ISO
9001:2015 QMS Awareness – Planning
===========
Why the planning step important in a quality management
system?
Planning
in ISO 9001 QMS is the method of deciding what's most important and most
critical aspects to the ISO 9001:2015 QMS during the planning stage, so we can
make sure that everything goes according to plan.
Here
are some points highlighting the importance of planning in a quality management
system (QMS):
(1)
Planning ensures consistency. Planning helps to establish a consistent approach
to quality management system by determining the activities, processes, and
resources required to achieve desired outcomes / results.
(2)
Planning helps in managing risks. Through planning, potential risks and
opportunities can be determined and addressed proactively, reducing the
likelihood of quality issues and nonconformities.
(3)
Planning helps in defining objectives and targets. Planning enables
organizations to set objectives and targets for their QMS that are aligned with
their overall business strategy, ensuring that quality is embedded in all
aspects of the organization.
(4)
Planning helps in resource allocation. Planning helps to ensure that resources,
including time, money, personnel and infrastructure, are allocated efficiently
and effectively to achieve desired outcomes.
(5)
Planning facilitates continuous improvement. By establishing a framework for
planning, monitoring, and evaluating quality activities, planning can help to
identify areas for improvement and enable organizations to continually enhance
their QMS.
Overall,
planning is a critical component of a quality management system (QMS), helping
organizations to achieve consistent, efficient, and effective quality
management practices while enabling continuous improvement over time.
Requirements for planning
Requirements for planning are mentioned in
clause 6 of ISO 9001:2015 QMS standard. The relevant sub-clauses of Clause 6 of the standard are as
under:
6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve
them
6.3 Planning of changes
Actions to address risks and opportunities
The organization needs to consider determined
external and internal issues related to the organization and its context and
determined needs and expectations of interested parties as determined in terms
of clause 4.1 and clause 4.2 of the standard.
The organization needs to determine risks and
opportunities that need to be addressed to give assurance that the quality
management system of the organization can (1) achieve organization’s intended
results, (2) enhance desirable effects, (3) prevent or reduce undesirable effects,
and (4) achieve improvement.
The organization needs to plan: (1) Actions to
address determined risks and opportunities, (2) Procedure / way to integrate and
implement planned actions into the organization’s quality management system
processes, (3) Procedure / way to evaluate effectiveness of planned action.
The organization needs to ensure that the
actions taken to address determined risks and opportunities must be
proportionate to the potential impact on product / service conformity.
Here while implementing above requirements, we
must understand that options to address risk may vary, such as, avoiding the
risk, converting the risk into opportunity, eliminating risk source, changing
the likelihood or consequences, risk sharing, retaining risks by informed
decisions. Opportunities can lead to something better, such as, adopting new
practices, launching / introducing new product / service, opening new markets, addressing
new clients / users, building partnerships using new technology, other
desirable and viable possibilities to address needs of the organization or
customer.
A few real-life examples to address risk are given
below:
Avoiding the risk into opportunity – A
restaurant may avoid the risk of losing customers and low sales during slow
business periods by offering special promotion deals to attract new customers
and increase sales.
Eliminating risk source – A manufacturer may eliminate
risk source of producing defective product by finding out the risk source by
implementing monitoring and measuring control processes at every stage of
production.
Changing the likelihood or consequences – An
airline company may change the likelihood of flights’ delay by better
maintenance and repair of their aircrafts and hiring of trained skilled pilots
and ground staff.
Risk sharing – A company may share the risk of
project’s delays and cost overruns with their subcontractors by including
penalty clause in their contracts.
Retaining risk by informed decision – A hospital
may choose to retain the risk of treating a high-risk patient with a complex
medical condition by conducting thorough medical check-ups, assessments and
consultations with specialists and such risk is informed to the patient party. Quality
Quality objectives and planning to achieve them
Objective = Something that the organization is
trying to achieve = Aim
Quality objectives are specific, measurable
goals that an organization sets to improve its quality management system. Quality
objectives are typically derived from the organization's quality policy and are
aligned with its strategic objectives. Businesses use quality objectives to
improve their products, services, and operations.
The organization needs to establish quality
objectives at relevant functions, levels and determined processes needed for
the quality management system.
The organization needs to ensure that quality
objectives must be consistent with the quality policy, measurable, take into
account applicable requirements, relevant to product / service conformity,
relevant to customer satisfaction enhancement.
To achieve established quality objectives, the
organization needs to determine:
(1) Ways, procedures and processes,
(2) Resource needs,
(3) Personnel responsible,
(4) Time targets for completion,
(5) Evaluation method / procedure
The organization needs to communicate the established
quality objectives to relevant personnel.
The organization needs to monitor the
established quality objectives.
The organization needs to update the
established quality objectives, as appropriate.
The organization needs to maintain a documented
information (document) on quality objectives.
Planning for changes
The organization needs to consider:
(1) Purpose of change,
(2) Potential consequences of the change,
(3) quality management system integrity,
(4) Availability of resources,
(5) Allocation / re-allocation of responsibilities
and authorities.
The organization needs to carry out change in a
planned manner. (Please also refer to clause 4.4 of the standard.)
A change to a quality management system may be
a result of anything from customer complaints or product failures to identified
opportunities for improvement or innovation. Change management is a systematic
approach to dealing with such change. Please also read a write-up on “Change
management in ISO 9001:2015 QMS”.
Think of
the following Questions
(i)
What
are the requirements for planning in clause 6 of ISO 9001:2015 QMS standard?
(ii)
What
actions will you plan to address risks and opportunities in the quality
management system of an organization?
(iii)
Why
quality objectives necessary for a quality management system?
(iv)
Why
change is needed for the quality management system?
Best wishes,
Keshav Ram Singhal
Please have your comments /
reaction.
To train your employees with ISO
9001:2015 QMS Awareness, please supply them “TRAINING HANDBOOK ON ISO 9001:2015QMS AWARENESS” (ASIN:
B093YFFY7Z), which is available worldwide at Amazon. Please
search this Training Handbook in Amazon Website of your country.
You may also supply your
employees following eBooks - (i) A Concise Guide on Creating and Updating Documented Information
(eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-concise-guide-creating-and-updating-documented-information/
(ii) Applying Risk-based Thinking in an Organization Implementing ISO
9001:2015 QMS (eBook) https://store.pothi.com/book/ebook-keshav-ram-singhal-applying-risk-based-thinking-organization-implementing-iso-9001-2015-q/
Thanks.
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