1. NCR/CAPA
ASQ North Jersey Spring Quality
Conference, April 2nd, 2015
M MICHAEL KOCHIAN
BSI Client Manager, ER Lead Assessor
RAB/QSA ISO 9001 / ISO 13485 Lead Auditor
4. To present an overview of Control of
Nonconforming Product, and
Corrective Action and Preventive Action
PURPOSE
5. Intended Audience:
This presentation is planned with the
intention of providing valuable overview for
individuals who are new to the field of
Quality Assurance as well as those who have
been in the field for a number of years.
6. Quality Management System Overview
What is Quality & Quality Management according to International Organization for
Standardization (ISO)?
-Quality is defined as the “Degree to which a set of inherent characteristics fulfills
requirements.”
Clause 3.1.1 ISO 9000:2005 Standard
-Quality Management is defined as “coordinated activities to direct and control an
organization with regard to quality”.
Clause 3.2.3 ISO 9000:2005 Standard
The requirements of the ISO 9001 / ISO 13485 do not tell you “how to run your
business…That is up to you…The requirements describe “what” needs to be achieved.
7. What is Quality Management System?
-It is the organization structure, responsibilities, procedures and
resources for ensuring the quality of a product or service.
-To develop and implement an effective QMS we need to:
• Determine a means to prevent non-conformities.
• Evaluate processes for continual improvement of the system.
• We need have a corrective action and preventive action process in
place that documents problems or potential problems that may
affect customers.
9. How we define a Nonconforming product?
Nonconforming product is defined as product that does not
conform to customer requirements; applicable regulatory
requirements, or to your own organization requirements.
The definition may also apply to nonconforming processes and
services.
Nonconformities may relate to suppliers and outsourced work;
your own organizational activities or product shipped to
customer, and product returned from customer.
10. How does FDA define nonconformance?
a nonconformance is the failure to fulfill a specified
requirement.
Sounds simple enough, but in the FDA’s world, the phrase
“specified requirement” covers a multitude of expectations and
manufacturing levels, including requirements, specifications,
and process parameters that are stated – explicitly (directly) and
implicitly (indirectly) – by an organization, its customers, or
other interested parties.
11. ISO 13485 Standard (Clause 8.3) - requirements
describe “what” needs to be achieved for Control
of Nonconforming Product:
The organization shall ensure that product which does not
conform to product requirements is identified and controlled
to prevent its unintended use or delivery. The organization
shall document a procedure to define the controls and related
responsibilities and authorities for the identification,
documentation, segregation, evaluation, and disposition of
nonconforming product.
12. ISO 13485 Standard (Clause 8.3) -
requirements describe “what” needs to be
achieved for Evaluation:
The evaluation of nonconformity shall include a
determination of the need for an investigation and
notification of the persons or organizations responsible for
the nonconformity. Nonconforming product shall be
considered for an escalation to corrective action. The
evaluation and any investigation shall be documented.
13. ISO 13485 Standard (Clause 8.3) - requirements
describe “what” needs to be achieved before
deliver:
Action in response to nonconforming product before delivery
Where applicable, the organization shall deal with nonconforming product
by one or more of the following ways
a) By taking action to eliminate the detected nonconformance;
b) By taking action to preclude its original intended use or application;
The organization shall ensure that nonconforming product is acceptable
by concession only if appropriate regulatory requirements are met, and
documentation, justification, approval signatures are on record.
14. ISO 13485 Standard (Clause 8.3) - requirements
describe “what” needs to be achieved after
delivery:
Action in response to nonconforming product after delivery
When nonconforming product is detected after delivery or use has
started, the organization shall take action appropriate to control the
risk associated with the nonconformity.
The organization shall establish a documented procedure for the
issuance and implementation of Advisory Notices.
15. What are the basic steps? -
Non-Conforming Products shall be:
• Clearly identified using consistent identification (tagging)
• Contained through the use of a Containment Action
• Segregated in well identified areas
• Released using a defined process and authority
• Reintroduced into the process stream at or prior to the point of
removal
• Product containment issues could be reviewed by Leadership
16. Responsibilities of
Managers/Supervisors/Employees :
-Managers/Supervisors :
• To follow their internal procedural steps on Control of Nonconforming Product
• Conduct a preliminary evaluation of a reported product/service non-conformance,
• Ensure non-conforming product or service identified through inspection, audits
and/or customer complaint, and segregated, documented and tagged.
