Non-Conformance Report is a document,in short NCR,outlines the details of the product failure in meeting the standards.

1. Step-by-Step instructions to write a Non-Conformance
Report
Article Context:
o Non Conformance Report
o Step-by-step instructions to write an effective Non-Conformance
Report
The different processes involving multiple roles like supplier, production,
manufacturer, and pieces of equipment for designing or marketing a
product will inevitably invite some non-conformance within the
organization. A non-conformance occurs when a product or service, or
process deviates from the industry specifications. Therefore, it is not
surprising that product delivery is crucial when satisfying customer
expectations, market trends, management profits, and compliance.
With regular Non-Conformances (NC), the organization’s efficiency,
product-process effectiveness, brand reputation, and company finances are
questionable as customers’ health and safety can be adversely affected. So,
when a non-conformance occurs, rather than seeing it as an issue, see it as
an opportunity to fuel the continuous improvement of the

2. product/processes using the findings. The key to opportunity lies in how
well the investigation findings are documented and how well the non-
conformance report is constructed.
In this article, let us learn step-by-step instructions for writing an effective
non-conformance report and its importance.
Non-Conformance Report
Non-Conformance Report is a document, in short NCR, outlines the details
of the product failure in meeting the standards. The record holds
information like how a non-conformance occurred, the investigation-
analysis information, and how to deal with the non-conformance before
determining the corrective action plan.
It is essential to know that the Non-conformance report is to deal with the
defects and correct the failure, if needed, to eliminate the cause of failure. It
is not just to comply with the standards and regulations of the FDA (Food
and Drug Administration), ISO (International Standards Organization).
The Non-Conformance report must be complied with by the quality
management team, the quality manager, or the head of quality, or other
relevant positions of the quality management team.
Step-by-step instructions to write an effective Non-
Conformance Report (NCR)
To write an effective Non-Conformance Report, follow the below-listed
steps.
Identify and Control the Non-Conformance
The NCR starts with the identification of a product or process failure.
A NC can occur at any stage in the manufacturing or production, or
operation process. When identified, the description of the event should be
made clear as it is the base for the investigation process. At times, the Non-

3. conformance identification could be challenging as it leads to product
recalls or CAPA (Corrective and Preventive Action), where
more resources and costs are involved with the former. And,
with CAPA, the complete process gets shut down
until implementing corrective actions and preventive actions.
With the identification of non-conformance, controlling action is prescribed
by the Quality Control Board to hold the non-conformance issue
on the floor to properly access the non-conformance management process
to take the appropriate action.
Non-Conformance Review
The life science industries handle this step by summoning a stand-
by Material Review Board (MRB). The MRB is responsible for reviewing the
non-conformance event and determining the actionable steps. The review
process involves the controlling and segregation of non-conformance
and addressing the violated requirement or specification.
Determine the action plan
With the reviewal of the source and occurrence details of non-
conformance, this step determines the correct actions to dispose of the
non-conformances. Disposition is an action plan that defines the corrective
measures laid for resolving the non-conformances.
According to FDA, the organizations have the flexibility to decide the
necessity of the investigation process for non-conformance. Additionally,
dispositions can cover corrections or can be no actions at times. If the non-
conformance is a defect identified for the first time, then the organizations
should call for an investigation process; if it is due to the previous process
failure, then organizations may not require initiating an additional
investigation process.

4. Listed are the five disposition categories, and the non-
conformances fall into one of the following:
o Rework – When a product or process fails to meet the
specification, the disposition takes a minor
correction action and allows the product or process to meet the
specifications.
o Recall – Call off the process or product, i.e., Destroy the product
or method instead of using it.
o Return to Supplier – When the supplier ships the wrong or defective
pieces of product, they must be returned.
o Use as is – When a product is found defective, but that doesn’t cause
harm to the end-users, and that is determined to use as intended.
o Downgrade – When the need for an updated version for resolving a
product defect but the previous version is in use until the resolution.
Any minimal action or no action after identifying Non-conformance should
be tracked and recorded for inspections and audits.
Analyze the Root Cause
Analyzing the root cause of the problem is the only way to determine the
necessity of an investigation process. The organizations should look for
the probable causes for the occurrence of non-conformance, and finding
the actual cause is the most challenging. The aim is to reach
the cause that triggered its events.
This step in a Non-Conformance Report is essential. Document all your
findings and investigative information of the actual and potential
causes and their impact with the required objective evidence.
After assembling the required data, involve the expert team to determine
the factors that caused the non-conformance by using the root cause
methodologies like 5 Why’s, Ishikawa Diagram, Fault tree analysis, or
FEMA. Using one or more methods, you will achieve the potential cause. Be
persistent and keep tracking the findings and documenting them.

