Looking at the lecture, I can see that Quality Assurance builds the methods, rules, acceptance criteria, and systems that prevent errors in medical device development. On the other hand, Quality Control executes the rules, measures results, and sees whether products meet the defined criteria.
I think a danger lies in how companies often lean too heavily on Quality Control because it produces visible results with the pass and fail data. Quality Assurance’s impact is harder to quantify on the surface, as there is no data associated with the making of the rules. However, without Quality Assurance, Quality Control becomes a never-ending fight. The PDCA cycle makes sense in this case, as Quality Assurance governs the Plan and Do, while Quality Control manages Check and Act. However, a disruption in communication between the two departments could lead to major issues. A clause outlined in QA that is not fully understood by QC could lead to a false pass or a false fail, which can be amplified down the line and possibly create unsafe devices. Thus, I think QA and QC should be integrated more for efficiency, but I think there should be some separation to enforce objectivity in reviews.
How do you think this communication issue can be resolved between Quality Control and Quality Assurance? Have you had any negative experiences in these departments due to a lack of communication?
In the strict sense for the last sentence and technically, I don't think I've ever been in the position to have a negative experience with QC and QA. I agree that the PDCA cycle highlights the dependency of each other (QC and QA); since if QA is not deifining or not clearly defining the "planning" and "doing" then the QA's checks and balances might be based on faulty ground. Communication then breaksdown between the group and it can snowball out of control. Perhaps one resolution could be cross training and ensuring that documentation remains similar across the board. Almost similar to post 1 of having a unified guideline or framework. Additionally, QA staff could involve QC staff in the early drafting phases or revision phases, that way there is an ensuring understanding for both sides of the aisle. A lot of this documentation could be shared electronically as well in a secured network if possible so that both parties could access it for viewing at the very least.
ARA
It's true that having things be more measurable makes it easier to provide clear results. One way I see of preventing that can be to create a checklist between QA and QC that explains what standards QA expects, and QC can confirm they know how to test for said standards before the production starts. For example, sample sizes, measurement tools, tolerance can be the way that QA has measurable problems that they are looking out for. If either QA or QC changes something, the checklist will be updated and preapproved by both sides before continuing. How do you think companies could make sure that those updates are communicated instantly to avoid mix-ups?
As is the case for any team, communication between members is key to success. When scaled to a larger size, communication between departments is how a company knows its staying on track and that their product ultimately reflects their mission statement. While I don’t have any experience in QA and QC I would imagine that communication between them can be hindered by organizational culture rather than technical barriers, especially if the company is looking for shortcuts to speed up their product release. One way to strengthen this communication is to implement cross-functional review boards that include both QA and QC during every step of the project management process, from initiation to closing. When both sides see how their decisions impact production outcomes and regulatory reporting, collaboration should naturally improve. In a more non-procedural way, communication can also also take on the form of digital dashboards that allow for quick updates between the two departments.
Some of the communication troubles between QA and QC because integration of the two is tricky due to the nature of how they deal with quality. QA focuses on being more proactive, while QC is more reactive. QA is there to identify problems before they occur in a medical device, while QC identifies the problems in the medical devices already built. In an ideal world, QA and QC should be complementary and many companies do strive to keep it this way. Most of the communication troubles most likely do not stem from QC and QA directly, but rather from requirements which may not be clear and documentation which may be lacking critical information. This can be why false passes and false fails occur, and identifying these issues early can prevent a communication issue from compounding further. Ensuring that documentation is clearly defined is important for minimizing inconsistences across QA and QC.
