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[Music] now we move on to the next concept of equipment management equipment in the post-purchase face so we talked about equipment purchase and in the earlier video we talked about the pre-purchase planning okay so that itself was a very extensive concept and now we move on to the next concept which is the post purchase face so as soon as an equipment comes in what do you do do you just start working on it no there are certain things that you have to do with the equipment before you actually put it for patient reporting so once the equipment has been purchased and delivered to the laboratory we need to establish with confidence then the equipment is capable of operating within established limits of an tolerances this is achieved through insulation qualification operational qualification and performance qualifications three points that we have to understand in detail so what is IQ or insulation qualification IQ ensures that the equipment delivered means the DQ specifications and it is correctly set up in the customer lab as plat IQ is a responsibility of the manufacturer so once again the equipment has arrived and it needs to be set up correctly and this process setting it up is called the IQ or the installation qualification and it is the responsibility of the manufacturer IQ encompasses detailed instructions for setting up the equipment these are found in the insulation and the operating instructions manual along with interface descriptions insulation diagrams etc IQ also verifies that any subsystems or the ancillary systems have been delivered installed and configured in accordance with the manufacturer's specifications or installation checklist never open an equipment package before that the insulation team arrives the process including any damage or defects should be documented and signed by both the manufacturer's representative and the laboratory representative very important do not open the curtains before the insulation team arrives similarly all spare parts listed in the supply list should be checked verified signed and countersigned and this also a very important thing that you have to inventories your sir spare parts and you keep it in a place under one person who will be responsible for the spare parts and which can be retrieved whenever required the this entire process of installation with all documents should be filed these files should be available in the lab for the entire life of the equipment so we talked about documentation in the first video how is cross-cutting how documentation is required in every aspect of your equipment management starting with your urs okay just to recap you have three or four equipment that you have checked out you have filled in your urs forms you have done the DQ whereby your one of your equipment has satisfied all your conditions and therefore that becomes your that is what you of ordering for so that's your first document that you're keeping now that the equipment has come in you have your IQ as the first document as part of your equipment management thing once ur equipment arrives in your lab there's a sample IQ documentation document which is shown here please look at the components of what this particular equipment requires as part of the insulation process so once the IQ is complete you go to the next part which is operational qualification operational qualification is also the responsibility of the manufacturer that is once the protocol for IQ phase has been met operational qualifications are oke Oke is performed to check if the equipment is operating in consistence with the urs or the user requirement specification and also with the manufacturer specified operating ranges or the claims of the manufacturer to just say that again your IQ is over the equipment is installed you have made your inventory record and there are certain steps now that we have to go through to verify that the manufacturers claim and your the urs requirements are being met so these are done through a few processes of calibration verification of operating procedures and maintenance program development and training so we'll go through that in this section so during the OQ phase all the items in the test plan are tested individually and their performance is documented the operation specified in the menu as far as testing is consider us are configured calibrated and verified using quality control material during this process the quality and technical managers and the manufacturers technical support team should work together in consensus for the OQ it's not though it is a responsibility of the vendor it is also very important that the technical team still invested in this process the document ok also should be signed by the manufacturer and countersign by the laboratory training of all operators is also part of this vital step and should be completely documented a sample OQ document is shown here the sample ochio document includes operational qualifications reference OQ protocol and engineers and customers name with signature and training and skill development also it also sometimes is called the personal qualification of PQ so the since it's getting confused with the performance qualification disturb generally is not used but this is also very important that your personnel are qualified for operating the equipment during the OQ after the OQ and before embarking on the next step of equipment acceptance it is imperative that the training and skill development be built into the system all staff who will be concerned with operation monitoring and maintenance of the equipment should be trained in all aspects of the equipment by the technical support personnel so this is the very another key component so after OQ you have to go to the next part is the training part of the oke not after okay it's part of the OQ that the training it should be trained all staff should be trained develop a written plan for calibration performance verification and proper operation of the equipment establish a scheduled maintenance program that includes daily weekly and monthly maintenance tasks designate those authorized to use the equipment and when it is to be used these are all important things that you have to plan before you hand over the equipment your frontline worker this is this part becomes a responsibility of the technical supervisory team to understand and write a plan for calibration performance verification and proper operation of the equipment and to make a plan for maintenance what is your daily maintenance requirements weekly ice needed maintenance requirements please ensure that these things are adequately made and developed before you hand over the equipment for routine work designate those authorized to use the equipment and when it is to be used designated personnel should be trained in all important aspects of the equipment operation maintenance and calibration record-keeping quality control recognizing flags and alerts shown by the equipment basic troubleshooting etc their name should be clearly indicated on the equipment this is another requirement is to have that authorization label on that equipment that what you see in the sample label here that these are the following frontline workers or technicians who are authorized to use this analyzer and then this should be approved by the director of the lab or whoever is competent to authorize this kind of equipment handling so that's another important part of your OQ so your equipment is now ready it's been installed it's been operationalized by dude for configuring the tests and calibrating it and all operations are now ready to go so your OQ is now done so is it over now not yet it's not over till you do a PQ or a performance qualification PQ is the documented proof that the equipment performance in the customer facility is as expected mates the users requirement though the DQ IQ and OQ have passed it still is the duty of the user or the laboratory to verify the performance of the equipment on their sites and this is because as an equipment undergoes shipment it is expected that some alignments could have changed that's a verification step performed as performance qualifications becomes imperative and the performance qualification here includes testing new samples and analyzing data establishing the stability for temperature controlled equipment and validating the performance of with parallel samples so this is a very precise way of saying doing the performance qualification however we would like to direct you to the clsi guidelines on performance verification so I'll just at this point I would like to say one