One of the challenges for young organizations is developing a “feel” for quality. It’s a subjective thing. After participating in activities done well, you develop a rhythm-an inner sense that things are flowing as they should (or not). Call it a “gut feel” if you will. One of those “gut feel” items that I look for in an organization is the boredom of approving validation deliverables (validation plans, test plans, summary reports, etc). There is just no excitement to it in a quality-mature organization.
This is exactly as it should be, because all the approach discussions, the debates over technical details and the regulatory requirements were completed early in the life of the deliverable. The interactions that matter happened up front, so that the final version for approval moves quickly. My way of saying this is that “Quality is a front-loaded activity”
Conversely, quality-immature organizations are still debating details far into document development. If an analyst is trying to resolve the handling of test defects after testing has started –for whatever reason—that is an immature organization. This is not saying that unplanned events can happen—they will—but even then, mature organizations already have a process for handling unplanned events in their plans. Immature organizations focus on the time to get to deliverables, at the expense of slower execution due to unplanned events, unidentified project risks and technical limitations.
In a Quality-mature group, most of the effort is expended early in the process. Relevant parties are identified and brought together to create processes that will produce the final product. Risks will be identified and managed in plans and technical limitations will be recognized and included. Sufficient time will be permitted for adequate technical reviews.
This early planning takes longer than you first expect, but results in smooth execution with fewer issues. It also creates a process that can be repeated, to extract even more value from the expended effort.
Let me offer another example: releasing a batch of material. It is a lot of work to set up an electronic specification management system compared to manual release. You must review regulatory submissions to get specification commitments that have been made to various customers/regulatory authorities. This document research time could have been used to manually release several batches; but in the long run, the specification research will return its cost multiple times over as batches can be compared against multiple country/customer release specifications at the push of a few keys. Hours of front-loaded data research result in a rapid (and error-reduced) quality process.
More work up front, less work at execution and approval time: quality is a front-loaded activity.
Originally published by Mark Newton (Principal) on 25 June 2018