I know and have experienced the transition from paper-based systems or between integrated Enterprise Resource Planning (ERP) and Quality Management Systems (QMS) in companies. At one company they transferred to IFS and at another, they transitioned from CMS to Windchill, as well as XA to JD Edwards (JDE). In both cases, quality control (QC) and quality assurance (QA) had to assure the proper transition between systems.
The company has to ensure data migrates properly and records are maintained. The impact on training and other processes has to be assessed.
QA specifically has to establish new metrics for assessing quality performance and monitoring compliance. They must also develop new validation protocols for the ERP/QMS system itself. In addition, they need to prepare for any audits during the transition and after with clear explanations.
QC processes may require new inspection protocols or methodologies based on the functionalities of the new system. Integrating real-time data analysis for quality checks can also pose a challenge.
Transitioning from paper or between digital formats can lead to difficulties in document retrieval, version control, and compliance with regulatory standards. Document control teams need to ensure that all documentation is properly migrated and that new procedures are in place for ongoing management.
Training personnel across different functions (QA, QC, Document Control) to utilize the new systems effectively can be time-consuming and may require tailored approaches for each team.
As companies move from paper-based systems and switch to or between different ERP/QMS systems, what other challenges do quality units face, and do these challenges differ across the various tasks related to QA, QC, Document Control, and Training? Another thing that is more recent is the crowd-strike incident, which impacted the computer systems for many companies. How can companies prevent or minimize the impact of incidents like this?
I look forward to hearing your thoughts and experiences on this topic!
Maintaining system interoperability with third-party applications is another difficulty when switching ERP/QMS systems. Integrating specialized solutions for maintenance management or supplier management with a new ERP/QMS system might be difficult.
Data silos can result from systems not communicating, making it hard to see supply chain quality. If your supplier quality management system doesn't link with your new ERP/QMS, your QA team may have trouble tracing non-conformances to suppliers, delaying corrective measures.
This difficulty involves making sure legacy data from previous systems and new data from the integrated system are consistent and useable. Data format or categorization differences between systems may cause compliance gaps, especially during audits.
Companies should have strong cybersecurity processes to prevent crowd-strike breaches. This includes regular software updates, end-user phishing and other attack vector training, and MFA across all systems. An incident response plan for quality systems can minimize quality process disruptions after a breach.
Switching from one system to another, whether it's going digital or moving between ERP/QMS platforms, comes with a lot of challenges, especially for teams like QA, QC, document control, and training. Data migration is a big deal because if something goes wrong, you could lose important info or run into compliance issues. QA teams have to figure out new ways to measure performance, and QC might need to adjust how they handle inspections. Document control needs to make sure everything is organized and moved over correctly to stay compliant. Plus, training everyone on the new system takes time, especially since each team will need different kinds of training.
On top of all that, cybersecurity is a big concern, especially with incidents like the CrowdStrike one. Companies need to stay on top of updates, run regular security checks, and have solid backup plans in place. Training employees on security best practices is also important to help prevent problems. I'd love to hear how people in the industry have tackled these issues and what solutions have worked for them.
I completely agree with what’s been said about the challenges when switching ERP/QMS systems, especially with data migration, staying compliant, and making sure everyone’s trained. One thing I’d add is how important it is to keep business operations running smoothly during the switch. You can’t afford a lot of downtime, so careful planning and rolling things out in phases can really help.
Another key point is making sure teams communicate well throughout the transition. Since quality control and assurance are so tied to everything, having IT closely involved with these teams can make a big difference. It helps ensure that the tools used for data migration work properly with old systems, which reduces the risk of losing data or having it get messed up.
On the cybersecurity side, I agree that things like multi-factor authentication (MFA), regular updates, and employee training are essential. But I’d also suggest doing regular penetration tests to find any weaknesses before hackers can. That kind of proactive approach could prevent issues like the CrowdStrike incident from happening.
I’m curious, though—how do companies handle training employees on both the new system and new security measures without overwhelming them? It seems like a lot to manage all at once.
Cybersecurity is certainly a vital consideration when migrating from paper-based to digital systems. Along with cybersecurity, another important factor to consider is data integrity. QA and QC departments must ensure that the integrity of data during migration remains sound. This is especially essential when considering past historical data, which can be required to be pulled for audits. QA ensures that data isn't lost and QC ensures that quality checks and test results are preserved accurately. On a similar vain, document control must remain the same and link well to the new system. Version control must be heavily focused upon and a major difficulty lies in linking the correct document versions to historical records. If an old revision of a test method was used for historical data, the migration from paper-based to digital must reflect that. Training for all employees who work with the new data retrieval methods is also required. Improper access to data could lead to massive traceability failures.
I previously mentioned audits. When transitioning between paper-based and digital systems, it is also imperative to remain audit-ready throughout the entire transition. If an unexpected audit begins, the excuse of "We're currently transitioning to a new system" is not acceptable. Old records must always be accessible and the new digital system must retain a clear audit trail, even with historical data. QA focuses on compliance and system validation through transition processes, QC focuses on real-time quality inspections and product checks in the new system, Document Control focuses on ensuring all documents are correctly migrated and version controlled, and the training department focuses on ensuring that personnel across all impacted departments are trained on new systems before they are rolled out.
