Industrial Regulation and Quality

Midterm Exam

The midterm is being offered as a take home examination. You will be given two weeks to complete. Must be submitted by October 23, 2012 no exceptions!!! Students will be able to use class notes, reading material and the internet. However, no copying of other work will be allowed including the internet sites!!! All answers must be in your own words. The school honor code is in effect and students are not permitted to work together or share answers.

Material will cover Module 1 to 5 readings, class discussions, homework assignments including case studies.

Please place your name on the document submitted. Send by email back to me at .If there are any other questions, please contact me for clarification.

Questions and Grading Structure

25 True/False (1 Point each)25

20 Multiple Choice (1 point each)20

10 Fill in the blank (2 points each)20

5 Essay Questions (7 Points each)35

Total Value100

Industry Regulation and Quality

Class Midterm

Fall 2012

Name ______

True/False Questions (1-25)

  1. The EPA can set regulations for effluent output of chemical plants in the United States.

True ______False ______

  1. One difference between cosmetics and pharmaceuticals is that cosmetics do not need approval from the FDA prior to selling the product.

True ______False ______

  1. New technology can create new regulations that will prevent it from being approved for use in industry.

True ______False ______

  1. The National Institute of Standards and Technology (NIST) can set regulatory standards for the FDA

True ______False ______

  1. Customers can define products features and only internal quality assurance can define defects.

True ______False ______

  1. A quality system has a cultural component which can never be explicitly stated in company documentation.

True ______False ______

  1. Product quality attributes are important through all phases of the product lifecycle for the same reasons.

True ______False ______

  1. Quality Function Deployment connects the voice of the customer directly to the process requirements.

True ______False ______

  1. Concurrent engineering is used to leverage process considerations during product design and maintains a separation between the R&D department and the process engineering group.

True ______False ______

  1. To enable quality systems in the pharmaceutical industry, companies utilize quality risk management and knowledge management to identify major issues and share best practices.

True ______False ______

  1. It is not the responsibility of senior quality management to review quality systems of its suppliers.

True ______False ______

  1. The quality control group supports organizations with audits and the quality assurance provides real time testing of the product attributes.

True ______False ______

  1. The culture of an organization is said to have quality as a priority if it focuses on the needs of the customer, individuals are accountable and responsible, activities support regulatory needs, but above all will not compromise on meeting the company’s financial targets to meet market expectations.

True ______False ______

  1. Setting up a Quality Council between Nabisco and its suppliers of bakery ingredients such as flour, sugar and preservatives is an example of a governance model.

True ______False ______

  1. In Maslow’s theory of motivation of employees, lower levels of satisfaction must be satisfied before high levels can be used to motivate employees.

True ______False ______

  1. An example of good change management is to reward the new behavior and punish the old behavior in public.

True ______False ______

  1. To transfer tacit knowledge between experience operators in a plant to new trainees, OJT would be recommended to supplement formal classroom training.

True ______False ______

  1. For a quality system to support a strong change control process, an impact assessment of the proposed change would be reviewed only by senior quality management to ensure proper decision making.

True ______False ______

  1. Auditing a supplier for compliance with your company’s quality agreement, requires the lead auditor to be selected from the supplier who actually performs the work on a regular basis and reports back to the organization requesting it.

True ______False ______

  1. One of the most important aspects of quality auditing is to identify deficiencies and correct them during the audit.

True ______False ______

  1. As part of the best practices in quality risk management, all identified risks in a manufacturing process will require mitigation as well as a risk reduction.

True ______False ______

  1. As stated in the 21 CFR Part 211 GMPs, process specifications are used to release the product from manufacturing?

True ______False ______

  1. If possible, evaluating a quality attribute with a quantitative measurement is always preferable to a qualitative measurement?

True ______False ______

  1. A batch of cheese is rejected due to not passing microbiological test results.It was found later that the microbiologists in the lab accidently contaminated the samples. This would be considered a Type I error.

True ______False ______

  1. The concept of acceptance sampling means that by taking the minimal sized sample required and if results fall within the acceptance range, this will always guarantee that you will have acceptable product.