-Employees :
• To follow their internal procedural steps on Control of Nonconforming Product
• Identify, control and notify the Department Supervisor/Manager (or Delegate) of
any non-conforming material or service.
17. The MATERIAL REVIEW BOARD (MRB):
Most companies have a MRB that is responsible for making the decisions related to
disposition of nonconforming material. Typically, the MRB will be scheduled once
per week to review the most recent nonconformities. The board usually consists of
a cross-functional team, such as:
Quality Assurance & Regulatory Research & Development
Manufacturing & Engineering Supply Chain
The reason for a cross-functional team is to review potential adverse effects of
rework and potential risks associated with a UAI disposition. If rework is required,
the cross-functional team will typically have the necessary expertise to create a
rework instruction and to review and approve that rework instruction–including
any additional inspections that may be required beyond the standard inspection.
18. The following possible dispositions may be determined
by the Supervisors/Managers during MRB review:
• Scrap - A disposition of nonconforming material that is not usable for its intended
purpose and which cannot be economically reworked.
• Return To Vendor (RTV) - A disposition to return nonconforming purchased material
to the vendor (supplier). If the Nonconformance analysis of data shows upward
trend, than decide to initiate a SCAR.
• Rework (to Print)* - A planned manufacturing process that completely restores all
nonconforming characteristics to the requirements of the contract, specifications,
drawing or other approved product description.
• Accept As Is. (Also "Use As Is")* - A disposition of material with minor
nonconformance(s) determined to be usable for its intended purpose. “Concession
is required”*
19. Communication:
-When do you call the customer?
A potential external issue may exist when you are not confident all
product is contained as evidenced by:
• Investigation shows that the potential quality defects exceeds the
quality found.
• The oldest material in-house contains product which exhibits the non-
conformance.
• Contact customer internal/external as required to stop the spread of
problem “Containment Action”.
20. ISO 13485 Standard (Clause 8.3) - requirements
describe “what” needs to be achieved for
Rework (to Print) :
*Rework is a form of correction. If product needs to be reworked
(one or more times), the organization shall document the rework
process in a work instruction that has undergone the same
authorization and approval procedure as the original work
instruction. Prior to authorization and approval of the work
instruction, a determination of any adverse effect of the rework
upon product shall be made and documented (see 4.2.3 and
7.5.1).
21. ISO 13485 Standard (Clause 8.3) - requirements
describe “what” needs to be achieved for Accept As
Is. (Also "Use As Is") :
Permission to use or release a product that does not conform to specified
requirements.
NOTE: A concession is generally limited to the delivery of a product that has
nonconforming characteristics within specified limits for an agreed time or
quantity of that product.
Records shall be maintained of the identity of the person(s) authorizing the
concession, nature of nonconformities and any subsequent actions taken,
including rational for decision made and concessions obtained.
22. A concession always could be :
• Limited in time and quantity
• Carefully controlled
• Appropriately authorized
• Well documented, and
• Claimed after identifying the nonconformance
“
FDA Expectations for Medical Device concerning
“Concessions”
23. What are the benefits of using
Control of nonconforming product?
• It is a reactive action to disposition an identified nonconformance.
• Assures all product not confirming to specification requirements are:
• Prevented from unintended use to protect the next downstream customer
• Contained and/or segregated to protect the next downstream customer
• Dispositioned by Management to protect the next downstream customer
• Increases customer satisfaction and communication
• Reduces quality disruptions
• Assures all identified issues are resolved with all customer contacts:
• Internal and external
• Assures a “systematic approach” for all issues.
26. FDA 21 CFR 820 (I, J)
Require establishment and maintenance of
nonconformance and corrective and preventive action
(CAPA) procedures. Nonconformance's relating to product,
processes, and quality system should be investigated.
Actions needed to correct and prevent recurrence must be
identified. Corrective action has to be validated to ensure
effectiveness. All activities pertaining to nonconformance
and CAPA must be documented.
