PPT. on Nonconformance

1. Presented by : Presented to :
Shreyansh Singh Dr. Pragya
Mishra
M.Voc (3rd semester) (Asst. Prof.)

2.  Definition
 Examples
 Types of non-conformities
 Management process
 Role of QMS in noncnformance
 Final thoughts

3.  Nonconformance is defined as the
event in which a product, service,
or process does not meet the
establish requirements.
or
 Non- conformance or non-
conformity is the failure to meet
specified requirements. Non-
conformity can occur on both the
process and the product.

4.  ISO 9001: 2015
A non-conformance is the non-
fulfillment of a requirement. This can
encompass various issues, such as
departures from established
procedures, failure to meet customer
expectations, or noncompliance with
regulatory requirements.
 FDA 21 CFR Part 820
It indicates occurrences where a
medical device manufacturer fails to
meet specific requirements established
under the regulation.
These requirements include design
control, manufacturing processes,
documentation, quality system
procedures, and more.

5. 1. Minor non-conformance
 A single missing or unsigned document.
 Any unauthorized alteration to a document.
 Release a purchase order without prior approval.
 Using an instrument after its calibration date.
 Customer complaint that is not resolved in a timely
manner.

6. 2. Major non-conformance
 Multiple missing or unsigned documents.
 Problems that adversely affect processes or
operations.
 Distributing a product that is unsafe to use.
 A serious safety hazard in the workplace.
 Contamination of a product with foreign
materials.

8.  Identify the
nonconformance by
monitoring key
performance indicators
(KPIs), customer feedback,
inspections, audits, or
other monitoring
mechanisms to promptly
detect any issues that may
arise.

9.  Create a formal nonconformance
report (NCR) that documents all
the essential details about the
identified issue, including its
nature, location, date, personnel
involved, affected products or
processes, and any immediate
actions taken.
 The nonconformance report
serves as an official record that
provides a clear and
comprehensive account of the
nonconformance.

10.  Conduct a thorough analysis
to determine the root cause of
the nonconformance using
tools such as 5 Whys,
Fishbone Diagrams, FMEA,
or Root Cause Analysis.

11.  Corrective actions are measures
taken to address and solve existing
nonconformances. Preventive
actions involve proactively
identifying and implementing
measures to prevent potential
similar events from occurring in the
f.uture

12.  QMS software automates and
streamlines the nonconformance
management process, making it
more efficient and effective.
 Automated reminders, notifications,
and pre-defined workflows can
accelerate the nonconformance
resolution process, while robust
reporting tools enable better
monitoring.

13.  Nonconformances are any issues or divergences that occur
when a process or product does not meet its established
requirements.
 Nowadays, electronic QMS are substituting paper-based and
hybrid systems for managing nonconformances as they offer
several benefits. QMS software streamlines the handling of
nonconformances, ultimately improving both quality and
compliance efforts.
 The Simpler QMS software is designed specifically for the
needs of companies, offering quality and nonconformance
management capabilities. By providing interconnected
processes and pre-defined workflows, users are guided
through the stages of each process, helping ensure compliance
with requirements.