Complexity is king here. Decisions were made on the fly for product design, now they are written in stone even though it is clear they cause more problems than they solve. To fix the problems, you need to go through a very complex change control process and make your case to a "change control board" which is made up of people who have never set foot in the lab and try to explain why you want to make a change. It is usually easier to wrestle with a broken process than to try and fix it.
Documents are way too complex, and full of typos. Those typos create impossible situations, which lead to deviations. Names and part numbers frequently get mixed up so that they point to products that do not exist. This caused typos, relabeling events, and general chaos.
Our QMS system is broken. It has obsolete documents that are shown as effective, multiple effective document versions, training on new document versions is not automatically assigned, training emails are not sent, so you have to manually check your training every week to stay in compliance. Every time a document overhaul is attempted, things fall through the cracks because no one reviews the documents, and the old documents are not obsoleted.
There are too many systems with too much information and none of them talk to each other. Each of these systems are managed by a different person or group, and none of these systems are connected. The result is typos, missing information, and complete disorganization because there is no "gold standard" document or system to refer to.
Deviations have been weaponized by the QA department. QA has no subject matter experts and makes no effort to understand our technology. QA is immune to deviations. If operations is deficient in training, they are assigned a deviation. When QA is deficient in training, they are not. QA also changes the definition of deviations, assigns them arbitrarily, and finds new things to make deviations which were not deviations before. Keep in mind the vast majority of these deviations are technicalities which stem from the fact that the documents we use are so complex and practically guarantee deviations.
Operations people are not trusted by the company and it causes resentment. Recently, all music was banned in the labs because it was an easy target for why so many deviations were occurring (remember, it is the complexity of the documents and the QMS system that is the real root cause for most deviations). I have never been in a lab where music was not allowed, especially in operations. Keep in mind the deviation rate did not significantly change after music was banned.