thing this accept this entire process of IQ oqp Q's together is termed as acceptance testing or verification by the ISO and this is all part of your laboratory quality management system how to put the equipment to use optimally so now going back to the performance qualification manufacturers provide performance characteristics for testing methods using their kids or instruments in the package inserts or operators manual however laboratories need to verify the manufacturers performance claims and demonstrate they can get the same results using the kits or equipment in their laboratory you say their frontline worker so that is the concept of performance qualification so this is not an done in one or two days it generally takes up to 20 days at least couple of weeks before you can actually evaluate the entire performance of the machine and ideally it's only after this performance qualification that it should be put to use for patient reporting there are seven performance characteristics that should be evaluated before reporting results of a new test or a method as for clsi guidelines include precision which is a degree of dispersion between repeated measurements using the same measuring system accuracy which is a measured bias and comparability which is a measure differences linearity over the measuring interval or analytical measurement range limits of detection and limits of quantification on analytical sensitivity specificity or interference reagent or an sample and analyte carryover biological reference interval or clinical decision value which is interpreted in information so these are the many things that need to be checked through before you say that this machine can now be used for patient reporting once again I would like to direct the listener to the videos that we have on quality control and the module on method evaluation and quality control where we have given more details of this and there is also a statistical tool our for statistical tools in that for method evaluation one for accuracy one for precision or repeatability and one for linearity and for change of biological reference regions so there are many tools which are available in the turk toolkit and there is also user manual which actually describes the entirety of this process of method evaluation and I would like to direct you to that particular tool to understand more about the performance verification component and whether to reiterate do not allow the use of the equipment for patient sample testing and reporting before it is completely installed performance is verified and testing personnel are adequately trained at this point we I need to say one line about change changes of the equipment you have installed the equipment but you have sort of you want to move it from one room to the other or maybe move it from one place in the room to another place at such places also you need re qualification this Ricola fication is also carried out after any major repair or modification or software up tradition or because of Aging maybe like in once in a year just to ensure the fitness of purpose this performance qualification part becomes part of your change qualification also every time you do a change you need to manage the change by using doing the performance qualification once again so in most of the laboratories the performance qualifications are done for precision accuracy linearity these are the three competence which are done also biological reference ranges are also important to redo after any kind of even after the installation because your population may be I'm just talking about biological reference changes right now because your population may have a different biological reference range so that again requires to be verified due through performance qualification once your equipment or system is installed and the others like a limit of detection and specificity of our interference are generally we you take the manufacturers claims though it also there are guidelines to do that and sample carryover also is something that you need to clarify especially when you are talking about cell counters so there are tools for this carryover also in that the software that I'm talking about so now that we have discussed about the process for equipment management pre and post purchase recapping pre-purchase thoughts post purchase activities and we have understood up until this point when you it is going to be introduced into service we have to understand a couple of concepts more one is equipment labeling and identification each item of equipment is uniquely labeled marked and identified as shown in the sample label here model number and serial number are generally located at the back of the equipment all what you need to do is to write it up on the front the reason why this is important is when there is a breakdown or any other reason for which you have to communicate with the manufacturer the first question they'll ask you is which model is it depending upon the model they'll be able to provide remote support through the telephone or to help you troubleshoot such mechanisms greatly reduce it down time another question they will ask for is the serial number it is a serial number that will help the manufacturer to identify and track your equipment with regard to warranty the availability of maintenance contracts like same C or CMC before they extend this support making this is why you need to write down the model number and serial number on the label which is on the front of the Mac Woman and marking the preventive maintenance and calibration status is also an important aspect that will alert you to the upcoming schedules this may be put as a separate label as well as this needs to be changed frequently another piece of information that I have already talked about which is to be displayed on the equipment on all equipment are your authorizations for use I just said in the last five minutes please go back to that understand why equipment authorization is required and before we move on to the next concept in equipment management we need to talk about the documentation for new equipment we're not talking about general documentation I'm just talking about documentation that should be in place before we actually start working on it the Beeb already talked about a few of the documents for purchase and pre purchase and installation documents operational documents all the PQ documents now by this time you have already accumulated a few pages of work like maybe like 50 50 60 pages of work through all these things and an additional to that you also need to develop your SOPs SOPs should give use and maintenance of the equipment how to each test is done everything should be in place before the equipment starts functioning at least by the time that it is put into general use SOP should be ready and in addition to else SOPs you may need to develop both disk instructions to enable your frontline staff to have easy access for troubleshooting I am showing troubleshooting a page from a W show manual so similar this is downloadable similar works was troubleshooting tables can be put up a server disk instructions also about the QC rules and your flags all these things should become your work disk instructions for an equipment for the easy understanding of your technical stuff and then additionally develop formats also to capture the data to be evidenced for from the equipment regarding each of the activity that is useful for the functioning of the equipment these formats should also be developed upfront and given to your technicians develop also a system for recording the use of parts and spare parts and supplies an inch short to reiterate create an equipment inventory lock which will include all information about the instrument type model location in the lab date of purchase manufacturers service engineers contact details warranty period spare parts all these should be Mendon additionally your people urs that you will have used your DQ IQ q PQ entire documentation your SOPs plus your workbench shades plus your formats all these documents together should tell the story of the equipment in your lab and develop detailed maintenance schedules including daily weekly monthly annual as required maintenance this is all part of your formatting and this everything together should be available for each equipment as long as equipment is in service and that while you are taking it out of service even your condemnation record should be there in your laboratory and once all aspect of the installation process i qo q PQ and training is completed the machine can now be put to use to report patient samples you