Module 3 Class Discussion Prep Assignment
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BIOT5219 20117 The Biotechnology Enterprise SEC 13 Fall 2023 Module 10 Class Discussion Prep Assignment 1) At what point do you need Quality?
Ans 1. Quality is crucial from the very beginning of business operations and remains essential throughout the entire life of your company. Here are key points at which quality becomes critical:
1.
Product Development Stage:
Design Phase:
Ensure that the product is designed with quality in mind. This involves considering materials, manufacturing processes, and potential points of failure (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
Prototype Testing:
Test prototypes rigorously to identify and address any quality issues before mass production begins (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
2.
Production Stage:
Quality Control:
Implement effective quality control measures during the manufacturing process to identify and rectify any defects or deviations from standards (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
Supplier Quality:
Ensure that the materials and components supplied by your vendors meet the required quality standards (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
3.
Market Entry:
Compliance:
If your industry is regulated, ensure that your products comply with relevant standards and regulations (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
Accreditation:
Consider gaining accreditation with recognized quality standards to enhance your reputation and market competitiveness (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
4.
Customer Interaction:
Meeting Expectations:
From the first interaction with your customers, it's important to set and meet their expectations for quality (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
Customer Feedback:
Actively seek and respond to customer feedback to identify areas for improvement (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
5.
Brand Building:
Reputation Management:
Your brand's reputation is closely tied to the quality of
your products and services. Consistently delivering high quality helps build a
positive reputation (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
Social Media Presence:
In the age of social media, customer opinions can quickly
shape your brand's image. Positive feedback can go viral, but negative reviews can spread even faster (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
6.
Cost Management:
Prevention of Defects:
Implement measures to prevent defects in the production
process. It's often more cost-effective to prevent quality issues than to rectify them after the fact (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
Efficient Processes:
Quality management can contribute to overall efficiency, reducing costs associated with rework, returns, and legal issues (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
7.
Long-Term Sustainability:
Customer Loyalty:
Quality is a key factor in building and maintaining customer loyalty. Satisfied customers are more likely to become repeat customers (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
Competitive Advantage:
In a crowded market, quality can be a significant differentiator, giving your business a competitive edge (
How to Upload Crisp Facebook Profile Pictures for Companies
, n.d.).
In summary, quality is not a one-time consideration but an ongoing commitment that permeates every aspect of your business. It's integral to the success, sustainability, and growth of your company.
2) What are the different roles for Supply Chain, Quality and Manufacturing?
Ans 2. Supply chain roles
encompass a wide range of responsibilities and functions, and professionals in this field can be categorized into four primary pillars: Planning, Production, Sourcing, and Transportation (
Which Supply Chain Job Is Right for You? Navigating the 4 Pillars
, n.d.).
1.
Planning: Load Planner, Demand Planner, Materials Manager, Materials Analyst, Supply/Demand Manager, Production Planning Manager, Vice President of Inventory/Supply Management (
Which Supply Chain Job Is Right for You? Navigating the
4 Pillars
, n.d.).
2.
Production:
Production Manager, Maintenance Operative, Principal Engineer, Packaging Engineer, Safety and Environmental Manager, Quality Manager, Vice President of Manufacturing Operations (
Which Supply Chain Job Is Right for You? Navigating the 4 Pillars
, n.d.).
3.
Sourcing:
Buyer, Purchasing Agent, Purchasing Manager, Inventory Clerk, Supplier Quality Engineer, Global Sourcing Manager, Technical Buyer, Strategic Procurement Manager, Director of Supplier Development
4.
Transportation:
Warehouse Administrator, Transportation Manager, Logistics Analyst
Logistics Manager, Route Optimization Manager, Director of Global Warehousing, Vice President of Distribution or Logistics (
Which Supply Chain Job Is Right for You? Navigating the 4 Pillars
, n.d.)
The roles in the quality
field vary in responsibilities and hierarchical levels.
1.
Quality Technician:
Primary Duties: Perform quality testing, gather data, report on inspection results,
write procedures, perform product qualifications, and calibration (
10 Job Titles for Quality Assurance (with Salaries and Job Descriptions)
, n.d.).
2.
Quality Auditor:
Primary Duties: Conduct audits on products, suppliers, systems, or processes, create reports, and follow up on audits with corrective actions (
10 Job Titles for Quality Assurance (with Salaries and Job Descriptions)
, n.d.).
3.
