Years ago while launching a global service organization in the pharmaceutical manufacturing market I came across a remarkably well structured approach for managing almost any product or service development process. I’ve employed a version of this ever since, and have never been disappointed with the approach. It was originally developed by the European Society of Pharmaceutical Engineers as the preferred approach for specifying, manufacturing, installing, and validating custom manufacturing equipment in this highly regulated marketplace. It works just as well in other manufacturing, consulting, or service environments.

The approach involves six inter-related steps, and as I mentioned, it can be applied to most any project to help maintain stability, elevate transparency, and avoid costly missteps late in the process. There is a visual model that relates to it…think of a V, with the first three steps beginning at the top of the left hand side of the V and working down to the bottom. At the bottom is the actual execution of value creation. The last three steps then work their way up the right hand side of the V. Each phase of the planning and validation (or acceptance) process relates to the phase on the opposite side of the V.

It begins with the creation of a User Requirement Specification. Working closely with the customer, end user, or constituent your project is intended to serve, you identify and document the optimum outcome or application they are seeking to achieve. This will drive the next phase, but it also provides a specification document that will drive final validation of acceptance. This is invaluable, especially if you’re delivering a long-term project in which the players within your customer environment may change before you complete your project.

Next, comes the Technical Specification. This identifies and documents how whatever you’re attempting to build or create will function to meet the User Requirement Specification. In the pharmaceutical manufacturing world, this provides the document for testing the operational qualification phase upon delivery to ensure the equipment is functioning properly. In a service environment, it can provide parameters for process stability, a key driver of sustainable quality.

The Manufacturing Specification, which is the next step, is driven by the Technical Specification. This phase identifies and documents the how to parameters and can be adapted for any creative project. Once this is set, the execution of whatever one is working towards is then initiated. In the pharmaceutical world, this will also provide the document that is used to qualify proper instillation and calibration. In a service environment, this will identify and document the necessary training and preparation for delivering the designated service.

Now you’re ready to deliver on your project. For hardware, you would first conduct the Installation Qualification (driven by the Manufacturing Specification). In delivering a service, you would engage buy-in and agreement with the framework of the deliverable service. Once this is met, the next phase, the Operational Qualification, ensures the Technical Specifications have been satisfactorily met. The final phase relates guides the Process Qualification, ensuring and documenting the intended application of the product or service is delivering the desired value expressed in the original User Requirement Specification.

There are several reasons this works so well. First, it ensures the developmental process or project is not being created in a vacuum…you’re working directly with your client or customer to design a solution that meets their explicit needs. This communicates tremendous value to your customer and builds relationship.
Second, by checking in with the customer at each phase of development, you can catch possible miscommunications early in the process where a small change is easy and affordable to incorporate.

Third, this enables change controls to be implemented at the very beginning of the process. By securing buy-in and approval at each step of the developmental process stability and profitability are ensured. Any changes requested once a step has been signed off require a formal change request, and the associated cost of that change can then be passed along to the client. You don’t look like the bad guy here. If the customer wants a change, there’s a cost associated with it. If the customer doesn’t want to incur the additional expense, they can forgo it by sticking to the original plan. This also helps the client or customer seriously evaluate changing on a whim. If it’s important, then it’s worth the additional investment.

Finally, by following this type of approach, you’ll be learning more and more about the needs of your customer that you can fulfill in the future. Needs they may not even be aware of at the time. This level of customer engagement builds wallet share and significantly lowers your costs of sales.

Do this well and you’ll become a valuable asset for your customers, one they couldn’t imagine living without!