The quality agreement is a legal and formal document that defines the specific quality standards that need to be met for a project. This type of agreement also addresses the party that is responsible for ensuring that these standards are met. However, the specific quality requirements might vary according to the nature of the project. In U.S.A, quality agreements are not mandatory and yet they are strictly followed by the pharmaceutical companies that provide medical supply. This document is formulated according to the needs of the contractor or client and defines the purpose of this quality agreement very clearly.
The quality agreement is necessary as it clearly outlines what is expected from the project and the party responsible for the project at every step. The details that are included in this are the cost aspects, time management and the budget required for the project. The importance of this document is that it provides a regulatory environment within which the stated project must operate. This serves as a formal corporate agreement in the United States and hence, requires the mention of the types of vendors and services needed. This document can be formulated with the help of a hired contractor as it requires a certain amount of dexterity as well as professionalism. The following points are necessary for the proper drafting of the quality agreement:
- The document is required to be constructed only after the party responsible and the contractor has agreed to it. This ensures that both sides are aware of the responsibilities and expectations from this quality agreement.
- This agreement must enlist the necessary quality criteria that must be followed during the production, distribution and/or supply in the contract.
- The document must also clearly observe the different steps of the project and report on whether the standard is being met or not.
- This quality agreement document must mention the different departments of management that are involved like the operating personnel, human resources etc. This will give a clear picture as to who the responsible parties are.
- The language of the document must be simple with no added legal verbiage(1).
- This document must also include the individuals who are required to know the expectations from the job assigned so as to avoid any confusion for the later on. This quality agreement, thus, will act as a reference document for them.
Therefore, the quality agreement is a required process which will save a lot of time and money and ensure there are no legal issues between the two parties involved.