Quality Coordinator:
Primary Duties: Track and provide information related to quality assurance, ensure compliance with standards like ISO 9001, improve processes, generate reports, document QA systems, and may train other team members (
10 Job Titles for Quality Assurance (with Salaries and Job Descriptions)
, n.d.).
4.
Quality Assurance Tester:
Primary Duties: Work with the development team, design test plans, procedures,
and scenarios, perform tests, analyze test results, and create reports (
10 Job Titles for Quality Assurance (with Salaries and Job Descriptions)
, n.d.).
5.
Quality Control Supervisor:
Primary Duties: Oversee product testing, recommend technology or manufacturing improvements, assess production process issues, and supervise employee hiring, training, workflow, and development (
10 Job Titles for Quality Assurance (with Salaries and Job Descriptions)
, n.d.).
6.
Quality Analyst:
Primary Duties: Initiate and coordinate data collection, report to the quality manager, create reports, and use statistical methods (
10 Job Titles for Quality Assurance (with Salaries and Job Descriptions)
, n.d.).
7.
Quality Engineer:
Primary Duties: Inspect and improve products, monitor and develop inspection processes, decide on inspection and testing equipment, contribute to quality
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assurance policies, and write procedures (
10 Job Titles for Quality Assurance (with Salaries and Job Descriptions)
, n.d.).
8.
Quality Assurance Manager:
Primary Duties: Oversee quality assurance processes, encourage continuous improvement, solve quality problems, resolve suppliers' performance issues, recommend corrective actions, manage direct reports, and achieve QA management certifications (
10 Job Titles for Quality Assurance (with Salaries and
Job Descriptions)
, n.d.).
9.
Director of Quality:
Primary Duties: Oversee all quality assurance processes, set policies, create strategic plans, develop QA programs, train and coach employees, and serve as administrators of QA management systems (
10 Job Titles for Quality Assurance (with Salaries and Job Descriptions)
, n.d.).
10.
Vice President of Quality:
Primary Duties: Develop a work environment that encourages continual improvement, supervise the quality department, establish the direction for quality improvement, monitor the program, make necessary modifications, and report to the president (
10 Job Titles for Quality Assurance (with Salaries and Job
Descriptions)
, n.d.).
Manufacturing encompasses a broad range of roles
, covering various aspects of the production
process, quality control, engineering, and management.
1.
Manufacturing Specialist and General Manufacturing Associate Positions:
Manufacturing encompasses a diverse array of roles, covering various aspects of the production process, quality control, engineering, and management. In manufacturing specialist and general manufacturing associate positions, individuals may find opportunities in roles such as boilermakers, brazers, CNC machinists, and more. These roles involve hands-on tasks, such as fabrication, assembly, and quality testing. Entry-level positions may include floor assemblers, inspectors, and materials handlers, while those with specialized skills may become machinists, electronic assemblers, or production foremen (
Different Types of Manufacturing Jobs and Their Titles | Joblist
, n.d.).
2.
Manufacturing Operator Positions:
Operators play a crucial role in executing specific tasks in the manufacturing process. Whether as boiler operators, CNC operators, or specialized machine operators, these individuals focus on the operational aspects of machinery and processes. From chemical plant operators to printing machine operators, they contribute to the efficient and precise execution of manufacturing
tasks. The responsibilities range from controlling equipment to managing waste treatment processes (
Different Types of Manufacturing Jobs and Their Titles | Joblist
, n.d.).
3.
Office Manufacturing Positions:
The administrative side of manufacturing includes various roles that support the day-to-day operations. Positions such as buyers, financial assistants, and HR administrative officers ensure that the business aspects of manufacturing run smoothly. Marketing assistants, procurement administrators, and product development assistants contribute to the strategic aspects of manufacturing, demonstrating the diverse skill set required to manage different facets of the industry (
Different Types of Manufacturing Jobs and Their Titles | Joblist
, n.d.).
4.
Manufacturing Technician and Engineer Positions:
Technicians and engineers bring technical expertise to the manufacturing environment. From electromechanical technicians to industrial engineering technicians, these roles focus on maintaining and improving manufacturing processes. On the engineering side, professionals such as chemical engineers, design engineers, and quality engineers play pivotal roles in product
development, process improvement, and quality assurance (
Different Types of Manufacturing Jobs and Their Titles | Joblist
, n.d.).
5.