27. CAPA – Corrective and Preventive Action
Corrective Action and Preventive Action is a
nonconformance management program that
focuses on the systematic investigation of
discrepancies, adverse events, or failures.
28. The benefits of using CAPA :
If used properly, the Corrective Action and
Preventive Action (CAPA) system will provide
a means to prevent the nonconformance
from recurring.
29. The benefits of using CAPA :
• It provides a structured platform to conduct a systematic
investigation of the nonconference.
• The investigation provides the means to develop a
permanent corrective action.
• It provides a frame work for documentation that the
implemented corrective actions are indeed effective.
30. The benefits of using CAPA :
Additionally, a CAPA system is the cornerstone of the organization’s
Quality Management System (QMS).
Corrective Action taken could help to eliminate the root cause and
symptom of an existing nonconformity to prevent from recurrence.
This is a REACTIVE action that eliminates problems identified in
products, services, or processes and takes care of the immediate
problem.
31. PREVENTIV ACTION
This is an action taken to eliminate the potential causes of a
nonconformity, defect, or other undesirable situation in order to prevent
occurrence.
Proactive action which avoids nonconformance's through planned
activities.
32. CAPA System :
There are Seven Steps to CAPA Process:
1. Discovery of the Nonconformance
2. Documentation of the Nonconformance's
3. Immediate Corrective Action “Containment Action”
4. Investigation of the Root Cause
5. Causal Analysis : “Risk Assessment”
6. Corrective Action
7. Effectiveness Evaluation
33. What activities will help you to identify
potential Nonconformance’s :
Means by performing:
• External Audits
• Internal Audits
• Staff Observations
• Performing a task
• Inspection and Testing
• Process and Equipment
Monitoring
• Record Review
• Change Control
• Material Review Boards
• Complaints
• Adverse Events
• Product Returns or Recalls
• Notifications by a customer or a client
34. Nonconformance once they have been
identified shall be Documented:
The objective is to create a document that is an accurate, complete
description of the event so that anyone can understand it.
• External Auditors : identify and document nonconformance's
• Internal Auditors : identify and document nonconformance's
• Technical Staff : identify and document nonconformance's
• Administrative Staff : identify and document nonconformance's
Essentially, the document could contain all the details, without the use
of jargon. To create a well documented and effective narrative based
on what is been observed or explained.
35. Rules on Documentation :
• If it isn’t documented, it didn’t happen
• If it isn’t documented, it doesn’t exist
Questions to consider: In documenting an accurate description of the
nonconformance, include following details.
• What was discovered?
• Who was involved?
• When did the nonconformance discovered?
• How was the nonconformance discovered?
• How frequently does the process occur?
36. First Step In CAPA: Immediate Corrective Action
“Containment”:
An Immediate Corrective Action “containment” is essentially
a description of the steps taken to gain control of a situation
or product immediately following the discovery of a
nonconformance.
The immediate corrective action keeps the nonconformance’s
scope from expanding. It also quickly resolves or corrects a
discovered event, problem, or situation until the root cause is
determined.
37. Examples of Immediate Corrections/Containment
Action Steps:
Products:
• Quarantined
• Isolated
• Discarded
• Communicated to stop the
spread of problem
Equipment:
• Remove from Service
• Replace
Process:
• Manufacturing Suspended
• Test Results Withheld
• Recovery Procedure Halted
“Software”, “Repair”, “Machine”
38. Investigation Objectives :
A through investigation will provide the needed information to
establish the root cause.
• Understanding of how or why the nonconformance occurred.
• Understanding of the circumstances at the time of the
nonconformance.
• Determination of other products, processes, or individuals
were involved.
• Gathering of data to aid in the accurate future determination
of a root cause and development of corrective action.
39. Know barriers :
• The problem is poorly or incorrectly defined.
• A systematic approach is not used.
• Investigations are stopped prematurely.
• Decisions are based on guesses, hunches or assumptions.
• An inadequate level of detail is employed.
• Interim containment fixes are sometimes allowed to become
"permanent."
