Quality Plan for a Product or Service Realization

The product and service provision planning process defines the following controls, as appropriate to the product. This plan is sometimes called a quality plan.

The quality objectives and regulations

  • Quality objectives should be measurable, consistent with the quality policy and relevant to product and service conformity.
  • They should contribute to the enhancement of customer satisfaction.
  • Quality Objectives should be communicated throughout the organization and updated to ensure relevance to changing business needs.
  • An effective quality management system should align the quality policy with objectives.
  • It will provide the framework upon which to translate these objectives into functional targets.

The necessary processes, documents and resources

The required checks and criteria for product acceptance

  • How do I monitor and measure product characteristics?
  • Establish and define the process for inspection and testing activities to verify that products and materials conform to specified requirements throughout the product realization process by identifying appropriate: References, e.g. specifications or legal and regulatory requirements; Methodology, e.g. random sampling,non-destructive testing or in-process monitoring; Documents, e.g. inspection and test plans; Acceptancecriteria, e.g. defined by ISO standards, legal or regulatory requirements; Responsibilities, e.g. authority for acceptance

The records needed

  • A document can be thought of as a sheet of paper with blank fields for certain types of data or information.
  • The document is the blank paper,but it will become a record when a manager or employee fills it out.
  • The resulting plan may be a one-off, project-specific plan or more general documentation.

Planning also leads into the following areas of product realization (doing the job):

Requirements For Products And Services

  • The requirements for products and services help regulate,maintain and control the quality of a products or service,ensuring it’s consistency and meeting customer requirements.


  • The purpose of the Design and Development Procedure is to ensure that all design and development interfaces among different organizational functions and groups are defined and properly managed to ensure effective communication and clear assignment of responsibility.


  • Supplier evaluation
  • Purchase Orders
  • Goods receipt checks

Process control

  • Control of Product and Service Provision requires your organization to control the manner in which products are produced and the services provided.


  • The process of monitoring and measuring resources ensures conformity for all products and services.
  • This includes making sure that all equipment is valid,up to date, calibrated and working properly.

Read also: Phases of a Technology Transfer Project in Pharmaceutical Industry

Resource Person: Barbara Pirola

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