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FMEA FOR BIO-MED USE.

FMEA customer city skylines, this one is Boston USA.

Introducing the new FMEA for Bo-Med processes.....................CLICK HERE FOR DETAILS ON AUTOCLAVE VALIDATION......or..... CLICK HERE FOR BESPOKE READY TO USE VALIDATION PROTOCOLS.................CLICK HERE TO VIEW OUR SITE STATISTICS...............

INTRODUCTION & USE OF FMEA

This schematic indicates FMEA types.

Validation Online has taken the difficulty out of using a Fault Mode Evaluation & Analysis (FMEA) as a method of analysing risk.   All the risk assessment tables are included and referenced resdy for use. An analysis flow chart is included to ensure that the overall process is easy to follow and the actual fault analysis spread sheet is expandable 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 FMEA can be at assisting you to anticipate problems and then pre-empt them through risk mitigation .  This document carries our usual warranty; so if you find it unfit for purpose, your purchase costs will be refunded in full.

 

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. An FMEA 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 FMEA 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 (OQ), the Performace Qualification (P1Q) and the Process Qualification (P2Q).

This schematic depicts a FMEA flow chart that would be used to scope a Failure Mode Effect and Analysis document..

The FMEA document 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 enquiring, what goes wrong, how often does it go wrong and can we pre-empt it going wrong?  Further to this we can then analysis; whether a fault will be detrimental to product quality.  This knowledge can then be use to devise methods for protecting the product. 

 

If a fault 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 an FMEA provokes thought about these things and stimulates activities that can and do lead to much more robust processes.    

 

Percent Reduction in RPN

The very point of using the FMEA analysis is that on completion of the initial assessment, if the risks are found to be excessive, then there is a bases to proceed in investigating methods of reducing the these risks to acceptable 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 been completed. This provides an indication of the effectiveness of corrective actions and can also be used to evaluate the value to the organization of performing the FMEA. 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 percent reduction in RPN can also be calculated.

 

If the initial ratings (1) for a potential problem are S = 7, O = 8 and D = 5 and the ratings post any mitigating actions are S = 7, O = 6 and D = 4, then the percent reduction in RPN from the original to the revised is (280-168)/280) ×  100, or 40%. This indicates that the organization was able to reduce the risk associated with the issue by 40% through the performance of the FMEA and the implementation of corrective or mitigating actions. 

 

Risk Assessed

Severity

Occurrence

Detection

RPN

Initial

7

8

5

280

Reworked

7

6

4

168

Percentage Reduction in REN

40%

VRA or FMEA?

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, basically registering the equipment.

Standard Validation.

Full Life Cycle Validation.

If we use the likes of an Faulure 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.

 

FMEA


CLICK HERE FOR FURTHER DETAILS OF DOCUMENTATION AVAILABLE
Copyright © 2005

Validation Master Plan (Issue 7) -- $115.00

This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. This document interfaces with our Validation Risk Assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

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Validation Documentation Matrix (Issue 6.) -- $29.00

This Matrix must sit along-side your VMP or PVP and together with these documents give a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven separate headings, these may be edited as required (but come with all the standard documentation titles inserted). In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you an instant cross reference to the current documents.  The A to D prefix shows the progress stage.

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Combined IQ/OQ/PQ Protocol (Issue-2) -- $159.00

This 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. It is interactive, easy to use and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.

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Vendor Audit Document (Issue 4) -- $89.00

This document should be customised using the find and replace word feature. The document can then be re-focussed to reflect your project priorities. The fifteen chapters all contain 10 questions, the total scored is then weighted to reflect your priorities. By assessing the importance of each of the chapter subjects in your project, the weighting is altered taking points from one and adding to others. For example in a recent audit, after weighting, order of priorities became; delivery number one, validation number two, and price trailing at number nine. The document has been used to audit major and minor manufacturing and support companies. It is a very searching audit tool, and completely removes the possibility of suggestions that personal biases and opinions influenced the final audit decision. When you audit with this document; they know they have been audited.

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Validation Plan (Issue 8) -- $89.00

This document follows our well-developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.

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User Requirements Specification (Issue 7.) -- $115.00

The document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected, it will deliver the functions you want, it will have maintenance standards, it will have calibration records, it will have all the documents and records to enable successful validation to be completed. 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 URS through to the final PQ and OQ functionality testing.  This is a mandatory requirement for Full Life Cycle Validation (FLCV) of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or managed systems.

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Design Qualification (Issue 4.) -- $115.00

The Standard Operating Procedure attached to this generic design qualification protocol, 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.

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Validation Risk Assessment (Issue11.) -- $125.00

The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. 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 categorising and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).

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

The SOP used to generate this 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. There is now no reason for not being able to produce 4 to 8, IQ protocols per 8 hour day.


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Combined IQ-OQ (Issue-2) -- $125.00

This protocol is targeted at equipment and is suitable for all equipment from the laboratory to the process line.  All standard verifications are already included in the protocol format with many more test-scripts that can be edited in or out to tailor your IQ/OQ protocol exactly to your regulatory requirements.  Validation Online’s format of fully referenced, highly detailed interactive regulatory compliant documents has been extensively used by our customers in meeting their regulatory compliance needs throughout the world for ten years now.  Now this new combined IQ – OQ protocol brings a refreshingly simple and attractive approach for the industry professional to raise professional quality validation protocols in a most cost effective way.

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

You will find the step by step attached SOP 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 Operational Qualification Protocol. 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.

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Performance Qualification (P1Q) (Issue 5.) -- $89.00

The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it sometimes is the fact that the product is a very expensive product, and cannot be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.

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Process Qualification (P2Q) (Issue 3.) -- $85.00

The Process Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorder and reviewed with a view to ensuring that the deviancies (within permitted tolerances) that exist are random and not a trend that will lead to out of specification produce being produced.

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