Nonconformity (NC) is defined as the non-fulfillment of a requirement (ISO 9000: 2015). The requirement could be from a specification, a standard, need or an expectation that is stated or implied.
Nonconformities are detected through audit, inspection, document adequacy review, checks / tests, customer or stakeholder complaints / feedback, general observations / experience etc.
Nonconformities could involve:
- Failure to - identify issues / include in QMS / define process / plan / schedule
- Procedural / process deviation
- Control / indication failure / error
- Failure to implement instructions
- Product characteristic deviation from specification
- Product defect / defective product
- Missed plan / schedule implementation
- Customer complaint – product / service / delivery etc.
- Customer return, recall
- Supplier return, recall
- Legal / statutory / regulatory / other non-compliance
- Any other, specific to organization / business
As with the other processes in a quality management system (QMS), nonconformity management is also done through a process approach. A step-wise process approach could include:
- Identification, acceptance by Auditee, recording NC in the appropriate format
- Cause analysis – assess and determine the causes (and to the underlying causes, to the extent possible)
- Impacts of the nonconformity – assess the likely impacts on the overall system, process, product, service, customer, equipment etc.
- Prioritize / rate the impacts based on potential loss - product safety, performance failure, usage, reliability, maintainability, cost, time
- Identify the actions for NC close-out – immediate, short-term, medium-term, long-term, as applicable
- Actions for correction, concession, rejection, corrective action (elimination of cause – if feasible), sk treatment to eliminate / minimize residual risk
- Implement the identified actions, with adequate monitoring, review, evaluation as required by QMS
- Report the actions (in conformance with QMS / customer expectations):
- Correction – actions of rectification, repair, rework, restoration, replacement
- Concession action, with approval of customer
- Corrective action
- Others, as applicable
Nonconformities, whether closed or open, are assessed during management reviews, to lead the organization towards continual improvement.
For obvious reasons, the NC management must be planned and executed in tune with organization’s size, location, type of activities, best available technology, practicality / feasibility, urgency, resources, customer / stakeholder / societal expectations etc.
NC management process as part of the QMS, needs to focus on:
- Prompt actions
- Efforts to prevent / minimize recurrence
- Actions to identify / prevent / minimize potential NC
- Avoid / minimize business loss – time, resource, cost, re-work, rejection, return, recall
- Customer satisfaction, other stakeholder satisfaction if need be
- Market / social reputation
- Organization-specific policies and strategies
An efficient and effective non-conformity management process will add enormous value for the management system of every organization.