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Wednesday, 4 December 2013

QM: 5.6 Management Review (5.6.1, 5.6.2 & 5.6.3)


5.6 MANAGEMENT REVIEW
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output

5.6 Management Review:

5.6.1 General

Top Management reviews quality system periodically (annually once) to ensure its continual suitability & effectiveness in satisfying the requirements Quality Management System and organization’s quality policy & objectives. More frequent reviews are scheduled in periods when organizational, technological, product, or other changes require increased attention and input from the top management.
The purpose of management review meetings is to:
  •           Evaluate the suitability, adequacy and effectiveness of the quality system;
  •           Consider changes to the quality management system, to the quality policy and quality objectives;
  •           Identify opportunities for improvement of the quality system, processes and products.
These reviews help in planning for organizational growth, innovation, adoption of new technologies and methodology for better productivity etc to achieve better customer satisfaction.       

The records of management meetings (Minutes of the Management Review Meetings), decisions taken and implementation are preserved (cite Procedure of Management Review).

5.6.2 Review input

Input into the management reviews consists of information and data related to quality performance of the organization. At a minimum, this includes:
  •           Issues related to quality policy and objectives and continual suitability of Quality Management System,
  •           Achievement of Quality objectives,
  •           Company level quality data,
  •           Results of audits,
  •           Customer feedback and complaints,
  •           Process performance and product conformance data,
  •           Review all preventive/corrective actions and its effectiveness of the quality system,
  •           Changes that could affect the quality system,
  •           Follow-up actions from earlier management reviews,
  •           Recommendations for improvement,
  •           Performance of suppliers,
  •           Audit schedule for next period as identified from the review,
  •           Training Requirements,
  •           Environmental, Health and  Safety ,
  •           New product development activities and status of process design & development.

The review shall evaluate current status and performance of the quality system and initiates actions for further improvement of the system.

5.6.3 Review Output
The outputs of the management review meeting typically include any decisions and actions related to:
  •           Improvement of the effectiveness of the quality management system and its processes,
  •           Improvement of product related to customer requirements, and
  •           The review also identifies resources needed to implement these actions.


Results of management reviews are documented in the minutes of the review meeting. The minutes include improvement actions, assign responsibilities and allocate resources for implementation of these actions and their due dates. 

Figure 6 Cycles of continual improvement. (http://www.ifcc.org/ifcc-communications-publications-division-(cpd)/ifcc-publications/ejifcc-(journal)/e-journal-volumes/ejifcc-2004-vol-15/v/iso-15189-2003-from-theory-into-practice/)

Monday, 2 December 2013

QM: 5.5 Responsibility, Authority and Commitment (5.5.1, 5.5.2 & 5.5.3)

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
5.5.1 Responsibility and Authority
5.5.2 Management representative
5.5.3 Internal Communication


5.5 Responsibility, Authority and communication

Functions and their interrelation within company are defined and communicated.
Top management appoints a management representative responsible for establishment and maintenance of the quality system, and for reporting to the top management on the performance of the system.
Issues regarding the quality system are communicated internally though distribution of pertinent documents, meetings, training and awareness programs, and management reviews.

5.5.1 Responsibility and authority

All departments and functions in the company are responsible for implementing, maintaining, and improving the quality system.
Responsibilities & authorities and interrelation of personnel in the organization are defined in organizational charts, policies and procedures, as well as in job descriptions/ responsibilities. Job descriptions/ responsibilities define the responsibilities and authorities of each of the positions on the organizational chart. Job descriptions and the organizational chart are reviewed and approved by top management for adequacy.

Top Management sets direction and ensures the success of Organization. Top Management
• Formulates the quality policy
• Provides resources necessary to maintain and improve the quality system
• Conducts management reviews of the quality system

Departmental heads (Production, Purchasing, Quality Assurance, Quality Control, Engineering, Marketing and Sales, Material Management, Logistics/Shipping, Administration, Accounting, Contracting), while under the direction of the top management, have primary responsibility for all operations under their control, including the Quality Management System described herein. Departmental Heads, Managers, In-charges and supervisors, who manage, perform and verify work affecting quality, at various levels are responsible, and have authority within their defined areas of control as follows –
  •           To initiate action to prevent the happening of any non-conformity of the product, process or quality system.
  •            To identify and record any problem of the product, process and quality system.
  •            To initiate, recommend or provide solutions.
  •           To check the effectiveness of solutions.
  •           To control further action on the non-conforming product / process till the deficiency has been corrected.
  •           The quality of work carried out by personnel in their department.


All employees are responsible for the quality of their work and for their part in the overall processes used to provide products, information and services to our customers. Employees identify and record any problems related to the product, process, and quality system. Employees are also the key participants in process improvements and the identification of measures needed to ensure the success of our continual improvement processes.

In the event of absences, responsibility and authority passes on to the next higher level of management.

5.5.2 Management Representative

Top Management assigns the responsibilities & authorities of the MR, during his absence, to a nominated person. These responsibilities are additional to his normal responsibility already assigned to him.

The Management Representative has the organizational freedom and unrestricted access to top management to resolve quality management issues.

Included, but not limited to his/her responsibilities are:
  •           Ensure that the quality management system is implemented, maintained and continually improved (as per ISO 9001:2008);
  •           Promote awareness of customer requirements throughout the organization;
  •           Plan and conduct Management Review Meetings
  •           Reports to the Top Management on the performance of the quality system, including needs for improvement;
  •           Ensure promotion of awareness of customer requirements throughout the company
  •           The Management Representative will coordinate communication with external parties on matters relating to the quality system.
  •           Bring out new revisions whenever a number of changes are made in the manual & documents in consultation with the Top Management.

       In addition, the Quality Management System Representative is responsible for reporting to Executive Management Team on the performance of the QMS, ensuring the promotion of awareness of regulatory and customer requirements throughout the organization, and ensuring that the performance of the system is reviewed as a basis for continual improvement.

5.5.3 Internal Communication

Internal communication regarding the quality system flows two ways:
·          The management communicates to the organization the quality policy and objectives; customer and regulatory requirements; product and process specifications; verification and validation requirements; and instructions on how to implement and use the quality system.
·          The organization communicates to the management information and data regarding customer needs and expectations, customer satisfaction, quality performance, the effectiveness of the quality system and opportunities for improvement.

The information is communicated through:
·          Paper or electronic documents, such as manuals, procedures, instructions, drawings, specifications, quality records, reports, etc.;
·          E-mails, memos, and meetings;
·          Training and awareness programs; and
·          Employee suggestions, surveys and feedback.

Management review meetings have a special role in ensuring proper communication between the top management and the organization. The meeting provides the framework for the organization to report on the status of quality-related issues and activities, and for the management to formulate and communicate policies and directives to change and/or improve the quality system.


QA Manager has the overall responsibility for ensuring that all pertinent documents, reports and records are distributed to appropriate departments and functions, and that information and data about quality performance and the effectiveness of the quality system are reported to the top management.