Introduction:
Whenever in conflict of interest between
business/sales and quality/QMS, quality/QMS is not given preference the results
has been catastrophic. Compromised product quality has impact on business for
years to come.
Clause no 5, Management Responsibility
addresses the responsibilities of the management for implementation of the
effective QMS. Evidence for each of the sub clause shall be provided by the
management in an effort to implement a QMS.
ISO 9001-2008
Standard requires, “Top management shall provide evidence of its commitment to
the development and implementation of the quality management system and
continually improving its effectiveness”. The following description is designed
to provide the evidence of management’s commitment.
Quality policy +
Quality Objectives focuses & directs the organization to quality and
customer satisfaction.
| 5 | MANAGEMENT RESPONSIBILITIES |
| 5.1 | MANAGEMENT COMMITMENT |
| 5.2 | CUSTOMER FOCUS |
| 5.3 | QUALITY POLICY |
| 5.4 | PLANNING |
| 5.4.1 | Quality Objectives |
| 5.4.2 | Quality Management System Planning |
5. MANAGEMENT RESPONSIBILITIES
5.1 Management Commitment:
Top management is responsible for
management of Quality in the organization/ company. Each function/process is
controlled by a head/ lead, who are responsible for their relevant processes/ procedures/operations
in the development and implementation of Quality Management System. The responsibilities
of all the functions influencing quality standards are defined. (Refer 5.5- Responsibility, authority and
communication).
Top management is
committed to the development and implementation of QMS and continually improves
its effectiveness (to the satisfaction of customer, regulatory, stakeholders
and other interested parties) by:
- Ensuring that customer as well as regulatory and statutory requirements are understood and appropriately addressed. The staff is kept updated about customer’s expectations, evolving product & quality requirements and regulatory & statutory requirements applicable to product, process & environment and support functions. This is achieved through regular training/ briefing and other means of communications such as meetings, emails, bulletins, board postings, intranet etc.
- Defining the purpose and objectives for the quality management system. They are documented and communicated in the form of quality policy and quality objectives.
- The quality policy is adhered to and implemented in
true prospective at all levels as it emphasizes the importance of planning to
avoid quality failures and achieve organizational goal.
- The management has established quality objectives
which are measureable, includes performance indicators, reflecting requirements
for product/services, and are consistent with quality policy including the
commitment to continuous improvement. Quality objectives at functional level
are established which are monitored, analyzed and controlled to achieve desired
results.
- (Provide
evidence of communication of Quality Policy and Objectives in the form of
defined procedure or explain the process in the test as:) Quality
policy and quality objectives are printed (in English and ……….) in a booklet
and distributed in staff across the company. Quality Policy/Quality Objectives
are printed in posters for display in different locations (offices and
different sections) for continued awareness of the intent and commitment of the
management.
- The quality policy and objectives as written in this
document (cite
point no in which both are given) are
reviewed during management review meeting for its effectiveness and suitability.
- The management periodically reviews the quality management system to ensure is continuing suitability, adequacy and effectiveness. The review evaluates current status and performance of the quality system and initiates actions to maintain the effectiveness of the quality system (Refer 5.6-Management Review, Procedure for Management Review).
- The management is committed to providing resource necessary for establishing, implementing and improving the quality management system (refer point 6 Resource Management). Suitable manufacturing and testing facilities, trained personnel, conducive work environment, provision of adequate time schedules and associated facilities are provided for delivering a quality product. Adequacy of resources is reviewed during:
Management Review Meetings
Internal Departmental Meetings
Internal Audit
Any other appropriate forum
5.2 Customer Focus:
The principal objective
of the quality management system is to focus our organization on the customer,
and in particular, on determining and meeting customer requirements.
Customer satisfaction is
achieved by consistent adherence to Quality System and (write applicable national and international statutory and regulatory
requirements such as FDA, EU, WHO, MHRA etc and applicable pharmacopeia). Amendments and new
inclusions in the above requirements are adopted and system updated. A track of
new technological developments in the field is kept and reviewed for further
needs of customers with an aim to enhance customer satisfaction.
The management ensures
that customer requirements are met by inspecting and testing product at various
stages of production and upon completion.
The customer requirements
are analyzed during preliminary discussion, communication and meetings with
customer. The orders are reviewed and communicated for planning to ensure that
the product is delivered in time.
5.3. Quality policy:
Quality is responsibility
of every employee within the organization. Quality policy is established by top
management. Any changes to the policy must be likewise approved by Top
Management. The management ensures that:
-
The quality policy is appropriate to the purpose of
organizational activity of manufacturing and sale.
