Risks in the Quality Management System

Risks in the Quality Management System

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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