In general manufacturing, it is guided (or suggested) by the ISO 9001 standard. For medical devices, quality is managed (or better described as mandated) by ISO 13485:9001. Though the remainder of this blog will refer mostly to medical devices, the practices hold the same for general manufacturing as well.
In general manufacturing, adhering to ISO 9001 is important. For example, if CompanyX manufactures a cell phone case for CompanyA, then CompanyA will want to make sure the cell phone case fits their model phone components correctly. If CompanyX doesn’t care that the molds for the cell phone case are wearing down so that the cases are no longer fitting well or are not as aesthetically pleasing, then CompanyA will receive bad customer reviews; resulting in sales and market share decreasing over time.
For FDA regulated manufacturers, ISO 13485 protects people. Simply put, any hardware put on or in a human body (i.e. band aid, catheter, hip implant, dental post) or any piece of equipment used to analyze/diagnose a condition (i.e. blood analyzer) needs to “go through the ringer”. Devices don’t have to just “fit”, they need to be repeatedly validated and verified in a way that makes the FDA happy. Any change to a process, part, material, etc. has to be justified and validated. (Side note: Yes, a band aid is a medical device.) Though some in the medical device and pharmaceutical industries may feel differently, the sole purpose of the FDA is to protect people.
Making sure everything is consistent is simple, right? Not so much. Machines wear down. People change jobs. Suppliers modify parts and techniques for whatever reason. Original Equipment Manufacturers (OEMs) get bought out. This is where Quality comes in.
To start, Quality Assurance (QA) and Quality Control (QC) need to be explained:
- An organization’s Quality Assurance program provides the structure that dictates things like (a) who the reviewing (auditing) agencies are, (b) standards that are followed, (c) the needs for daily tracking of inventory and production, (d) the methodology behind any product identifiers, (e) when and why review/auditing occurs, (f) how documents are approved, tracked and stored, and (g) who is responsible for the quality reports, etc.
- Quality Control is the development, implementation, and tracking of the procedures that follow the structure of the QA program.
Case Study: Return on Investment (ROI)
It is difficult to put a price on the phrase, “Well, I didn’t get sued today….” Where quality can be quantified is the long-term costs of wear and maintenance of machines. Maintenance schedules are part of a QA program. For example, an injection molding system costs $80k. If the system is only good for 7 years with $10k of annual maintenance with 30 days of down time, that affects production annually, and incurs an installation (and removal) cost of “x”. From a Quality perspective:
- The costs of the system can be tracked
- The efficacy of the system can be tracked
- Long term economic analysis can determine whether that system is a good or bad investment
- Once you include labor costs and utilities, then you can fully account for overhead
- Capital forecasts can be made for your organization
Quality reports usually come out of Operations Departments, but should be correlated to both Sales and Receiving Departments. All of this ties into process improvement tools like Lean and Six Sigma.
Quality is a way for an organization (big or small) to:
- Have an organizational structure in place to keep track of all manufacturing details
- Ensure that procedures are in place and followed so that when someone is no longer employed with the organization, a new individual can pick up the pieces without a change to the product
- Track suppliers
- Track production lots
- Track wear and tear on equipment
- Track employee performance on the production line
From my experience, management cringes when they talk to the Quality Manager or Director of Quality. They are the necessary “whiners” in the organization. Their jobs are important. They keep an organization out of trouble. The difficult part to avoid is that, over time, their voices turn into white noise. Nearly every organization I have worked with has the talent in-house to solve their daily problems. However, there is a communication gap between the upper management that coordinates strategic goals with the people conducting the actual work. The white noise of daily tasks and meeting deadlines often drowns out the need for updating equipment, implementing safety measures, and enabling innovation. Outside opinions from a consultant or evaluator/auditor are beneficial, so that an organization can receive a fresh point of view and voice to filter through the daily noise.
Keystone Scientific, Inc. is in the business of connecting clients with the right people having the right skills to meet their project needs. How can we help you achieve your goals and solve your project problems? Please feel free to reach out to our team by calling 814-205-3393 or contact us online.