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The mission of a quality assurance department is to provide an effective and efficient quality assurance system and counsel for the operational units. The quality assurance department must be manned by an adequate number of dedicated and adequately qualified and trained personnel with well-developed interpersonal skills. The well-developed interpersonal skills will provide the quality assurance personnel with persuasive, diplomatic, tactful and resilient qualities generally required of them. The quality assurance department must operate independently from the operational units and it must regularly perform quality review activities (self-inspection audits/internal audits) to ensure compliance within operational units with Company quality standards, good working practices [GxPs: current Good Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), GCP, etc.], and local, national, regional and international legal, ethical and regulatory requirements.
Other activities include.,
•Defining and documenting a quality policy and quality objectives and ensuring that both the policy and objectives are understood and implemented by all employees at all levels;
•Ensuring that appropriate processes are implemented to fully satisfy customer needs and expectations and Company objectives;
•Defining and documenting the responsibility, authority and interrelation of key personnel managing the quality systems;
•Providing adequate resources for implementing and maintaining the quality systems;
•Conducting scheduled management reviews of the quality systems to assess their continued suitability, adequacy, effectiveness and efficiency; and •Deciding on actions for continual quality improvement.
Simply, the quality assurance function is a main arm of the top management and its primary mission is to bring top management' quality policies into reality, so the QA needs to report directly to whom assigned the task. Also, QA should be independent, neutral, unbiased, ...etc to protect its objectivity and credibility among the other depts. I even think it is better for the head of QA not to have big experience in the industry of his organization to avoid any technical involvement. QM standards are based on defined authorities and responsibilities, interference between those threatens the QMS sooner or later.
According to ISO9001, the management representative (M.R) should report to the top management.
It is not necessary that the director of Quality Assurance to be the M.R. it could be a different person.
any how, it is called Quality Management System.
the management is the link between the Quality and System
1- To assure top management commitment to quality.
2- Segrigation of duty and confilict of interest, require QA to be independent.
3- QA is always before the product is allowed to be produced, hence QA approval is extension to top management approval.
4. QA interest in assuring quality transparently regardless of the P&L.
Mainly to avoid any conflict of interest
Quality is what one offers to his customers and the aim of top management is to have more customers, with great satisfaction. Therefore, the Quality Team needs to be in close and direct contact with top management. So that they inform the top management from any non compliances the sooner it can be possible.
Beacuse you needs to get your planning approved form Management.
Beacuse you need Resources for Implementation of System
Beacuse Management Vision should be aligned with the Objectives systems is persuining
. . .
The quality assurance is an essential function at any organization; if you do not have a quality you will not have a good product, and that will defiantly reflect on the financial situation of the entire organization from top management up to labors.
Be because of the executive departments, and directly by the
To avoid conflict of interest if Quality report to anyother functions and it is the back bone of any organization
