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Striving for Change
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Change (verb) = To
become different or to make somebody/something different
Change (verb) = To
become a different thing; to make somebody/something take a different form
Change (noun) = The
process of becoming or making something different
Change (noun) =
Something different
Change is brought
with improvement. The train of improvement brings the change.
ISO 9001:2015 QMS
standard strives for change, it addresses changes to the quality management
system through its requirements mentioned in a number of clauses. In this
connection, please have a look to the following clauses and their requirements:
4.4 – Continually improve
the quality management system including the processes
5.3 – The top
management of the organization needs to assign responsibilities and authorities
within the organization to ensure the integrity of the quality management
system is maintained when changes to the quality management system are planned
and implemented.
6.3 – Planning of
change – Carry out change planning in a planned manner by considering purpose
of change, potential consequences of the change, the integrity of the quality management
system, availability of resources, the allocation or reallocation of responsibilities
and authorities. This clause makes a reference of clause 4.4 of the standard.
8.1 – Operational planning
– (i) Controlled planned changes, (ii) Review the consequences of unintended changes,
and (iii) Taking necessary actions to mitigate (reduce) any adverse effects, as
necessary. (Unintended changes = Changes that are not planned or desired.)
8.3.6 – Design and
development changes – Identify, review and control (take action) design and
development changes to ensure no adverse impact on conformity to requirements. Also
need to retain documented information (records) on design and development
changes.
8.5.6 – Control of
changes – Review and control changes for production or service provision to the
extent necessary to ensure continuing conformity with requirements. Also need
to retain documented information (records) describing the results of the review
of changes, personnel authorizing the change, and any necessary action arising
from the review.
9.2 – Internal audit
– Consider importance of changes during planning, establishing and implementing
an audit programme.
9.3 – Management review
– Inputs of management review to consider external and internal issues relevant
to the quality management system. Outputs of management review include taking decisions
and actions related to any need for changes to the quality management system.
10.2 – Nonconformity
and corrective action – When a nonconformity occurs, make changes to the
quality management system, if necessary.
Thus, we see that
addressing changes becomes an increasingly important component for the quality
management system in the standard.
Changes are
inevitable. Changes are part of the system. No one can avoid changes. Changes may
be needed. Changes can be related to any elements of a process. Changes when
planned are to be beneficial. Changes need to be carried out as planned. It is
better to consider risks and opportunities associated with the change.
An organization can
have a better change management to achieve the benefits associated with
changes. The organization should consider all types of changes that may need to
happen in the quality management system. Changes may be generated in processes,
documented information, resources, competence, awareness, operation, performance
evaluation, improvement initiatives, and many more. PDCA methodology is an
effective tool for a successful change management, which may have following
steps:
· Plan – (i) Define – What needs to be changed? (ii) Determine specific
tasks, (iii) Make a plan – How to do? What resources required for the change? What
information needed for the change? Who will supervise? What will be the budget?
What will be the timeline? (iv) Develop a communication plan.
· Do – Engage people, train them, improve their awareness, knowledge and competence,
use resources and carry out the change.
· Check – Measure the effectiveness of the change
· Act – Correct and improve, if needed.
Case study –
Change in the System
Background: ABC Manufacturing’s design and development department received a
nonconformity report from its internal auditor, highlighting that a specific procedure
had not been followed by XYZ, the individual responsible for designing a
product. An enquiry into this nonconformity uncovered several key points.
Issues
identified:
1.
Lack of Procedure Awareness: It was discovered that XYZ was unaware of the newly established
procedure. When the procedure was introduced, employees were scheduled for
awareness training. Unfortunately, on the day of training, XYZ was on leave.
This situation raised to a question of why XYZ had not been sent for training
on a later date or why he had been assigned a task that required knowledge of a
procedure he was unaware of.
2.
Lack of Training: It became apparent the ABC Manufacturing’s system did not have any
documented training process in place. This lack of structured training system
was a contributing factor to XYZ’s unawareness of the procedure.
Change
Introduced: In response to the above findings and as an improvement
initiative, ABC Manufacturing’s management decided to implement a documented
training process. This change aimed to address the issue of procedure awareness
and enhance the overall competence of its employees.
Application of
PDCA Methodology
ABC Manufacturing
followed the PDCA methodology to successfully implement the change by applying
following steps:
Plan:
· Define the issue: Lack of procedure awareness led to nonconformity.
· Set objectives: Develop a documented training process
· Identify resources and stakeholders: Training institutions, trainers,
training material etc.
· Create a detailed plan: How training process will work, including scheduling,
content, reporting, assessment etc.
Do:
· Implement the training process: Employees being provided training as per
the training process. XYZ was also provided training of the specific procedure.
· Monitor progress: Track participation and evaluate the effectiveness of
the training.
Check:
· Assess the impact: Measure whether employees are having necessary
awareness, skills and competence after attending the training and their performance
and productivity impact
· Feedback: Solicit feedback inputs from employees to identify any issues
or improvements needed in the training process.
Act:
· Make improvement: Based on feedback and performance data, refine the
training process as necessary.
· Continually improve: Regularly review and update the training process to
ensure it remains effective and aligned with the needs of ABC Manufacturing.
This application of
PDCA methodology ensures that the change, in this case, the introduction of a
documented training process, is not a one-time event but an ongoing cycle of
improvement. This case study provides an example of how the
PDCA methodology can be applied in change management.
Concluding
Summary
ISO 9001:2015 QMS
standard strives for change, it addresses changes to the quality management
system through its requirements mentioned in a number of clauses. Changes are
inevitable. Changes are part of the system. No one can avoid changes. Changes may
be needed. Changes can be related to any elements of a process. Changes when
planned are to be beneficial. An organization can have a better change
management to achieve the benefits associated with changes. The organization
should consider all types of changes that may need to happen in the quality
management system. PDCA methodology is an effective tool for a successful
change management.
Best Regards,
Keshav Ram Singhal
(This write-up
is a part of a forthcoming book on ISO 9001 being written by Keshav Ram
Singhal)
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