True ______False ______

Multiple Choice Questions (26-45)

  1. Which branch of the federal government agency creates regulations

A.FBI

B.EPA

C. Legislative

D.Judicial

  1. Which regulation covers the laboratory practices covering quality control methods and standards used on cold medicine?
  1. Title 29 Subpart G 1910.1450
  2. Title 21 CFR 211 Subpart I Section 165
  3. ASTM E1578 - 06
  4. USP 797
  1. Which company strategy is impacted by regulatory compliance?
  1. Manufacturing
  2. Quality
  3. Marketing
  4. All of the above
  1. Which is not an example of cost of poor quality?

A. Regulatory Affairs department

B.Inefficient manufacturing process

C.Product recalls

D.Lean Six Sigma training

  1. Which stage of the product lifecycle would require a re-formulation of a polymer used in a medical device packaging to better compete in the marketing place to support “Greening the environment?”

A. Introduction Phase

B. Growth Phase

C. Maturity

D. Decline

  1. Which phase of the Quality Function Deployment process convert Product Specifications into Process Specifications?
  1. Performance Requirements
  2. Process Design
  3. Product Design
  4. Process Control
  1. Which principle is the most common across all GxPs?

A.Ensure documentation is created and maintained.

B. Patient Safety during clinical trials

C. Manufacturing processes are controlled and any changes to the process are evaluated prior to implementation.

D.All quality systems are maintained during the experimental research

  1. What is the difference between a quality mission and the quality strategy?

A. Mission defines the long term goal and the strategy is how they get there

B.Mission is how they get there and the strategy is the organization’s purpose

C. Mission is the organization’s purpose and the strategy is how they get there

D.Mission and strategy are basically the same

  1. Which organization will interface with the manufacturing group on a daily basis to ensure all complains and defects found in the marketplace are evaluated along with manufacturing to determine their root cause?

A.Regulatory Affairs

B.Quality Control

C. Quality Assurance

D.Legal Group

  1. Which is an example of a self managing team to support quality initiatives on the factory floor?

A.Quality Circles

B.Six Sigma Team

C.Project team composed of a quality control microbiologist, manufacturing supervisors and an engineering project manager

D.Leadership team made up of the plant manager, quality assurance site manager and engineering manager

  1. Which type of group would provide the best quality governance across multiple plant sites?

A.Corporate group of quality staff personnel who have worked at the site level

B.Group of line operators from each plant handpicked by their respective plant manager

C.Quality Assurance leaders from each site and a central VP of Quality

D.Quality consultant facilitating quality control managers at each site

  1. If management believes that it is not possible to trust employees to maintain good change management procedures, they subscribe to which motivation theory.
  1. Theory X
  2. Theory Y
  3. Expectancy theory
  4. Hertzberg theory of dissatisfaction
  1. Which type of training will prepare an employee with specific requirements of running a cosmetic packaging line?

A.Industry sponsored course on packaging operations

B.Graduate course at Manhattan College of Engineering

C.In house classroom training course reviewing SOPs

D.OJT coupled with in house training course reviewing SOPs

  1. What proposed change would not require a change request form?
  1. New heat exchanger to be implemented in a validated pharmaceutical process vessel
  2. Change in the price of your chemical pesticide during the summer timeframe

C.Moving the manufacturing process from a North Carolina facility to a new facility in South America

D. Implement a new process analytical technology to measure viscosity of a hand cream during its blending stage

  1. Which good documentation practice would minimize using the wrong batch recipe in manufacturing?

A.Security control with paper based document

B.Computer based availability with version control

C.Traceability table showing how the current batch recipe is tied to past development work

D.Genealogy of where the document is referenced

  1. If a recent quality audit by your corporate auditing group from headquarters is planned for at the distribution center of your company and you are the QA site manager responsible there, what actions would you select to be best prepared for the audit?

