The Quality Assurance Plan (QAP) have a number of standard objectives:
1. QAP as an initiator: It is a plan, and without a plan objectives will be compromised. The QAP is imperative to include all departments within the organization, therefore ensuring things happen while covering the entire organization and sets baseline standard for performance.
2. QAP as an enforcer: It becomes a baseline or benchmark for all sections. To ensure they know their quality targets and their performance can be measured by comparison to the benchmark. An example of this can be found when there’s temptation to skip a test or stage when the project is behind schedule, it may speed up the process but damage everything else. QAP, if followed, ensures that all required steps are followed and prevents work hazards from occurring.
3. QAP as a statement of procedures: Detailed quality requirements are clearly stated in the QAP. That too for all stages. The QAP outlines the tests and checks required for all components with detailed outlines on procedures. It also gives insight on how the test will be performed therefore the tester has enough time to prepare the date and schedule.
4. QAP as a cost and schedule plan: The QAP outlines the time and money required for all stages in the process, therefore it acts as a time and cost plan. By knowing the cost required to reach the benchmark theres few chances that quality will be compromised.
5. QAP as a yardstick: The QAP acts as a yardstick. Once you compare the amount of planning taken against the benchmark you can weigh the degree of quality. This comparison reveals if an increase in quality planning is required
6. QAP as a generator of uniform quality: Variance in quality is caused by difference in experience, style, ability and attitude. If there’s a benchmark set then these variances should diminish as they have to follow the guidelines not their gut.
7. QAP as an encouragement to attend to standards: Employees rarely read entire thick manuals and therefore skip precious information. However if theyre told where they can find the quality checks before the start of the project, they can adhere to them.
An example of the benefit of QAP can be found in those sponsors for clinical trial and contact research establishment to monitor and manage their work in order to provide high quality products to fulfill customers needs. (Manghani 2016) The well-written QAP will include the SOPs along with different quality documents. This helps the company business achieve its objectives which can not be ignored indefinitely becoming a passport for success. (Lücke 2008) The QAP benefits the organization by:
· Satisfaction of customers, loyalty and recommending business to others
· Removal of waste (time) enable registration of drugs on time.
· Increase in revenue including increas market shares (in the long run) and more export reliability
· Motivating employees and providing them with quality experience which will help them in all aspects of life.
· A positive performance by the company can attract and build confidence of interested parties to attain financial and social gains.
CONSEQUENCES
A product can become obsolete if it does not undergo continuous improvement which is provided by QAP. Furthermore, the workforce will lose productivity if its not involved in the development and manufacturing of quality goods that satisfy customers. (Tramontana 2018) On top of which, an unsatisfied customer will look towards another similar product that adhere to their needs. The company will lose its market shares and taint its reputation. Moreover, not having a document control and management quality system will make a company’s growth stagnant. Without the QAP the workers can work as they see fit and they can’t be hold accountable as there’s nothing to benchmark their poor performance with. Once experience employees leave they take their valuable knowledge with them, leaving the newcomers uneducated to quality standards if there’s no QAP. All of this will result the company unable to do business with top organizations as they all require quality in work. Quality can also be said to be referred to as trust. If your quality is good, everyone trusts what you sell and do.
