Foundations of Quality Management System According to ISO 9001-2015- .Process Approach And PDCA Cycle
In Foundations Of Quality Management System - module (1) show the history of ISO revisions and fundamental concept in ISO 9001:2015. In this module we will discuss Process Approach And PDCA Cycle.
Process Approach and PDCA Cycle
A process is usually defined as reproducible,
interacting activities that together convert an input into an output. The
elements in the process approach cycle are discussed below:
- With What means the infrastructure i.e. process equipment, software, hardware, and supporting devices.
- With Who means the human resource i.e. personnel, training, and qualification needed to carry out the process.
- How is the procedure or work instructions that explain how the process will be carried out and describe the entities responsible entities for the process.
- How many? These are the process monitoring parameters like action plan, trends, production reports.This also counts as evidence for PDCA.
- Input is something that starts the process. Input can be workers, event, resources, or supplies. For example, a maintenance requisition starts the process for maintenance.
- Output is a consequence of the process, or its result. Output should comply with the expectation of a customer both in-house or external. Normally outputs are goods, services, or the input into other in-house process.
The Approach Process Characteristic
Some of the process characteristics are:
-Repeatable
-Predictable
-Quantifiable
-Explainable
-Context Oriented & Dependent
Approach Process Characteristics
The application of the process approach in Quality Management System enables:-
- Understanding and consistency in meeting requirements.
- The consideration of processes in term of add value.
- The achievement of the effective process performance.
- Improvement of processes based on evaluation of data and information.
What is PDCA cycle
Plan-Do-Check-Act (also known as
“PDCA”) is a cyclic process that was conceptualized by Walter Shewhart and
widely promoted by Edward Deming – two founders of most of the quality
philosophies that are followed today.
Approach Process Characteristics
Plan, Do, Check &
Act is a cycle that was devised by Walter Shewhart and propagated by Edward
Deming. PDCA is an iterative four-step managing technique utilized in industry
for the continual improvement of processes.
Plan
– This
step includes the establishment of the objectives and processes essential to
provide outcomes that are in line with needed output.
Planning of the QMS starts with the initial documentation of
the Quality Manual, control of documents and records, Quality Policy and
Quality Objectives, plan to achieve policy & objectives, Additional
planning on how to realize the product or service, including what resources are
required and how they will be used, is the last step in the early planning.
Do – This step includes the execution of the
plan, performance the process, and production the product. At this point,
companies must gather process statistics for recording and examination in the
next steps of Check and Act.
Raw material or
service needs must be specified.
Designs development,
the purchasing process, and raw materials must be verified against
requirements.
The process of
creating the merchandise or service must be implemented. Defects must be
incorporated in non-conformists and be dealt with. The procedure and the
instrument to monitor and inspect the product and processes must be controlled.
All undertakings of
creating and delivering the product or service to clients are required to be
completed in Do phase.
Check – Examine the real results of ‘Do’ step
and check it against the expected results of the plan phase.
It is mandatory to
check and measure not merely the product to make sure it fulfills requirements,
but moreover to check and measure the processes as well. Analysis of data,
internal audits, external audits & Management Review are mandatory in ISO
9001. All these extensive processes are part of ‘check’ phase in PDCA
cycle.
Act – If the Check analysis reveals
that the Plan that was applied in Do phase is
a progressive improvement to the earlier results, then the present ‘Do’ should
become the new standard for how the organization should Act going
forward.
If the Check analysis
reveals that the Plan that was applied in Do phase
is not an improvement, then the prior standard will remain.
In both cases, i.e.
improvement or no improvement, more learning is needed and that will inform
next PDCA cycle. Corrective actions and action plans that resulted from output
of management review meetings and internal audits are part of the Act phase
in PDCA cycle.
When to Use Plan–Do–Check–Act
PDCA cycle should be used in following cases:
When opting for continuous improvement.
When initiating a new improvement project.
When making a new or modified design of a process, product
or service.
When defining a repetitive work process.
When preparing data collection and analysis so as to verify
and prioritize problems or root causes.
When applying any change.
PCDA can applied to all processes and QMS as whole.
Plan and Do in ISO 9001:2015
Planning is one of the
vital parts of the QMS and begins with realizing the context of
the organization and the expectations of interested parties (Clauses 4.1 &
4.2), which is then utilized to define the QMS scope and the processes (Clauses
4.3 & 4.4).
Then commitment
of leadership in the company guides the organization to a customer
focus by outlining organizational roles and responsibilities and by instituting
a quality policy to focus on QMS (Clauses 5.1, 5.2 & 5.3).
Then planning identifies
and addresses the risks and opportunities of the QMS, including
setting and planning for quality objectives and changes to support continual
improvement (Clauses 6.1, 6.2 & 6.3).
The final layer of
planning is to recognize and define the support structure to
perform plans. This comprises resources (Clause 7.1), recognizing competence
(Clause 7.2), awareness (Clause 7.3), communication (Clause 7.4) and to have
the system for creation and control of documented information (Clause 7.5).
Check and Act in ISO 9001:2015
here are numerous places
in the standard to check the processes of the QMS to make sure they are
effective as per plan. The ISO standard requires enterprises to monitor,
measure, analyze and evaluate the products or services to make sure that the
processes employed are satisfactory and effective, and that customer satisfaction
is achieved (Clause 9.1). Internal Audits (Clause 9.2) are required as a means
of measuring the effectiveness of the QMS. The Management Review procedure
(Clause 9.3), analyses and evaluates all the collected information related to
QMS and helps to identify solutions to resolve any issues or problems.
Approach Process Characteristics
Approach Process Characteristics