Risks
in the Quality Management System
*********
An organization implements a quality management system (QMS) to demonstrate its ability to consistently provide products and services that meet customer and applicable legal requirements, thereby enhancing customer satisfaction. The ISO 9001:2015 QMS standard specifies the requirements for a quality management system. This standard introduced risk-based thinking to strengthen the understanding and application of the process approach. The organization needs to determine potential risks so that they can be suitably addressed in a timely and systematic manner.
In this
write-up, a few risks in a quality management system that an organization may
encounter are mentioned with examples and proposed action to address the risk
issue.
1.
Failure to achieve quality objectives
– Example may include actual product rejection rate exceeds the target limit or
customer satisfaction index falls below the planned level. Proposed action may
include reviewing objectives for realism and alignment with organizational
strategy, applying root cause analysis (RCA) and implementing corrective
actions.
2.
Slowdown in organization’s performance
– Examples may include decline in on-time delivery or productivity ratios, or
increased internal rework or waste. Proposed action in this case may be to conduct
management reviews more frequently, monitor key performance indicators (KPIs)
and initiate improvement projects, so that organization’s performance may
increase.
3.
Changes in the QMS not recognized timely – Examples may include revision of legal or ISO
requirements overlooked, process updates delayed due to lack of communication.
Proposed action may include establishing a structured change management system
and regularly reviewing applicable standards and statutory updates.
4.
Undesirable or unplanned changes in QMS – Examples may include staff making uncontrolled
document edits or process steps modified without approval. Proposed action in
this case may include applying document and configuration control procedures
and training staff on authorized change protocols.
5.
QMS inadequate to meet customer needs
– Examples may include customer complaints increase due to unmet delivery
expectations or product does not meet emerging technological requirements.
Proposed action may include periodically assess customer feedback and
satisfaction surveys and update processes and specifications in line with
customer requirements.
6.
Decisions not implemented effectively
– Examples may include management review actions left pending or audit findings
not closed in due time. Proposed action may include assigning responsibility,
timeline, follow-up mechanism and conducting periodic progress reviews.
7.
Untapped opportunities
– Examples may include neglecting automation opportunities or ignoring
potential new markets or quality improvement methods. Proposed action may
include opportunity assessment in risk management, encouraging employee
suggestions and innovation.
8.
Inadequate team formation or lack of competence – Examples may include internal
audit team lacks trained members or quality improvement team missing
cross-functional expertise. Proposed actions may include conducting skills
assessment, provide necessary training and build balanced teams with experience
and fresh perspectives.
9.
Conflicting needs and expectations of interested parties – Examples may include supplier
demands longer payment terms, while finance institution wants shorter; customer
requires faster delivery, while production capacity is limited. Proposed action
may include prioritizing actions based on risk impact and organizational goals,
communicate and negotiate realistic expectations.
10.
Breakdown of processes
– Examples may include supplier delivery failure halts production or internal
process fails due to missing inputs. Proposed actions may include identifying
process interlinks through flowcharts and FMEA, and develop contingency and
backup plans.
11.
Breakdown or malfunction of equipment
– Examples may include machine downtime affects production schedule or
measuring equipment out of calibration. Proposed actions may include following
preventive maintenance and calibration schedule strictly and maintaining
critical spares inventory and calibration register.
12.
Delay or neglect in maintenance
– Examples may include maintenance postponed due to workload pressure or maintenance
logs incomplete. Proposed action may include linking maintenance schedule with
production planning and automate maintenance reminders.
13.
Failure to meet product requirements due to poor equipment condition – Examples may include dimensional
deviation due to worn-out tools or contamination in process due to unclean
equipment. Proposed action may include periodic equipment inspection and
replacement plan, implementing 5S practices and Total Productive Maintenance
(TPM).
14.
Rising material or energy costs
– Examples may include increased energy tariffs raise product cost or raw
material wastage due to inefficient handling. Proposed action may include implement
energy management practices, as par ISO 50001 Energy Management System (EnMS),
optimize procurement and storage processes.
15.
Depreciation of equipment
– Examples may include old equipment consumes more energy and time, or obsolete
machinery leads to poor product consistency. Proposed action may include evaluating
cost-benefit for modernization and preparing equipment replacement plan.
16.
Lack of awareness among employees
– Examples may include employees unaware of quality policy, objectives or misunderstanding
of work instructions. Proposed action may include conducting awareness sessions
for the employees and display QMS policy and objectives visibly at workplaces.
17.
Ineffective internal audits
– Examples may include internal audit not covering all processes or internal audit
findings not fact-based. Proposed action may include training internal auditors,
ensuring independent and objective audit planning.
18.
Poor document and record control
– Examples may include using outdated work instructions or missing calibration records.
Proposed action may include implementing electronic document control system and
reviewing record retention schedule periodically.
19.
Insufficient management commitment
– Examples may include top management not reviewing QMS performance or lack of
resources for improvement initiatives. Proposed action may include reinforcing
leadership involvement through periodic reviews and aligning quality objectives
with business objectives.
20.
Supplier-related risks
– Examples may include supplier fails to deliver materials on time or poor
quality of incoming components. Proposed action may include evaluating and
approving suppliers based on performance and developing supplier partnership
programs.
21.
Non-compliance with statutory or regulatory requirements – Examples may include missing
safety certification for a product or ignoring environmental norms. Proposed
action may include maintaining a compliance register and assigning
responsibility for legal monitoring.
22.
Data integrity and cybersecurity risk
– Examples may include loss of records due to system crash or unauthorized
access to QMS documents. Proposed action may include regular data backups, implementing
cybersecurity protocols, access control and strengthening record control.
23.
Ineffective communication
– Examples may include miscommunication between design and production or customer
complaint not escalated timely. Proposed action may include defining clear
communication channels and regular meetings for updates.
24.
Inadequate corrective and preventive action (CAPA) – Examples may include repeated
nonconformities due to poor root cause analysis or actions not verified for
effectiveness. Proposed action may include to train staff on root cause
analysis tools (5 Whys, Fishbone Diagram) and monitor CAPA effectiveness during
management review.
25.
Organizational culture resistant to change – Examples may include employees reluctant to adopt
new procedures or improvement ideas not accepted by them. Proposed action may
include promoting quality culture through recognition and participation and engaging
employees in decision-making and improvement activities.
Determining and addressing risks in the quality management system is vital for
maintaining consistency, enhancing customer satisfaction, and achieving
continual improvement. A proactive approach — integrating risk assessment into
daily operations — enables an organization to transform risks into
opportunities for growth and excellence.
The
above points highlight key risks that organizations may face while implementing
or maintaining a quality management system (QMS). Awareness and timely action
can prevent potential failures and foster a culture of quality improvement
across all levels.
Best
wishes,
Keshav Ram
Singhal
