Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959
 info@antrix.com

Nonconforming Material Report (NCMR), Deviations and Corrective Action, Preventive Action (CAPA)

1. Service Description

Corrective Action Preventive Action (CAPA), Deviations, and Nonconformances (NCMR).

There will be productivity increase and cost savings of more than 80% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.


2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 80 % > 80 % > 80 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.

 


CAPA

CAPA stands for Corrective Action and Preventive Action

The service will customize the process of initiating, processing and documenting a CAPA in order to ensure that causes of nonconformities or undesirable situations are investigated and appropriate corrective actions are implemented to prevent recurrence.

When would you perform Corrective Action, Preventive Action?

You would perform corrective action and/or preventive action when there are systemic problem in either product, process, documentation or any other issue identified in an organization.

1. Solution Approach

We will document the complete workflow from submission, approval, assigned corrections, resolution, verification and closure of CAPA and implement it in the system of your choice.

Figure 3 - Corrective Action and Preventive Action Management System Workflow

CAPA Process Flow

Figure 4 - CAPA Process Flow - Source IBM

2. Definitions

Corrective Action: Action(s) taken to identify and contain an issue or to eliminate or correct the cause of a detected nonconformance or other undesirable situation. A corrective action is taken to prevent recurrence of a nonconformance

Preventive Action: Action(s) taken to eliminate the cause of a potential nonconformance or other undesirable situation. Preventive action is taken to prevent occurrence of a nonconformance.

Nonconformity: Non-fulfillment of a requirement of quality, (e.g., failure of system, component, subassembly or material,).

Correction: Action taken to eliminate an existing nonconformity that can be effectively resolved at a departmental or site-specific process level, (e.g. rework, adjustment, training, procedural change, or self-assessments).

Root Cause: The most fundamental reason for an action or condition that must be corrected to prevent recurrence of the same or similar nonconformity

Examples

  1. Equipment – e.g. – failure of system, component, subassembly or material

  2. Product e.g. systematic customer complaints, specifications, intended use, safety etc.

  3. Process – e.g. – process failures (out of specification)

  4. Other – e.g. – Documentation

3. Applicable Laws, Regulations and Standards

  1. QSR – 21 CFR Part 820.100

  2. ISO – 13485:2003 – Section 8.5.2 and 8.5.3

 

NCMR

This service will define the process of initiating, processing, controlling and documenting a nonconforming material or product to prevent its unintended use or delivery.

What is nonconforming material?

It is material or product, which has failed to meet it's acceptance criteria or specification. The purpose of the nonconforming material process is to ensure that this material is not inadvertently used or released for use without further evaluation. Therefore the process has controls to ensure that the material is identified and segregated, and that there is a documented evaluation and final disposition of the material by an authorized group, which is commonly referred to as the MRB (Material Review Board).

1. Solution Approach

We will document the complete workflow from NCMR Submission, Assignment, Resolution, Verification, MRB Approval, and Material Disposition to closure.

Figure 1 - Example Nonconformance Management System Workflow

2. Definitions

Nonconforming: Non-fulfillment of a specified requirement.

Nonconforming Material Report (NCMR): A report that serves as primary documentation of nonconformance and the actions associated with it.

Corrective Action:  Action to eliminate the cause of a detected nonconformity or other undesirable potential situation.

Correction:  Action to eliminate a detected nonconformity (can be make in conjunction with a corrective action).

Material Review Board (MRB): A cross-functional team that reviews and approves actions associated with nonconforming material

Examples

  1. Materials – e.g. Improper packing, Storage, Leaking, Spec Failure

  2. Instruments – e.g. incorrect component, Labels Illegible, Missing

  3. Reagents e.g. Expired, Spec Failures

  4. Software – e.g. incorrect version

  5. Other – e.g. any other product

3. Applicable Laws, Regulations and Standards

  1. QSR – 21 CFR Part 820.90

  2. ISO – 13485:2003 – Section 8.3


Deviations

The service will describe the process of initiating and documenting planned and unplanned deviations during any product manufacturing, packaging, release or distribution process.

When do you use a deviation?

A deviation is used to document any time there is a variation from the approved procedure, process, testing or equipment. It is a temporary change or modification, which can be planned (i.e. part of a validation or new product development) or unplanned (i.e. problems with equipment). When product is manufactured or tested under a deviation, either a copy of the deviation or a reference to the deviation number should be included in the Device History Record (or batch record).

1. Solution Approach

We will document the complete workflow from submission, assign approvers, approval, assigned corrections, resolution, and closure of deviation and implement it in the system of your choice.

Figure 2 - Example Deviation Management System Workflow

2. Definitions

Deviation: departure from the originally specified requirements during product manufacturing, packaging, release or distribution process. It is only issued for a limited quantity of product or period of time and for a specific use.

Planned Deviation: Document that describes a departure from current procedures or process where approval is obtained before the event occurs. Expires in 90 days and 1 possible extension of 60 days.

Unplanned Deviation: Document that describes an departure from current approved procedures or process when there is insufficient time to obtain approval. (e.g. evening shift, middle of production run that cannot be stopped). Expires in 60 days with no extensions.

Examples

  1. Equipment - Departure from approved hardware, firmware or tools for manufacturing or testing processes

  2. Product - Departure from the current approved: Label, manuals, specification sheets etc. Use of materials specified in procedures and/or product specifications

  3. Process - Departure from the current approved procedures, test methods and processes is considered a deviation.

  4. Other  - Departure that is not captured by the preceding categories

3. Applicable Laws, Regulations and Standards

  1. QSR – 21 CFR Part 820.90

  2. ISO – 13485:2003 – Section 8.3