There is an old saying in Quality Management: “If it’s not written down, the event never took place.” All businesses need a Quality Management System, but many do not have one, and if they do, it may not be managed very well.
What exactly is a Quality Management System (QMS) and why is it necessary? A successful QMS consists of written and controlled procedures. These procedures are the basis for auditable events performed by either external or internal audit teams. An effective QMS will identify key process steps and prevent most failures before they occur. It will protect your supply chain, your brand, and most importantly, your consumers.
There are several steps involved in creating a solid QMS. These include the following: statistical tools and control plans, Failure Modes and Effects Analysis (part of APQP, or Advanced Product Quality Planning), systems validation protocols, and Current Good Manufacturing Practices. The first step is to start off with a flow chart or process map.
A flow chart or process map is one commonly used statistical tool that details the path a product would take as it goes through the manufacturing process. It is easy to understand and a very useful method to help others visualize the “whole picture” in a step-by-step format. It identifies possible problems that could occur as well as quality check points and documentation expectations. Once the process steps are written and the flow chart is approved by all departments involved, it becomes a formal control plan. The project and quality assurance leaders then sign off or approve the control plan with the final process steps for the product. The next critical step is Failure Modes and Effects Analysis, or FMEA.
FMEA helps to identify potential failures as to their severity of impact, likelihood of occurrence, and your ability to detect the failure. An FMEA team, on a scale of one (least) to ten (most), will estimate the likelihood of occurrence, the severity of impact for the potential failure, and the likelihood of not detecting the potential failure. The FMEA team will identify high Risk Priority Numbers (RPN) as the basis for the development of written quality procedures and controls. Measurements will be taken based on the RPN results throughout the manufacturing process. NASA used FMEA to identify the potential failures that might occur in getting the United States astronauts safely to the moon, and back.
To assure that your measuring systems do not induce errors into your process, both manual and electronic measuring devices must be calibrated (with pre- and post- calibration readings recorded for critical features). These measurements are part of gage R&R (gage repeatability and reproducibility). Gage R&R is expressed as a percentage of measurement error. Most of the robust measurement error readings are less than 10%, but for critical jobs, such as pharmaceutical production, error readings are as low as 3%. All of these factors determine the risk involved to consumers. These “up front steps” also eliminate or greatly reduce expensive recalls, loss of confidence in the company, and regulatory action.
Some Quality Management Systems express quality in Six Sigma terms. Six Sigma’s main purpose is to remove the causes of defects or errors and minimize variation in manufacturing processes. This reduces costs and increases profits. It involves creating a team of individuals that are trained in specific areas of expertise. A six sigma process is measured by the number of defect-free products manufactured, which is expected to be 99.99966% or less than 3.4 defects per million opportunities. In order to achieve this, these processes need to be validated. This is referred to as Systems Validation Protocol, part of any company’s Validation Master Plan.
A Systems Validation Protocol (SVP) consists of IQ-OQ-PQ validations. It tests the QMS for conformance and compliance. IQ (Installation Qualification) is documented verification that the equipment, system or subsystem has been properly installed and adheres to applicable codes and approved design intentions for the unit (machine). It also validates if the supplier recommendations have been suitably addressed. OQ (Operational Qualification) is documented verification that the equipment, system, or subsystem performs as specified throughout representative or anticipated operating ranges. At some facilities, there may be overlap between IQ and OQ.
PQ (Performance Qualification) is documented evidence that the defined process or system functions as intended and produces intended results under normal operating conditions. This may also be referred to in terms of process capability (anticipated number of defects per million).
Even the best QMS will fail if it is not enforced. Trace audits are vital after a system has been established. Trace audits ensure the following:
• Operations are carried out in accordance with the written and approved QMS
• An adequate quality system is established and maintained
• All personnel are trained properly
• Training records are updated and maintained
As an example of a trace audit, let’s say that you make 30 products for your customer. The customer comes to perform an audit. The customer audit team wishes to see your systems’ documentation for product #A1234 and product #A1236. The customer’s audit team will then “trace” your documentation through all of the steps (training, APQP, FMEA, process design, gage control, first article inspection and approval, in-process inspection, finishing, final inspection, retention period for quality records, etc.). Because you do not know in advance which product number(s) the customer will audit, all of your quality records had better be in full compliance.
Many businesses (especially pharmaceutical and biotech companies) need to ensure that the products they produce meet specific requirements for identity, strength, quality, and purity. This is referred to by the FDA as current Good Manufacturing Practice or cGMP. Companies that operate under these regulations also expect their suppliers to do the same. Establishing and maintaining cGMP compliance is not an easy task. It takes a dedicated management team, well trained and committed employees, routine audits, and most importantly, a solid and well written Quality Management System.