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Sep 22, 2010

Quality Control Vs Quality Assurance

It's not uncommon to hear the similar phrases quality control and quality assurance1 used interchangeably. This tendency, though a seemingly benign blunder, is actually a revealing reflection of an unhealthy quality management system.

What is quality control?

First of all, quality control is the "check" or the "end-of-the-immediate-task-at-hand" record or analysis that determines the acceptability or unacceptability of a product, a product plan, a product part, etc. Tasks related to quality control may include documented reviews, calibration, or additional types of measurable testing (sampling, etc.). Tasks related to quality control will reoccur more often than activities associated with quality assurance.

The Final Determination

Essentially, quality control is determined by the comparison of a product against the original specifications that were created before the product existed.

Who is involved with quality control?

Tasks related to quality control will usually require the involvement of those directly associated with the research, design or production of a product. An employee in charge of quality control related tasks is likely to report to his "local" department head and no further.

Quality Control Software: What functions should it perform?

Quality control software should be able to automate electronic "checks" and "tests" (best if done via a web-based system).

These checks may include the following quality control tasks:

• Customer complaints documentation.

• The record keeping of electronic forms or documents associated with step-by-step quality control processes.

• Forms routing.

• Automatic distribution and grading of training exams.

• Collaborative tasks.

What is quality assurance?

Quality assurance is more or less the determination of the processes that will determine the template and pattern of quality control tasks. Quality assurance assignments do not have to be measurable, although quality assurance evaluators will often use past experience or regulation as a guide for process determination.

The Final Determination

Essentially, quality assurance is determined by top-level policies, procedures, work instructions and governmental regulations.

Who is involved with quality assurance?

As opposed to quality control checks, quality assurance reports are more likely to be performed by managers, by corporate level administrators or 3rd party auditors.

Quality Assurance Software: What functions should it perform?

A quality assurance software solution should provide tracking and analytics (i.e. plus reporting features). A complete CAPA digital management solution is also a plus.

The most important function a quality assurance software solution however is flexibility and capability to be customized. After all, every quality assurance process determination will vary from company to company and a software solution should ideally be molded to the various needs of those companies.

The Importance of Distinguishing Quality Control from Quality Assurance Activities

It is important to treat the quality control tasks as separate from the quality assurance activities for the following reasons:

1) A product with continuous quality control checks may be entirely successful but the processes that govern those checks may still prove faulty (take too much time, too much revenue, etc.)

2) One person should not be performing both quality control and quality assurance assignments. Since quality assurance essentially controls the ebb and flow of quality control, having one person over both types of tasks is inherently a conflict of interest.

3) The two types of tasks are different. Why think about quality control and quality assurance as the same sort of process when quality control tasks are measured by specific details (i.e. numbers, specifications, etc.) and quality assurance activities are measured more by written policies, higher level work instructions or even by the opinions of management?

4) Some companies devote too much energy to quality control and some to quality assurance. Both processes must receive evaluation and management.


For life science and high-tech professionals an understanding of why quality control and quality assurance are important and how quality control and quality assurance tasks can best be accomplished are foundational building blocks for a strong regulated company.

Quality Control and Industrial Statistics. Fifth Edition