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).
use of the Failure Mode And Effects Analysis.
FDA Failure Analysis Template's: A
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
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
FMEA DOCUMENT's: 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.
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.
Process FMEA DOCUMENT's:
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.
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.
Percentage Reduction in REN
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?
Basic Validation (Registration)
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.
For Your Security We are Now TLS 1.2 Compliant
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
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.
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 & PQ 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.
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.