-
The quality policy includes the commitment to
comply with requirements and to continually improve the effectiveness of the
quality management system by employing state of the technology and teamwork of
talented and dedicated staff.
-
The quality policy provides the framework for
establishing quality objectives.
-
The quality policy is posted throughout the
company and its role is explained and discussed at the general orientation
training provided to all employees.
-
The quality policy is also communicated to
customers, consumers and other interested parties.
-
Quality policy is periodically reviewed within
the framework of management reviews of the quality system. This is to ensure
its continual relevance and suitability.
5.4 Planning:
5.4.1 Quality Objectives
Quality objectives are established to support
and implement the quality policy and continual improvement.
Quality objectives are established throughout
the organization to implement the quality policy, to meet requirements for
products and processes and to improve the quality system and quality
performance.
Quality objectives define the direction and
priorities for continual improvement. Quality objectives are measurable,
include business performance indicators reflecting requirements for
products/services and are consistent with the quality policy including the
commitment to continuous improvement.
The objectives are achievable within a time
period, and are regularly reviewed during the management review and the other
avenues of review like the weekly activity report meeting, the monthly
assessment reports review, quarterly review meetings and the bi-annual and
annual performance review.
Quality objectives are classified into the
following four categories (depending upon organizational makeup):
- Policy objectives: These are principal, strategic objectives that apply to the whole organization. They are typically included in the quality policy itself or may be communicated in memoranda from the Top Management. Policy objectives are authorized by Top Management.
- Quality performance objectives: These objectives set specific measurable targets for improving operational performance, to ensure product conformity and customer satisfaction. They apply to departments and functions having direct responsibility for activities that require improvement. Performance objectives are established, documented and monitored within the framework of management reviews of the quality system.
- Product quality objectives: These objectives pertain to improvement of products and associated services. Product objectives are established by Top Management. They can be documented in memoranda or minutes of meetings.
- Quality system objectives: These objectives pertain to improvement of quality system processes and performance. Quality system objectives are established, documented, and monitored within the framework of management reviews of the quality system.
Or
Quality objectives are classified into the
following two categories (depending upon organizational makeup):
- Policy (quality objectives): These are principal, strategic objectives that apply to the whole organization. They are typically included in the quality policy itself or may be communicated in memoranda from the Top Management. Policy objectives are authorized by Top Management.
- Function/Process Specific Objective: Quality objectives of each department/process intended for continual improvement and higher quality goals. They are defined by process lead/ departmental head and approved by Top Management. These objectives are measured in management meetings/ performance review.
5.4.2 Quality Management System Planning
Top management ensures proper planning of the
QMS to deliver the required quality products/ services to the customers.
Quality planning includes identification and determination of quality system
processes (including any exclusions of the requirements of this manual);
priorities for continual improvement; resources needed to achieve quality
objectives and to maintain and improve the quality system. Quality plans are
periodically reviewed and updated to maintain the integrity of the quality system
during organizational and other changes.
Quality system planning
Quality system elements and processes are
planned to ensure that the system is appropriate for its intended purpose and that it is
effective and efficient. The purpose of the quality system is:
- To achieve the quality policy;
- To ensure and demonstrate our ability to provide consistently product that meets customer and regulatory requirements. This includes the assessment of associated risks.
- To ensure high level of customer satisfaction;
- To facilitate continual improvement;
- To comply with requirements of Quality Manual.
Quality planning is an integral part of process and product
qualification. The activity includes identification and acquisition of any
controls, processes, equipment (including inspection and test equipment),
fixtures, resources and skills that may be needed to achieve the required
quality.
Quality planning encompasses the whole facet of operations with
focus on the following:
- Identifying of processes needed for the quality management system and their application;
- Determining the sequence and interaction of these processes;
- Determining criteria and methods needed to ensure that the operation and control of these processes are effective;
- Ensuring the availability of resources and information necessary to support the operation;
- Monitoring, measurement and analysis of these processes; and
- Implementing actions necessary to achieve planned results and continual improvement.
The output of quality system planning is
documented in quality manual, associated operational procedures and in other
referenced documents. These documents identify and define all elements and
processes of the quality system.
Changes to the quality system are planned within
the framework of management reviews. These changes may be in response to
changing circumstances, such as product, process, capacity, other operational
or organizational changes or to improve the effectiveness and efficiency of the
quality system.
Product realization and verification planning
Planning of product realization, verification
and validation processes is addressed in Section 7.1 of this manual.
Continual improvement planning
Improvements of the quality system are planned
within the framework of management reviews. The output of this planning is
expressed in the form of quality system objectives, continual improvement and
Management Review.
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