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.

Below is the exact wordings from FDA website.

21 CFR 820.20 (a)	Does management with executive responsibility establish its policy and objectives for, and commitment to, quality?
21 CFR 820.20 (a)	Does management with executive responsibility ensure that the quality policy is understood, implemented, and maintained at all levels of the company?
21 CFR 820.20 (b)	Does the company establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part?
21 CFR 820.20 (b) (1)	Does the company establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks?
21 CFR 820.20 (b) (3) (i)	Does management with executive responsibility appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part?
21 CFR 820.20 (d)	Has a quality plan been established which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured?
21 CFR 820.20 (d)	Has management established how the requirements for quality will be met?
21 CFR 820.20(e)	Has the company established an outline of the structure of the documentation used in the quality system?
21 CFR 820.5	Does the company establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part?
21 CFR 820.5(d)	Does the company establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured?
21 CFR 820.5(d)	Does the company establish how the requirements for quality will be met?
21 CFR 820.5(e)	Does the company establish quality system procedures and instructions?
21 CFR 820.5(e)	Where appropriate, has the company established an outline of the structure of the documentation used in the quality system?

Courtesy of www.mnc.umd.edu 

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.