| It's not uncommon to hear the similar phrases quality | | | | Essentially, quality assurance is determined by |
| control and quality assurance1 used interchangeably. | | | | top-level policies, procedures, work instructions and |
| This tendency, though a seemingly benign blunder, is | | | | governmental regulations. |
| actually a revealing reflection of an unhealthy quality | | | | Who is involved with quality assurance? |
| management system. | | | | As opposed to quality control checks, quality |
| What is quality control? | | | | assurance reports are more likely to be performed |
| First of all, quality control is the "check" or the | | | | by managers, by corporate level administrators or 3rd |
| "end-of-the-immediate-task-at-hand" record or | | | | party auditors. |
| analysis that determines the acceptability or | | | | Quality Assurance Software: What functions should it |
| unacceptability of a product, a product plan, a | | | | perform? |
| product part, etc. Tasks related to quality control | | | | A quality assurance software solution should provide |
| may include documented reviews, calibration, or | | | | tracking and analytics (i.e. plus reporting features). A |
| additional types of measurable testing (sampling, etc.). | | | | complete CAPA digital management solution is also a |
| Tasks related to quality control will reoccur more | | | | plus. |
| often than activities associated with quality | | | | The most important function a quality assurance |
| assurance. | | | | software solution however is flexibility and capability |
| The Final Determination | | | | to be customized. After all, every quality assurance |
| Essentially, quality control is determined by the | | | | process determination will vary from company to |
| comparison of a product against the original | | | | company and a software solution should ideally be |
| specifications that were created before the product | | | | molded to the various needs of those companies. |
| existed. | | | | The Importance of Distinguishing Quality Control from |
| Who is involved with quality control? | | | | Quality Assurance Activities |
| Tasks related to quality control will usually require the | | | | It is important to treat the quality control tasks as |
| involvement of those directly associated with the | | | | separate from the quality assurance activities for the |
| research, design or production of a product. An | | | | following reasons: |
| employee in charge of quality control related tasks is | | | | 1) A product with continuous quality control checks |
| likely to report to his "local" department head and no | | | | may be entirely successful but the processes that |
| further. | | | | govern those checks may still prove faulty (take too |
| Quality Control Software: What functions should it | | | | much time, too much revenue, etc.) |
| perform? | | | | 2) One person should not be performing both quality |
| Quality control software should be able to automate | | | | control and quality assurance assignments. Since |
| electronic "checks" and "tests" (best if done via a | | | | quality assurance essentially controls the ebb and |
| web-based system). | | | | flow of quality control, having one person over both |
| These checks may include the following quality | | | | types of tasks is inherently a conflict of interest. |
| control tasks: | | | | 3) The two types of tasks are different. Why think |
| • Customer complaints documentation. | | | | about quality control and quality assurance as the |
| • The record keeping of electronic forms or | | | | same sort of process when quality control tasks are |
| documents associated with step-by-step quality | | | | measured by specific details (i.e. numbers, |
| control processes. | | | | specifications, etc.) and quality assurance activities are |
| • Forms routing. | | | | measured more by written policies, higher level work |
| • Automatic distribution and grading of training | | | | instructions or even by the opinions of management? |
| exams. | | | | 4) Some companies devote too much energy to |
| • Collaborative tasks. | | | | quality control and some to quality assurance. Both |
| What is quality assurance? | | | | processes must receive evaluation and management. |
| Quality assurance is more or less the determination | | | | Conclusion |
| of the processes that will determine the template | | | | For life science and high-tech professionals an |
| and pattern of quality control tasks. Quality assurance | | | | understanding of why quality control and quality |
| assignments do not have to be measurable, although | | | | assurance are important and how quality control and |
| quality assurance evaluators will often use past | | | | quality assurance tasks can best be accomplished are |
| experience or regulation as a guide for process | | | | foundational building blocks for a strong regulated |
| determination. | | | | company. |
| The Final Determination | | | | |