A.Ensure the staff and management is aware, request an agenda for the audit and makes preparations for the audit team visit

B.Hire a cleaning company to one week prior to make sure the facility is clean and all items are stored correctly

C. Run a mock audit internally and fix what you find prior to the visit

D.Hire a consultant to review all documentation and facility for compliance with all regulatory requirements

  1. Which process risk is highest using Severity Scale 1 (low) -5 (high) and Probability Scale 1 (low) – 5 (high)?A. Cooling system on chemical reactor which could impact the area for 10 miles (Severity 4, Occurrence 2)

B.Unable to achieve the eutectic point on a freeze dryer process used on a costly biotechnology product (Severity 3, Occurrence 4)

C.Failure of the pH control system of effluent from the plant causing major contamination of a nearby river (Severity 5, Occurrence 1)

D.Microbiological contamination of a corn supply to Kellogg’s cereal plant (Severity 3, Occurrence 3)

  1. What is the sample size and reject rate required on a process which makes 175,000 dietary supplement tablets per lot and an AQL of 0.1%?

A.315, Ac 3 Re 4

B.315, Ac 0 Re 1

C.800, Ac 1, Re 2

D.800, Ac O, Re 1

  1. Measuring customer satisfaction using a Likert Scale such as (5 is excellent, 4 above average, 3 average, 2 below average, 1 poor) is an example of what type of measurement scale?
  1. Ratio
  2. Interval
  3. Ordinal
  4. Nominal
  1. What is required in a properly designed quality control lab to measure potency of a biological product?

A.established measurement and well defined standard which is repeatable and reproducible

B.established measurement and several years of good test results on the same product

C.Established measurement, well defined standard which is repeatable and reproducible as well as approved SOPs and up to date training of personnel

D.Established measurement, well defined standards which are well managed under a change control system

Fill in the Blank Question (46-55)

  1. The department of ______is responsible for consumer product safety in the United States.
  2. The regulatory counterparts for the FDA in the Europe and Japan countries are ______and ______respectively.
  3. Industry has reacted to over regulation by enlisting ______to support their causes in Washington D.C.
  4. Product quality can be defined many ways. In class we discussed comparing product attributes to specifications is an ______view while a company comparing the product attributes to a competitors a benchmarking study would be a ______view.
  5. The practice of Good ______Principles, would have improved the Heparin case study.
  6. According to ICH Q10, the three objectives of quality systems are to ______, ______and ______
  7. In this semester we discussed how important culture is to establishing quality in an organization. We adopted the definition of culture as a set of ______, ______and ______that focuses on quality.
  8. According to Kotter’s model of change, the first requirement to change an organization is to ______and the important last step is to ______.
  9. When making corrections to errors in pharmaceutical manufacturing batch records, each item corrected requires (four items) ______, ______, ______and ______.
  10. In order to have a good measurement system on a product quality attribute, you need to have a ______, ______and ______.
    Essay Questions (56-60) limit to 250 words per answer
  1. Your have been requested to prepare a brief for the republican presidential candidate Mitt Romney to justify reducingthe regulatory budget of the FDA. Using our discussions in class as well as the case studies, explain your approach while keeping in mind that you have been told that many products planned for approval by the FDA during his upcoming termare planned to come from overseas facilities. In addition, many news articles and FDA special committee briefings have been generated with concern on the pharmaceutical supply chain quality due to limits of FDA physical inspections. In summary, this might jeopardize the safety of the US population and the candidate wants to impress voters with his approach. Assume more inspections will require more funding and the candidate is campaigning in the direct opposition.
  2. Your havebeen hired as a quality consultant for a biotechnology company which has recently been cited by the FDA on numerous issues in one of its manufacturing facilities. You have been requested to develop a quality program to mitigate this situation. Describe an implementation plan for all the major elements and rationale behind it.
  3. How would a documentation system support the needs of a medical device during it product development phases?
  4. Explain how quality risk management methodology supports regulatory compliance within a pharmaceutical organization?
  5. An existing chemical plant currently uses a complex laboratory analysis to determine the chemical composition of the finished product. A new chemical engineer hired with an expertise in process analytical technology knows of a new instrument that can be installed in-situ to measure it and eliminate the laborious work in the laboratory. As the quality assurance specialist, you have been requested to work with the engineer to develop a business case to replace the existing laboratory analysis. Describe the benefits of using the new technology from a quality perspective.