You may used your notes, texts, other reference materials, and even the internet to
answer the questions. However, you may not get assistance from another person. You are expected to
complete this quiz on your own.

Have fun, and good luck!

Question 1: 1 pt

To what does the ISO 9000 standards family apply?

Calibration
Efficiency & productivity
Quality system design & implementation
None of the above

Question 2: 1 pt

With regard to numbering of ISO standards, to what do the digits after the colon refer (e.g. ISO 9000:2000 )?

A page number
A release year
A section number
A sub-part

Question 3: 1 pt

If someone says that an organization is ISO 9000 certified, it means that the organization:

(select the best answer)

Has been audited by a 3rd party and found to be compliant with all relevant regulations
Has been inspected by the FDA did not incur any findings
Has fully met all the quality management system requirements mandated by ISO
None of the above
Question 4: 4 pts

The ISO 9000 standards family is based on 8 important principles.

Which of the following are some of these principles? (select all that apply)

Continuous involvement
Customer focus
Leadership
Management approach to leadership
Positive supplier relationship
System-based approach to decision making
Total process approach
Workforce improvement

Question 5: 10 pts

For each of the topics listed below, match it to the appropriate section of the ISO 9001 standard.

Control of nonconforming product Measurement, analysis and improvement

Customer-related processes Product realization
Design and development Product realization
Documentation requirements Quality management system
General requirements Quality management system
Infrastructure Resource management
Planning Management responsibility
Purchasing Product realization
Quality policy Management responsibility
Work environment Resource management

Question 6: 2 pts

What is the difference between ISO 9001 and ISO 13485?

ISO 9001 describes quality management systems requirements for any industry
ISO 13485 describes quality management system requirements for medical device companies

Question 7: 6 pts

For each of the situations described, select the best continuous improvement tool for the need.

Because you have excelled in your position at the Biotech R Us company, your supervisor decided to
increase your responsibilities by assigning you as the project manager for a new project. You are excited
 and feel you are well prepared to do a fantastic job given what you learned in the BTEC 490R Special
Topics course you took.

The project is novel requires some thinking about what expertise (e.g. techniques) and equipment at the
Biotech R Us company would be suitable. What tool would you use to identify the suitable expertise and
equipment? Brainstorming

With suitable expertise and equipment identified, what tool would you use to map out the workflow for
you and your team? Flowchart

The project is for a customer on a tight time line. What tool would you use to plan the work for you and
your team to facilitate efficient execution of the project? Gantt chart

One of the steps in the project requires screening for yeast cell lines that express a recombinant protein.
What tool would you use to record which cell lines screened show expression of this protein? Check
sheet

For the next step, it is desireable to have a cell line that expresses a high level of the recombinant protein.
However, the recombinant protein becomes toxic to the yeast cell host when the levels are too high. Two
of your team members have begun to measure milligram of expressed protein per gram of yeast cells in
those cell lines showing expression. What tool should you use to display the number of cell lines found to
express a particular range of milligram of protein per gram of yeast cells? Histogram

You and your team are on the home stretch of the project. The final step is purification of the recombinant
protein. One of the purification steps the team has chosen is FPLC (fast performance liquid
chromatography). You learned, in your other biotech courses, that FPLC purification is a complex
process and many variables have to be optimized for the process to be successful. After trying 3 times to
purify the recombinant protein, your team is finding the yield is much lower than typical and the protein
eluate is not as pure as it should be. What tool would you use to identify potential causes for this
outcome? Fishbone diagram

Brainstorming
Check sheet
Fishbone diagram
Flowchart
Gantt chart
Histogram
Matrix diagram
Pareto chart
Run chart
Scatter diagram
SPC chart

Question 8 a through g: 12 pts

Which statement(s) describe xxxxx ? Select all that are appropriate.

Corrective action e
Quality assurance b, i
Quality control h
 Quality improvement g
Quality management system a, c, f, j, k
Quality planning d
Preventive action l

(a) A component that is mandated by the FDA

(b) A “do it right the first time” philosophy
(c) Addresses training of personnel
(d) Designing a process capable of meeting quality standards
(e) Handling problems that have occurred
(f) Indicates preliminary definition and control of production and processes
(g) Involves decisions based on data and statistical analysis
(h) Involves measuring, comparing to a standard, and acting if not acceptable
(i) Involves the Plan-Do-Check-Act approach
(j) Indicated in 21 CFR 210/211 as well as 21 CFR 820
(k) Its exact structure is up to each organization to design
(l) Mitigating potential problems

Question 9: 3 pts

Explain how the Plan-Do-Check-Act cycle and continuous improvement are similar.

PDCA cycle is continuous/never-ending and focused on designing and implementing a plan, then
determining whether the results meet expectations; if not, then make the appropriate changes to
improve/correct the plan

Continuous improvement is the philosophy of constantly striving to do better, which requires analysis of
the current situation, and data-driven decisions for change

Question 10: 5 pts

Which of the following statements describes a team? Select all that apply.

A department or work unit within a company

A group working toward a common objective
All members are equally accountable for accomplishing a goal
Its purpose supports the organization’s plans and objectives
Members with skills that complement each other
Shall not disband until all goals are met
The executive management for an organization
When assembled correctly, can accomplish more than any one member can

Question 11: 5 pts

For each of the team roles listed below, identify who is primarily responsible for it.

Communicates with management f

Advocates for the team b
 May provide training for the team c
Accepts responsibilities for assigned tasks a
Manages conflict a

(a) All team members

(b) Champion
(c) Facilitator
(d) Scribe
(e) Sponsor
(f) Team leader
(g) Time keeper

Question 12: 5 pts

Sometimes teams take some time to gel and begin making progress. Explain why this happens.

Team development stages: forming, storming, norming, and performing.

Until the team reaches the performing stage, it may not be able to begin effectively working toward the
desired goals and objectives.

Question 13: 1 pts

How would you describe a company’s quality systems manual?

The company’s quality bible

Question 14: 3 pts

What is the difference between a SOP and a work instruction document ?

SOP is higher level general procedure

WID is lower level and provides step-by-step instruction

Question 15: 3 pts

SOPs and work instruction documents have similar elements. List 3 of these elements.

Organization identification (logo, name, address, etc.)

Document ID number
Revision number
Efffective date
Page X of Y
Document title
Document approval information
Document history/revision information
Question 16: 2 pts

Given what you know about writing work instruction documents and your recent experience doing so, explain
why writing such documents can be challenging.

Need for specifically vague vs. vaguely specific in order to maintain consistency when document is
followed so the desired outcome is reached while providing controlled flexibility so user is not locked in
to doing something a particular way that may not always be doable

Question 17: 3 pts

Some people use the terms “verification” and “validation” are used interchangeably.

You have been enlightened and know that this is incorrect. Explain the difference between these two terms.

“Verification means confirmation by examination and provision of objective evidence that specified
requirements have been fulfilled.” i.e. you built it right

“Validation means confirmation by examination and provision of objective evidence that the particular
requirements for a specific intended use can be consistently fulfilled.” i.e. you built the right thing

Question 18: 3 pts

For each of the following statements, identify the document it describes.

All the records that collectively describe the production history of a product b
All the records that collectively describe what the product is and how to make it c
All the records that collectively describes how a product was designed a

(a) Design history file

(b) Device history record
(c) Device master record