Quality Objectives

This blog and the subsequent few dozen blogs will discuss the key quality requirements of EU medical device regulation, the ISO 13485. This blog is about quality objectives.

A procedure for ‘quality objectives’ is to provide a system and instructions, and to assign responsibility for the initiation, implementation and monitoring to achieve quality objectives in the organization. The objective of this procedure is to improve the quality of the products, manufacturing and support processes and the entire quality management system.

1)    Establishment of Quality Objectives in the Organization:

The quality objectives are established to improve the performance and quality system in order to achieve the quality policy, organizational goals and objectives.

New quality objectives can be established and recorded at the management review.  Management review and the process is discussed in another blog.

For each quality objective, the QA Manager shall establish a quality objective record. The following information should be in the quality objective.

·       Quality objective to be achieved by the project.

·       The present level of the objective and the performance level to be achieved. (For example, at present, there are 30 CAPAs generated each month and in 12 months, the goal of the quality objective is to reduce by 50%, therefore only 15 CAPAs or less can be generated.

·       A target date or time-frame must be in the quality objective. Try as hard as possible to achieve within the target date. Should an extension be made, ensure to record the justification as to why the extension is warranted.

·       The assignment of personnel like project manager and human and financial resources must also be clearly stated in the quality objective. How many personnel required to complete the quality objective on time like the hiring of consultants, additions of full time employees and how much money be allocated in the project must be clearly stated and justified.

2)    Implementation of Project to achieve the Quality Objective

 The next phase is the implementation which is the hardest portion. Project
       manager must garner support from all related departments to ensure the
       seamless execution and implementation of the quality objective.  After the
       quality objective is bought in by all related departments, QA manager will
       have to initiate the following:

·       The identification of the major elements and phases of the project; areas where the project to be implemented; other departments’ involvement, managers; requirement for personnel, facilities, equipment and other resources must be clearly identified and stated in the quality objective.

·       Monitoring and measurement methods and means to be used to measure the progress toward the underlying objective. Interim progress, problems, issue and state of the project must be periodically assimilated to all involved with the project.

·       QA manager should prepare intermediate reviews and distributed to all related personnel. Should there be any adjustment like additional resources, more personnel required; these shall be discussed in the meeting and reported in the interim report.

·       The establishment of a special project file to organize associated documents and records like interim reports, data sheets and meeting minutes. A special folder in the computer should be established and collect all documents and organized them well in the folder. For hardcopy, a special cabinet shall be provided to collect them in a logical and chronological manner.

3)    Review and Close-out of Quality Objectives

After the quality objective is achieved, the result should be reported to the management review. The closing out of the project is recorded in the closeout of the management review and shall be documented in the Quality Objective Record. All documents either virtual or hardcopies shall be updated in the folder and specific cabinet.

Reference	Criteria
ISO 13485 5.4.1	Has top management ensured that quality objectives, including those that are needed to meet requirements for product, are established at relevant functions and levels within the company?
ISO 13485 5.4.1	Are the quality objectives measurable and consistent with the quality policy?
ISO 13485 5.4.2.a	Has top management ensured that the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives?
ISO 13485 5.4.2.b	Has top management ensured that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.