Non-conformance

(NC)

Created by
Mahesh Uppara
 What is
Non-conformance?
Non-conformance
means a situation
where a product,
process, or service does
not meet the required
standards,
specifications, or
expectations.
Factors influencing
Non-conformance
Human Factors
Regulatory Compliance
Supply Chain Issues
Design Complexity
Poor Process Controls
Equipment or Machinery
Malfunctions
Documentation Errors
Environmental Conditions
Poor Quality Management
System
Inadequate Risk Management
Lack of Continuous Improvement
Culture
External Influences (Economic,
Political, etc.)
Non-Compliant Materials or
Components
 Types of
Non-conformances
Non-conformances can occur at any
stage of a product's life cycle, from its
initial design and development to its
end-of-life phase.
Product Non-Conformance
Process Non-Conformance
Documentation Non-Conformance
Material Non-Conformance
Regulatory Non-Conformance
Service Non-Conformance
Design Non-Conformance
Training Non-Conformance
Audit Non-Conformance
Safety Non-Conformance
Compliance Non-Conformance
Equipment Non-Conformance
Environmental Non-Conformance
Customer Complaint Non-
Conformance
Software Non-Conformance
 Steps to Manage
Non-conformance
1. Identification of Non-
Conformance
2. Documentation and
Recording
3. Evaluation and
Severity Assessment
4. Root Cause Analysis
5. Corrective Actions
6. Preventive Actions
7. Implementation and
Verification
8. Review and Closure
 Stakeholders
Stakeholder Responsibility

Oversight and
Management
decision-making

Compliance
Quality Team monitoring and
control

Process execution and

Production Team
adherence

Engineering Root cause analysis

Team and solutions

Feedback sharing and

Customer
satisfaction

Compliance
Regulatory
assessment and
Authority
review

Material quality and

Supplier
conformance

Inspection and
Audit Team
validation checks
Case Study: Product
Non-conformance

Identifying: During quality testing, a

pacemaker exhibits inconsistent
pacing rates, affecting its intended
functionality.
Documenting: The non-conformance
is documented, including the specific
issue, serial number, and testing
date.
Investigating: Root cause analysis
reveals a software glitch in the
pacemaker's programming
algorithm.
continued..
Corrective Action: Software
engineers develop and implement a
software update to rectify the pacing
issue.
Verification: Updated pacemakers
undergo rigorous testing to ensure
proper pacing functionality.
Preventive Measures: Improved
software validation processes are
established to prevent similar issues
in future models.
Documentation and Communication:
The non-conformance report and
corrective actions are communicated
to regulatory authorities and
healthcare providers.
Improvement: Continuous
monitoring of pacemaker
performance and feedback from
users contribute to ongoing product
enhancement.
Where NCs could
be documented?

Non-Conformance Report
Forms
Corrective and Preventive
Action (CAPA) System
Quality Management Software
Document Control Systems
Root Cause Analysis (RCA)
Documentation
Audit Reports
Incident/Issue Logs
Customer Complaint
Management System
 NC Tools

Company Name Tool Name

MasterControl MasterControl

Sparta Systems TrackWise

ETQ ETQ Reliance

AssurX Manufacturing
AssurX Quality Management
Software

Greenlight Guru QMS Software

IQS IQS Trubox

Ideagen Q-Pulse

ComplianceQuest ComplianceQuest

Qualio Qualio eQMS

QT9 QT9 QMS

 Standards
ISO standards and the
respective clauses addressing
non-conformance
(few standards)

ISO Standard Clause

Clause 10.2 -
ISO 9001:2015 Nonconformity and
corrective action

Clause 8.3 - Control of

ISO 13485:2016
nonconforming product

Clause 10.2 -
Nonconformity,
ISO 14001:2015
corrective action, and
preventive action

Clause 10.2 -
ISO 45001:2018 Nonconformity and
corrective action
 Various Industries and
Standards/Regulations
Industry Standard/Regulation Subpart (Clause)

Subpart I & J -
Section 820.90 &
FDA 21 CFR Part 820 - 820.100 -
Medical Devices Quality System Nonconforming
Regulation product, and
Corrective and
preventive action

FDA 21 CFR Part 211 - Subpart J -

Current Good Records and
Pharmaceuticals Manufacturing Reports (may
Practice for Finished include NCR
Pharmaceuticals documentation)

Clause 8.7 -
AS9100 - Quality
Nonconformity,
Management
Aerospace Corrective Action,
Systems - Aerospace
and Preventive
Requirements
Action

IATF 16949 - Quality

Clause 10.2.1 -
Management System
Nonconformity,
for Automotive
Automotive Corrective Action,
Production and
and Preventive
Relevant Service
Action
Parts Organizations

ISO 45001:2018 -
Occupational health
Clause 10.2 -
and safety
Occupational Nonconformity
management
Health and Safety and corrective
systems -
action
Requirements with
guidance for use
 Root-cause
Analysis Tools
5 Whys: A simple and effective technique
that repeatedly asks "why" to identify the
underlying cause of a problem by drilling
down to its root cause.
Fishbone Diagram (Ishikawa Diagram):
A visual tool that helps identify potential
causes of a problem by categorizing
them into major categories such as
people, processes, equipment, etc.
Failure Modes and Effects Analysis
(FMEA): A systematic approach to
identifying potential failure modes and
their impact, facilitating proactive risk
mitigation.
Pareto Analysis: A technique that
prioritizes potential root causes by
identifying the most significant
contributors to the problem based on
their occurrence frequency.
Fault Tree Analysis (FTA): A method
used to identify the combination of
events that could lead to a specific failure
or problem, revealing potential root
causes.
 Top 10 Tips
Understand the Process: Familiarize
yourself with the non-conformance and
corrective action processes to ensure
compliance and effective
implementation.
Clearly Define Roles: Assign clear
responsibilities to team members
involved in NCR and CAPA projects to
avoid confusion and ensure
accountability.
Conduct Root Cause Analysis:
Thoroughly investigate the root causes
of non-conformances to address
underlying issues and prevent
recurrence.
Set SMART Objectives: Define Specific,
Measurable, Achievable, Relevant, and
Time-bound (SMART) objectives for
corrective actions to track progress
effectively.
Implement Preventive Actions: Identify
potential risks and implement
preventive measures to mitigate future
non-conformances proactively.
Regularly Monitor Progress:
Continuously track and report on the
status of NCR and CAPA projects to
ensure timely completion.
Foster Collaboration: Encourage
open communication and
collaboration among team members
to facilitate problem-solving and idea
sharing.
Review Lessons Learned: Analyze
completed NCR and CAPA projects to
identify improvement opportunities
and apply lessons learned in future
projects.
Document Everything: Maintain
comprehensive documentation of all
NCR and CAPA activities for audit trail
and compliance purposes.
Emphasize Continuous
Improvement: Continuously seek
ways to enhance NCR and CAPA
processes to drive efficiency and
effectiveness in quality management.