5. The iQuality’s Quality Management Software enables an easy and
streamlined process to get to the insights of your quality, data, saving
time and resources while improving the quality of work.
Verify the closure
Concerning the root cause, if the non-conformance is minor, then with
minimal actions, NC can be closed and verified. Such as: Implementing
training for the employees, clear and defined work instructions, change in
the process cycle, refraining the product acceptability, etc.
What if the non-conformance is of major type? which impacts the multiple
processes and can cause a systematic issue down the line leading to the
requirement of Corrective and Preventive actions as Non-
Conformances is the front-end mechanism for CAPA. Any activity in
suggestion where the problem recurs will initiate a CAPA.
Initiate a CAPA when the problem is systematic, critical, complex, and
impacts multiple processes as it creates burdensome work and negatively
impacts the reputation and profits of the company.
Monitor Effectiveness
After determining the corrections for non-conformances, this step may
seem less critical. But monitoring the identified processes and products to
ensure the problem does not recur is vital for a closer inspection of Non-
Conformance Management. With that, the steps determined for problem
elimination and the root cause analysis are proved accurate. If it
recurs, move back to step three, drill down to the actionable
plan, and check for additional issues.
Documentation
Documentation is vital in Non-Conformance Report. Therefore, every step
of the process should include the documentation elaborating the process’s

6. relevant findings and actionable plans. In addition, ensure documentation
has complete reviewal and approval actions finalizing the non-
conformance closure.
Non-Conformance Report Management Best Practices
Writing a Non-Conformance Report is an opportunity to leverage
the essential findings and improvements. So to write an effective Non-
Conformance Report, follow the listed best practices.
o Documentation – Document the non-conformance from identification
to closure, describing the events and analysis performed with
approvals and required signatures.
o Categorization – Identify and segregate the Non-Conformances into
minor and major, ensuring the required corrections are in place.
o Ownership – Determine the owners of the Non-
Conformances and review the open, in-progress, and closed NC’s
periodically updating them in the documentation.
o Tracking – Track the NC’s sources and causes in line with the
processes noticing the systematic issues and escalating CAPA.
o SOP (Standard Operating Procedures) – Provide SOP for the
employees to follow.
o Review – Regularly review the process followed as your organization
scale.
Leverage Quality Management Software to manage Non-
Conformances, ensuring compliance
The non-conformances identified are the result of a reactive and
defensive action of a process or service followed by the
organization. Therefore, a proactive and preventive approach process is
required to resolve. But the methods identified by the quality heads often
hamper the process ending up in a deviation. As the organizations depend
on a paper-based process for managing non-conformances and quality
integration with departments or different sections
is tedious. The restrictions in storage and access are often violated with
no proof of changes made or by whom. For effective quality delivery

7. ensuring customer satisfaction requires well-established systematic
processes and procedures. Additionally, to focus on meeting the standards
of regulations, production, and management profits, an intelligent QMS is
needed.
iQuality QMS (iQMS) ensures non-conformances management leveraging
quality policy, quality risk management, and quality
objectives in compliance.
With iQMS,
o Organizations can be sure of seamless inter-
department collaboration facilitating non-conformances
management.
o A centralized system allows real-time management of recorded
data with insights of similar patterns to get to the root cause of the
issue faster and efficiently.
o The data retrieval process is fast and easy as when needed for
effective audits and inspections.
o E-Signatures in compliant with 21 CFR (Code of Federal
Regulations) Part 11
o With integrated AI (Artificial Intelligence) and ML (Machine
Learning) algorithm capabilities, get predictive
analysis and dynamic insights into the organization’s critical gaps.
Would like to learn more about non-conformance management and how to
write NCR? We are just an email away from sales@complianceg.com.