FDA Failure Analysis Template customer city skylines, this one is Boston USA.

Introduction to FDA Failure Analysis

This schematic indicates FDA Failure Analysis types.

Failure Mode Effects & Analysis.

The early use of a FDA Failure Analysis template document for quality and risk assessment can very often preclude problems arising later in the design or build stages of any project. Clients rely on their service providers to use methods and or tools that can reliably give a high degree of confidence that as far as is practically possible, analysis processes have been used that will ensure all such aberrations are anticipated and catered for. The challenge is to design in; quality and reliability at the beginning of the process and ensure that unplanned defects never arise.

Validation Online has simplified the task of developing and using a Failure Mode Evaluation & Analysis as a method of analyzing risk by sequencing and detailing each stage in the generation and use of all the associated charts and assessment lists. The Risk Assessment Tables (Severity / Ocurance / Detection) are included and referenced ready for use. An analysis flow chart is included to ensure that the overall process is displayed pictorially and hence is easy to follow and the actual failure analysis spread sheet is capable o0f being expanded to what ever size is required. All complexity has been removed and the this analysis tool can be used by first timers or experts with equal ease.

Try it, and find out just how good an Failure Mode And Effects Analysis can be at assisting you to anticipate problems and then preempt them through Risk Mitigation. This document is fully detailed and unconditionally guaranteed to be fit for purpose. Once you start using this method of measuring risk, you really will wonder how you managed before. Regulatory agencies world wide now require documented evidence that processes and techniques have been subjected some form of risk analysis.


Failure Mode and Effects Analysis is a model used to identify and prioritize potential defects based on their severity, expected frequency, and likelihood of detection. A Failure Mode And Effects Analysis can be performed on a design, an intended design, an individual process or a complete production process.  It is used to prompt actions to improve design or process robustness. The analysis highlights weaknesses in the current design or process in terms of the customer, and is an excellent vehicle to prioritize and organize continuous improvement efforts on areas which offer the greatest return.  The VRA should be used to set the scope in validation of the Installation Qualification (IQ), the Operational Qualification, the Performace Qualification (P1Q) and the Process Qualification (P2Q).

The use of the Failure Mode And Effects Analysis.

System FDA Failure Analysis Template's:

A system or subsystem is a collection of elements or components working together to accomplish a desired function. Failure Mode And Effects Analysis is often applied at system or subsystem level to identify potential modes and effects that could negatively impact on the system or subsystem performance.

Design FDA Failure Analysis (FMEA) Template:

A product design is a set of specifications that describes all aspects of product i.e. major functions, operating parameters, tolerances, materials, dimensions etc. FDA Failure Analysis SOP Templates (FMEA) are applied to product potential and actual designs as early in the in the product development process as possible.


A process design is a set of specifications that describes all aspects of a process i.e. functions, component parts, flow rates, process steps, equipment, test equipment, operator skills, etc. Process design FME analysis is also applied at the earliest possible stage in the process development with the intent of highlighting potential process failures or design flaws.

The FDA Failure Analysis SOP (FMEA) Template is simply excellent for bio-med processes, since it demands that every aspect of the process is reviewed; while accepting and anticipating the fact that things do go wrong. Once this concept is accepted you can probe further by inquiring, what goes wrong, how often does it go wrong and can we preempt it going wrong? Further to this we can then analysis; whether a failure will be detrimental to product quality. This knowledge can then be use to devise methods for protecting the product.

If a failure does not readily manifest itself, do we really have to let it destroy the product, or can we build in product protection? The execution of a FDA Failure Analysis using an FMEA provokes thought about these things and stimulates activities that can and do lead to much more robust processes.

Percent Reduction in RPN

When the RPN aggregate is found to be excessively high, then there is a justification to proceed in investigating methods of reducing the risks to lower levels. In some cases, it may be appropriate to revise the initial risk assessment based on the assumption (or the fact) that the recommended actions have already been incorporated. This provides an indication of the effectiveness of corrective actions and can also be used to evaluate the value to the organization of performing a Failure Mode and Effect Analysis.  To calculate revised RPNs, the analysis team assigns a second set of Severity, Occurrence and Detection ratings for each issue (using the same rating scales) and multiplies the revised ratings to calculate the revised RPNs. If both initial and revised RPNs have been assigned, the percentage reduction in RPN can also be calculated.

Risk Assessed















Percentage Reduction in REN


VRA or FDA Failure Analysis.

Risk Assessment (RA) in the pharmaceutical / biotech / medical device industry, is often misunderstood.  In the industry in general RA’s are used at various stages in the product development, production and in testing.  Practically always to assure that the product or equipment is robust and fit for purpose. 

Generally in these tasks there are many ways of mitigating risk.  Whether it is by adjust design parameters, introducing controls or retraining staff, sometimes the choice is endless.

In validation this range of solutions are not there.  There are regulatory requirements about documenting justifications, and requirements for critical and none critical software; but not a lot more.

So it actually makes sense to appraise this task in a reverse order; and start with what degree of validation can we define with reasonable accuracy.  It becomes apparently that we have not got an infinite variety.  Certainly not one we could easily define.  So what do we have?

No Validation

Simple validation,

Basic Validation (Registration)

Standard Validation.

Full Life Cycle Validation.

If we use the likes of an Failure Mode & Effect Analysis we will have a cumbersome analysis result that becomes difficult to use to attribute the correct degree of validation.  If we develop a Validation Risk Assessment that only has four outcomes; we can match these outcomes to the four requirements detailed above.

This is the method Validation Online has adopted and used for many years now.  The regulators want to see a documented justification for the scope of validation that you have applied, and they require a documented judgement about 21 CFR Part 11, applicability.  These requirements are satisfied in our Validation Risk Assessment, where the risk being mitigated is the risk of not being compliant with the regulatory requirements.

FDA Failure Analysis.

Validation Master Plan (Issue 8) -- $115.00

The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable cGMP requirements as specified in 21 CFR Part 11, 210, 211 and 820 into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks.  It must mandate the production of all Practices and Procedure manuals and SOP's.


Validation Plan (Issue 10) -- $93.00

The VP must document all methodologies, boundaries and responsibilities, along with defining validation limitation and scopes.  It is a master reference for all validation variables and queries.


Validation Risk Assessment (Issue11.) -- $125.00

When you declare that your validation is Risk based; then it is incumbent on you to use a suitable tool to convert the perceived level of risk to an appropriate intensity of validation.  This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.  This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance rulings.


 Package for Equipment Validation Level-2. (Issue 3) -- $585.00

During a regulatory visit the inspectors do expect to see a complete suite of validation documents in place for each validation task.  The use and scope of the individual documents has been documented, discussed and explained in detail.  It is therefore obviously best policy to have in place exactly what the regulator is looking for.  The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated