Q5. Suppose that you are working in an organization, which wants to develop an effective implementation methodology for ISO 9000 Quality Management System. How will you help your organization in developing an effective implementation methodology?
Ans. ISO 9001:2008 states:
In sub clause 0.1 General: “The design and implementation of an organization‘s quality management system is influenced by: its business environment, changes in that environment, or risks associated with that environment; its varying needs; its particular objectives; the products it provides; the processes it employs; its size and organizational structure. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation”.
In sub clause 0.2 Process Approach: “The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“.
In sub clause 4.1 General requirements: “The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall:
a) Determine the processes needed for the quality management system and their application throughout the organization
b) Determine the sequence and interaction of these processes,
c) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e) Monitor, measure (where applicable), and analyze these processes,
f) Implement actions necessary to achieve planned results and continual improvement of these processes.
These processes shall be managed by the organization in accordance with the requirements of this International Standard”.
Based on the above, each organization should define the number and type of processes needed to fulfill its business objectives. It is permissible for a process that is required by ISO 9001:2008 to be part of a process (or processes) that is already established by the organization, or to be defined by the organization in terms that are different to those in ISO 9001.
Implementation Methodology
The following implementation methodology can be applied to any type of process. The step sequence is only one method and is not intended to be prescriptive. Some steps may be carried out simultaneously.
1. Identification of processes of the organization
(a) Define the purpose of the organization
The organization should identify its customers and other interested parties as well as their requirements, needs and expectations to define the organization's intended outputs.
Gather, analyze and determine customer and other interested parties requirements, and other needs and expectations. Communicate frequently with customers and other interested parties to ensure continual understanding of their requirements, needs and expectations.
Determine the requirements for quality management, environmental management, occupational health and safety, management, business risk, social responsibilities and other management system disciplines that will be applied within the organization.
Determine the requirements for quality management, environmental management, occupational health and safety, management, business risk, social responsibilities and other management system disciplines that will be applied within the organization.
(b) Define the policies and objectives of the organization
Based on analyses of the requirements, needs and expectations, establish the organization's policies and objectives
Top management should decide which markets the organization should address and develop relevant policies. Based on these policies, management should then establish objectives for the intended outputs (e.g. products, environmental performance, occupational health and safety performance)
(c) Determine the processes in the organization
Determine all the processes needed to produce the intended outputs. Determine the processes needed for achieving the intended outputs. These processes include Management, Resources, Realization and Measurement, Analysis and Improvement.
Identify all process inputs and outputs, along with the suppliers, customers and other interested parties (who may be internal or external).
Define and develop a description of the network of processes and their interaction. Consider the following: the customer of each process, the inputs and outputs of each process, which processes are interacting, interfaces and what are their characteristics, timing and sequence of the interacting processes, effectiveness and efficiency of the sequence.
(d) Determine the sequence of the processes
Determine how the processes flow in sequence and interaction. Assign responsibility and authority for each process.
Management should define individual roles and responsibilities for ensuring the implementation, maintenance and improvement of each process and its interactions. Such an individual is usually referred to as the "process owner". To manage process interactions, it may be useful to establish a "process management team", that has an overview across all the processes, and which includes representatives from each of the interacting processes.
(e) Define process documentation
Determine those processes that are to be documented and how they are to be documented.
The main purpose of documentation is to enable the consistent and stable operation of the processes. The organization should determine which processes are to be documented, on the basis of:- The size of the organization and its type of activities, The complexity of its processes and their interactions, The criticality of the processes, and The availability of competent personnel.
2. Planning of a process
(a) Define the activities within the process
Determine the activities needed to achieve the intended outputs of the process. Define the required inputs and outputs of the process. Determine the activities required to transform the inputs into the required outputs. Determine and define the sequence and interaction of the activities within the process. Determine how each activity will be performed.
(b) Define the monitoring and measurement requirements
Determine where and how monitoring and measuring should be applied. This should be both for control and improvement of the processes and the intended process outputs. Monitoring is always applicable but measurement may not be practicable or even possible. Nevertheless measurement gives more objective data on the performance of the process and it is a powerful management and improvement tool.
Identify the measures and monitoring criteria for process control and process performance, to determine the effectiveness and efficiency of the process, taking into account factors such as: Conformity with requirements, Customer satisfaction, Supplier performance, On time delivery, Lead times, Failure rates, Waste, Process costs, Incident frequency.
(c) Define the resources needed
Determine the resources needed for the effective operation of each process
(d) Verify the process and its activities against its planned objectives
Confirm that the characteristics of the processes are consistent with the purpose of the organization.
3. Implementation and measurement of the process
Implement the processes and their activities as planned.
Apply the controls, and perform the monitoring and measurements as planned.
4. Analysis of the process
Analyze and evaluate process information obtained from monitoring and measuring data, in order to quantify process performance. Where appropriate, use statistical methods.
Compare the results of process performance information with the defined requirements of the process, to confirm process effectiveness and efficiency and to identify any need for corrective action.
Identify process improvement opportunities based on the results of the analysis of process information.
Report to top management, and other relevant people in the organization, on the performance of the process, as appropriate.
5. Corrective action and improvement of the process
Whenever corrective actions are needed, the method for implementing them should be defined. This should include the identification and elimination of the root causes of the problems (e.g. errors, defects, lack of adequate process controls). The effectiveness of the actions taken should be reviewed. Implement the corrective actions and verify their effectiveness according to plan.
When planned process outcomes are being achieved and requirements fulfilled, the organization should focus its efforts on actions to improve process performance to higher levels, on a continual basis.
The Plan-Do-Check-Act (PDCA) methodology can be a useful tool to define, implement and control corrective actions and improvements. The PDCA is a dynamic methodology that can be deployed within each of the organization’s processes and across their interactions. It is intimately associated with planning, implementation, verification and improvement.
Maintaining and improving process performance can be achieved by applying the PDCA concept at all levels within an organization. This applies equally to all processes, from high-level strategic processes to simple operational activities.
No comments:
Post a Comment