Title: Additional Quality Terms
Course: PW-Course-Import-Test > Section: Module 2: Quality Concepts and Principles

Module 2

In this section we will introduce and discuss additional quality terms and principles. Familiarizing yourself with these terms and principles will help you gain a better understanding of role as a quality inspector and quality concepts. We will discuss the following quality terms in this module:

1. Customers and Suppliers
2. Product Features
3. Fitness-for-use
4. Freedom from defects
5. Monitoring
6. Continuous Improvement
7. Cost of Quality
8. Quality Standards

Let’s discuss these quality principles in more detail.

Customer and Supplier Concept

This concept states that everyone may be a customer to someone and everyone has a customer. These customers can be internal to the company that you work in or external. Also one person’s customer may be another person's supplier. Internal customers can be anyone within an organization who at any time is dependent on anyone else within the organization. The external customer is the person who purchases the goods or services.

Let's imagine, for example, that you work in the receiving inspection department. After inspection you release components for use on the manufacturing floor. The operators on the manufacturing floor use these components to build the product. These operators on the manufacturing floor are your internal customers. You need to meet their expectations of timely delivery of quality components and prompt communication if these components are not going to be available for any reason.

A supplier who is a part of the same company as its customer is an internal supplier.

- They may provide products or services.
- They are the upstream processes and the support groups that provide their coworkers with the tools to do their jobs downstream.
- No money changes hands.
- Their customers don’t limit what they ask for.
- Poor performance and lack of responsiveness to an internal customer is disruptive to operations.

External suppliers provide goods and services to finished medical device producers.

- Ideally they partner with their customers to produce end products.
- Quality is responsible for checking quality of incoming materials.
- Suppliers are monitored for performance and corrective actions are requested for problems.

Let me give you another example here of an internal supplier with context to receiving inspection. The receiving inspection department is an internal supplier to the production floor. Then these parts are ‘supplied’ to the production floor. No money exchanges hands since the transfer of materials is within the sample company. This is different from an external supplier to which the company would send money when the components are received.

Product Features

Features of a product design are related aspects that help meet its intended purpose. These factors can include:

- Functionality

- Safety
- Comfort/Ergonomics
- State-of-the-art

Let’s review a couple of examples here that will give a better idea of this concept. Take, for example, a safety syringe as shown in the picture. One of the product safety features of this syringe is the lid (the pink part) that covers the needle when not in use. This would prevent accidental needle pricks.
Another product feature can be related to comfort. Take for example an intravenous catheter that is inserted in a patient for an extended period of time. Patient comfort is essential for the duration the catheter is inserted in patient. You cannot have the patient have excruciating pain and discomfort from the product during use. |

There are a lot other product features one can think off. Product features can help one product gain market share over another. Think about the smartphone. Companies manufacturing smartphones come up with new features every year. Some of these features are state-of-the-art and help improve user experience.

Fitness-for-use

This is a broad measure of quality with respect to an item's stated purpose. Effectiveness of a design, manufacturing method, and support process employed in delivering a good, system, or service that fits a customer's defined purpose, under anticipated or specified operational conditions. Also called fitness-for-use.

In short, it means that the products we build fulfill a customer’s needs, requirements, or desires.

Freedom from Defects

This is a narrower measure of quality to verify that the product conforms with specifications. These specifications are listed on a document or most likely on a drawing. This verification is done by performing inspection on the product in question. Acceptable Quality Limit (AQL) is used for these inspections. AQL is a statistical measurement of the maximum number of defects considered in a particular sample size.

Quality inspectors perform these inspection at receiving, in-process or at final inspection.

Process Monitoring

Is a method to collect in-process data. This data may come from various sources that may be manual or automatic. The process monitoring is usually plotted on a chart and the results then analyzed for trends. Control limits are set to check if the process is out of control.

Continuous Improvement

This is a long-term approach to work that systematically seeks to achieve small, incremental changes in processes in order to improve efficiency and quality. It can be applied to any kind of work, but it is perhaps best known for being used in lean manufacturing.

Continuous improvement of a process or product is the responsibility of every employee and not just a selected few.

Cost of Quality

During the manufacturing of a product, some of the product is wasted or loss on the way due to various reasons. The product may become damaged, lost or unfit for use for a different reason. Cost of Quality ("COQ")  is a measurement used for assessing the waste or losses from some defined process. These processes may include but are not limited to:

- Machine
- Product Line
- Plant
- Department
- Process

This figure shows a graphical representation of Cost of Quality. Conforming and nonconforming products both have costs associated with them. To ensure that products are conforming there are upfront costs of prevention and appraisal. For nonconforming products there are internal and external failure costs.

These costs are explained in some additional detail below:

Internal Costs are costs associated with internal losses when the process is being analyzed and nonconforming product is found. This product may need to be reworked or scrapped and these are the internal costs.

External Costs are associated costs when a third party, like a customer, discovers a defect in the product. The defect in the product was not detected before the product was shipped to the customer.

Preventive Costs are costs associated with prevention of future losses. This ensures that nonconforming product does not escape to the customer. Examples of this cost is training, clear procedures, etc.

Assessment Costs are costs associated with measurement and assessment of the process or product. Upfront inspection of the process or product can be expensive but can prevent other costs down the line.

Have you heard of the phrase "Freedom is not Free"? In the same way "Quality is not Free." You either spend time and money upfront to ensure that the process and product is robust enough or spend money later on scrapping product or addressing customer complaints.

Costs that are ‘visible’ are a fraction of the total costs. Like an iceberg, a lot of these costs are hidden under the surface and are not easily detected. These hidden costs can prove to be very costly to fix. |

Quality Standards

Medical device companies are subject to similar standards and regulations under which they need to operate. The processes and procedures that the company develops is in keeping with these standards. When a person moves from one medical company to another, these standards remain the same. Particular processes and procedures may change but are still developed in accordance with the standards.

The two common standards and regulations that most medical device companies follow are:

FDA 21 CFR 820 : Quality System Regulations

ISO 13485: Quality Management Systems