Reason #1
Your Quality Management System can become overly complex over time due to excessive layers of unneeded documents, procedures, forms, systems, subsystems, and red tape. When a firm is subjected to an external audit, many times instead of looking at the overall QMS, management elects a short-sighted route to fix only the noted issue. This route fully neglects the broad holistic view. The net result is a system of unconnected layers of document revisions that handcuff the firm into many preventable traps for internal and external auditors.
In my experience, this short-sighted route is the default option taken too many times. At first glance it seems like a quick fix but it does no one any favors in the long run. On the contrary, it is a major reason that Quality Management Systems fail, placing the firm in danger of remediation and costing more in the end.
Reason #2
Continuous regulatory demands can create temporary holds on TQM. Regulatory actions, such as general quality improvement initiatives and continuous upgrades can create periods of static hold preventing positive change control measures from moving forward.
Non Regulated environments allow more freedom and flexibility to move down the path of TQM. You will find that lean, six sigma endeavors overall, can effectively complement your firm's growing and maturing QMS.
Reason #3
When misinformed leadership sets up KPIs on CAPAs with unrealistic metrics, the firm will begin to engage in ineffective corrective and preventive action programs. An external auditor will commonly find issues with this. Frequently, the organization elects to document every nickel and dime nonconformance leading to an uncontrollable amount of CAPAs which overwhelm the quality system.
This particular issue often leads to late and overdue CAPAs that force management to review and approve extensions to effectively be able to complete the required CAPA phases in a timely manner. Misinformed leadership on the front end causes these phases to be late in accordance with the poorly planned metric which was likely unrealistic from the start.
Reason #4
A healthy QMS does not need to employ complex and time consuming programs to be successful. It is a false impression that utilizing expensive and complex electronic applications for managing key sections of QMS (ie, training, capa, document and change controls) are necessary to be successful.
Companies are often distracted by the thought that expensive electronic applications using valuable resources should be the focus. When in effect, the focus should be on the actual objective of good training, capa and change control processes. There is no need to focus on managing software when you are managing the intent and organic requirement of the regulation or ISO standard that is applicable. This misdirected focus puts pressure on the system that is juxtaposed to lean thinking and ongoing improvement to the organization.
Reason #5
Neglecting to break down functional silos in an organization will hinder a QMS from being built robust from the ground up. Every process that will be part of the QMS must be assessed with an eye to how it interacts with other key processes in the organization. If the QMS is built in silo fashion it will not be sustainable and will eventually fail to pass a system level quality audit.
Bear in mind that each process must be examined with a filter that looks at internal and external customers of the process as well as internal and external suppliers commonly called the SIPOC approach. This will lead to long term success as all affected stakeholders in the process are considered for how they are sequenced and how they interact with the process being examined.
Message us directly if you recognize your firm has specific needs surrounding your QMS or that your process is not taking silo functionality into account. We will be happy to give you a free 30-minute consultation to help get you on a wise, well-structured path to a robust solution and/or ISO certification. QMS@qualmetrica.com
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