Title: What are Specifications?
Course: PW-Course-Import-Test > Section: Module 3: Acceptance Criteria

Module 3

In this section you will learn about specifications. Specification of parts to be inspected are usually present in the engineering drawing. Quality inspectors refer to these drawings before initiating any inspection.

Specification

A specification can be defined as:

1. an act of describing or identifying something precisely or of stating a precise requirement
2. a detailed description of the design and materials used to make something
3. a Standard of workmanship, materials, etc., required to be met in a piece of work

The FDA defines specifications as any requirement with which a product, process, service or other activity must conform.

Some examples of specifications include:

- Descriptive title, number, identifier, etc. of the specification
- Terminology, definitions and abbreviations to clarify the meanings of the specification
- Test methods for measuring all specified characteristics
- Material requirements: physical, mechanical, electrical, chemical, etc.
- Acceptance testing, including Performance testing requirements, targets and tolerances.
- Certificate of conformance (C of C), or certificate of analysis (C of A)
- Safety considerations and requirements
- Environmental considerations and requirements
- Acceptance sampling, inspections, acceptance criteria
- Provisions for rejection, re-inspection

In short the specification of the part tells the quality inspector important details of the component, what to inspect for and the sampling plan. Any part that meets these specifications is acceptable. Any part that does not meet the specification is non conforming.

You use specifications in your day to day life too. Consider going grocery shopping. You want ‘ripe’ bananas to make banana bread at home. Here ‘ripe’ is a specification.  Another example is when you go to a home improvement store you ask the salesperson for a #7 x 1.625-in Countersinking-Head Stainless Steel Star-Drive Deck Screw. All these are specifications of the screw you want.

Types of Specifications

- Characteristics Specifications: These type of specifications describe the characteristics of a component or finished product. Such a characteristic is usually verified by the quality inspector by visual inspection. Let’s take for example the syringe shown in the picture. A characteristic specification for it would be for the quality inspector to verify the presence of the ‘Single Use Only’ statement on it. |
- Design/Technical Specifications: These type of specifications describe the design or engineering requirements of the product or component. To verify such a requirement, the quality inspector may have to measure a particular dimension and verify it against this specification. Take for example the medical tubing as seen in the picture. An design or technical specification for this tubing can be the dimension of the holes, like the dimension of each hole needs to be 0.10 +/- 0.02 inches in diameter. |
- Performance/Functional Specifications: These type of specifications dive into details of how the product is intended to be used by the end user or how the product is intended to function. For this type of specification, the quality inspector is expected to test the product in a way the end user would use it. For example, let's take a wrist oxygen meter shown in the picture. For such an instrument a quality inspector may be required to turn the instrument on to see if it lights up the display as intended. |