• The skills, knowledge and experience needed to uncover the root cause
are not available.
• A lack of organizational will to tackle the "bigger" issues.
• Fear of being blamed.
• "I don't have the time."
40. Second Step in CAPA: Root Cause Analysis
Principle
Data Collection
• Interview : Staff, Customers, Supplier
• Review : Policies, Procedures, Forms
• Record Review : Training, Production, Equipment, Methods, Material,
Process Flow, Batch Records, ECN
Cause Analysis :
• WHY did it happen?
• What factors contributed?
• Were there known any barriers present?
• How could it have been prevented?
41. Root Cause Analysis Principle :
• Discover the primary (root) cause.
• Maintain quality and compliance.
• The Root Cause Analysis must be the result of a systematic
process which contains well documented evidence.
• Any given problem will have more than one root cause.
• To be effective, the Root Cause Analysis must establish all
known causes and the defined problem.
• Performance improvement measures directed at root cause
are more effective than treating the symptoms of a problem.
42. No formula for finding root causes exists
Start by studying symptoms
Group causes into like categories
44. Are the causes interrelated?
When the root cause is found, always ask the "root cause
question:
"Does this cause (or causes) explain all that we know about
what the problem is, as well as all we know about what the
problem isn't?"
45. Pick A Systematic Technique :
Consistent application of one or more of these problem solving tools
along with the questions mentioned will provide a good platform to
arrive at an accurate determination of root cause or causes.
• 5 Whys
• Cause and Effect Diagram – “Fishbone”
• Tree Diagram
• Scatter Diagram
• Statistical Process Control
46. Document Corrective Action Objective :
To generate a plan of action that will eliminate or reduce the incidence of
the root cause of the nonconformance, failure, or breakdown.
Development of Corrective Action:
• Decide the mean to implement the action:
• SOPs may need to be established or revised
• Process Changes may need to be introduced through “ECN”
• Training or Retraining may need to identified and completed
• Implementation of automation or new equipment “ECN”
• Decide on the implementation timeframe
• Determine the method of CA communication
• Determine staff involvement in carrying out the CA
47. Corrective Action Considerations :
• Do not expand the corrective action beyond the identified
root cause.
• The corrective action must match the root cause of the
nonconformance.
• If possible, build the corrective action upon existing or
know barriers.
• Remember that continuous correction is not quality
improvement.
48. What needs to be documented for Effectiveness
Evaluation to be complete :
The objective of the Effectiveness Evaluation is to generate
documentation that proves or disproves the following two
statements:
• The Corrective Action was completed and implemented as
planned.
• The Corrective Action was effective in the reduction or halt
of recurring nonconformance's.
49. Effectiveness Evaluation Steps :
• Who carries these steps out?
• Reporting of the Effectiveness Evaluation with documented
evidences.
• Verify that Corrective Action was properly implemented.
• Determine data source for Effectiveness Evaluation.
• Determine when to perform Effectiveness Evaluation.
• Determine evaluation period.
• Consider impact of learning curve.
• Determine success criteria.
50. Effectiveness Check - Timeframe for Evaluation :
In most cases, the evaluation could be started no earlier than 30 days.
This ensures that the staff is competent and familiar with the corrective
action submitted.
Depending on the organizational SOP, the evaluation for effectiveness
could begin with 60 days of the Corrective Action plan implementation
date.
Depending on the organizations SOP, the evaluation could be completed
no later than 120 days after Corrective Action implementation.
51. Effectiveness Measurement :
Observe staff directly involved in the execution of the Corrective Action
alongside a small sample of other staff members (one to five) not
directly involved in the corrective action.
Review source documents involved in the Corrective Action for one to
three months post implementation. Look for omissions, corrections, or
completion attributes that reflect a recurrence of the original deviation.
For each Effectiveness Evaluation performed, a memo could be
generated to document and summarize what was done for the
evaluation and the resultant outcome.
52. When Effectiveness Evaluation Shows Failure:
• Issue a new nonconformity.
• The Root Cause Analysis will need to be redone.
Items to consider:
• There may have been multiple root causes that were not initially
discovered.
• There may have been significant contributing factors that were not
discovered.
