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 FMEA 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.

Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’. It has been carefully designed to make it the preferred choice for Process and Laboratory stand alone equipment and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 

User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.

Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.

Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.

Combined IQ/OQ/PQ for Spreadsheets. (issue-2) $159.00

This combination protocol has been specifically designed to verify that all aspects of your spreadsheet conform to best practice and that the spreadsheet layout ensures consistent and accurate use and results. The tests and inspections normally authored in separate protocols have been assembled in one protocol which is divided into three sections. This protocol enables you to verify that your developed spreadsheet application is GMP compliant, thus avoiding 483s and warning letters. You can now validate your application with minimal documentation. Equipment Validation Protocol, validation protocol template.

Design Qualification (Issue 5) -- $115.00

The Standard Operating Procedure attached to this generic design Performance qualification Template, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained

Issue - 4. 

This Validation Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format.  Resulting in the document becoming notably easier to use and quicker to review and amend.  This new format will make a very significant difference to the man hours required to produce and execute these documents.  There will also be a very noticeable reduction in the time required for the reviewing and approving tasks.  This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. 

Issue - 4. 

4Q Equipment Validation4u Protocol (4Q-Equip) has been designed specifically to replace four standard protocols.   By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation4u  documentation by reducing protocol numbers by close to 75%.  The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & Performance qualification template P1Q) and now compliments our equally new VrrP Protocol.  By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, it is still written in word and compliant with FDA GMP Part 11 legislation.

Combined IQ-OQ-PQ Equipment. (Issue-8)  $159.00

This quite unique two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated.
Both documents are prefaced with a methods' Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique but also highly cost-effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics and are compliant with FDA GMP Part 11 regulations.