Leadership Jobs in Manufacturing:
Leadership positions are essential to guide and manage teams within the manufacturing sector. Supervisory roles, including assembly supervisors, maintenance supervisors, and manufacturing team leaders, oversee specific divisions. Management positions such as plant managers, production managers, and quality assurance managers take on broader responsibilities, ensuring the overall success and efficiency of manufacturing operations. Chief executives and directors, including chief of manufacturing and operations director, provide strategic direction and oversee the entire manufacturing process. Leadership positions showcase the importance of management and supervision in a technically advanced manufacturing landscape (
Different Types of Manufacturing Jobs and Their Titles | Joblist
, n.d.).
3) What does cGMP mean and why is it important? Ans 3. cGMP stands for "Current Good Manufacturing Practice," and it refers to a set of regulations enforced by regulatory agencies, such as the U.S. Food and Drug Administration (FDA), to ensure the quality, safety, and efficacy of pharmaceutical, biologic, and medical device
products. The term "current" emphasizes the need for manufacturers to use the most up-to-
date technologies and systems to meet the specified requirements (Research, 2023).
Here's why cGMP is important:
1.
Quality Assurance:
cGMP regulations are designed to ensure that pharmaceutical products are consistently produced and controlled to meet quality standards. This includes aspects such as the identity, strength, quality, and purity of drug products (Research, 2023).
2.
Patient Safety:
Adherence to cGMP is crucial for patient safety. The regulations help prevent issues such as contamination, mix-ups, deviations, failures, and errors during the
manufacturing process, which could otherwise pose risks to patients (Research, 2023).
3.
Flexible Standards:
cGMP regulations provide a flexible framework, allowing manufacturers to use scientifically sound approaches and innovative technologies. This flexibility encourages continuous improvement and adaptation to new and more effective manufacturing methods (Research, 2023).
4.
Preventing Defects:
The cGMP requirements include comprehensive controls throughout the manufacturing process, from design to testing. This helps prevent defects and ensures that drugs are manufactured under conditions that comply with the regulations (Research, 2023).
5.
Inspections and Compliance:
Regulatory agencies conduct inspections of pharmaceutical manufacturing facilities to determine compliance with cGMP regulations. This helps ensure that companies are following the necessary standards and
processes to produce safe and effective drugs (Research, 2023).
6.
Consumer Confidence:
Adherence to cGMP standards builds consumer confidence in the pharmaceutical industry. It assures consumers that the drugs they use are manufactured under rigorous quality controls and are safe for consumption (Research, 2023).
7.
International Standards:
cGMP is not limited to a specific country or region. Many countries around the world have adopted similar standards, facilitated international trade and ensured a global commitment to producing high-quality pharmaceutical products (Research, 2023).
8.
Continuous Improvement:
The emphasis on "current" in cGMP encourages companies to stay abreast of technological advancements and continually improve their manufacturing processes. This helps in maintaining the highest standards of quality (Research, 2023).
4) Based on the 5 in 10 and readings in this module, which group has ultimate approval authority for the Company's release of a product: Supply Chain, Quality or Manufacturing?
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(NOTE: FDA has technical authority to release vaccines; this question is about what we learned in this module, so in this case we are not talking about the FDA)
Ans 4. Quality has ultimate approval authority for the Company's release of a product (
CFR - Code of Federal Regulations Title 21
, n.d.).
References
10 Job Titles for Quality Assurance (With Salaries and Job Descriptions)
. (n.d.). Indeed Career Guide. https://www.indeed.com/career-advice/finding-a-job/job-title-quality-assurance
CFR - Code of Federal Regulations Title 21
. (n.d.). Www.accessdata.fda.gov. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?
CFRPart=211&showFR=1&subpartNode=21:4.0.1.1.11.2
Different Types of Manufacturing Jobs and Their Titles | Joblist
. (n.d.). Www.joblist.com. https://www.joblist.com/guides/different-types-of-manufacturing-jobs-and-their-titles
How to Upload Crisp Facebook Profile Pictures for Companies
. (n.d.). Small Business - Chron.com. https://smallbusiness.chron.com/upload-crisp-facebook-profile-pictures-
companies-51607.html
Research, C. for D. E. and. (2023). Facts About the Current Good Manufacturing Practices (CGMP). FDA
. https://www.fda.gov/drugs/pharmaceutical-quality-resources/facts-
about-current-good-manufacturing-practices-cgmp#:~:text=What%20is%20CGMP%3F
Which Supply Chain Job Is Right for You? Navigating the 4 Pillars
. (n.d.). EdX. Retrieved November 15, 2023, from https://www.edx.org/resources/supply-chain-
jobs#:~:text=Supply%20chain%20roles%20fall%20into