All too many times, our clients claim to know exactly what equipment they need to perfectly package their products. They are so excited to move forward with projects and purchase equipment that many things get overlooked. It takes more than knowing that a pill will go into a bottle verses a blister pack to choose the proper piece of equipment for your process and facility. This is where a well-written User Requirement Specification (URS) comes into play.
The URS highlights the needs of the end-user, as well as any regulatory requirements that surround the particular environment or industry. This includes, but is not limited to, calling out any special functionality, output speeds, input materials, alarms, etc. It also means setting limiting factors of the facility in which you will operate. It would be tragic to find out your brand new, state-of-the-art filling line runs on 480V electric and your facility is only equipped with 230V. Or that the line is six inches too long to fit into the operating space that has just been renovated to fit your new equipment. A poorly-written URS can result in miscommunication between the end user and the potential supplier/vendor, which in turn can lead to time wasted rewriting documentation or in a worst case scenario, producing the equipment not suitable for the process.
It is important to get the input of all user groups when writing a URS, from operators to facility personnel who will be maintaining the equipment. Each group will have a vested interest in how the equipment operates.
The URS also sets the validation criteria. It is part of the lifecycle documentation (URS, FDS, SDS, FAT, SAT, IQ, OQ, PQ) that defines what the machine does and how it does it. Because there are many lifecycle documents, it needs to be understood that very specific details are not necessary and sometimes detrimental in a URS. Everything in this document will need to be formally verified in later testing documents. Stating that a machine needs to put 50 tablets into a bottle can be verified. Stating that machine must be delivered by January 2016 is not. That’s what purchase specifications are for. Purchase specifications fill the gap between lifecycle documents and “preferences” for the machine. Only put what the machine should do in the URS; put vendor requirements and component preferences in a purchase specification.
The next time you want to purchase a piece of equipment, take the time to write a proper URS document. Doing your due diligence up front to will make your project go more smoothly on the back-end.
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