Top Ten Requirements to Manage Quality

Posted in PLM, QMS, Quality
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Top 10 RequirementsIn a recent eBook by Tech-Clarity entitled “Does Quality Management Belong in PLM?”, author Jim Brown points out that when companies bandage together disparate siloed product lifecycle management (PLM) and quality management systems (QMS), design processes are compromised and products suffer from serious costly quality errors. 

The eBook makes the point that with an all-in-one product development platform (with embedded Quality capabilities) companies are better able to manage their quality management processes and regulatory requirements.

Brown makes his point quite clearly that embedded quality in PLM allows companies to “develop an accurate, cohesive view of the product and its history, and focus on their core competencies: delivering world-class products, on time and on budget vs battling complex third-party vendor integrations.” 

He goes on to list ten PLM requirements necessary to manage quality: 

1. Effective bill of materials (BOM) management 

2. Ability to manage product-centric data relationships 

3. Strong business process management 

4. Efficient search capabilities 

5. Support for quality processes (CAPA, NCMR, etc.) and product-centric processes (ECR, ECO, etc.) 

6. Collaborative capabilities that create real-time, reusable corporate knowledge 

7. Business intelligence for product and quality data 

8. Granular security model and electronic signatures (21 CFR Part 11) 

9. History of trouble-free validation (if needed) 

10. Ease of use and ease of implementation

Arena’s robust PLM solution checks off on all ten of the aforementioned requirements. No one has a more robust PLM solution than Arena. Arena invented cloud PLM and is the global cloud PLM market leader. While no longer just a PLM solution, Arena offers an all-in-one product development platform with embedded ALM, QMS and so much more. 

But if you specifically want to know how our product development platform has helped innovative companies achieve their quality goals, from others' lips--consider these third-party quotes: 

“Quality drove our PLM implementation. We wanted accurate BOMs and revision history. Then we quickly developed more in-depth quality processes.” 

“We realized that associating quality processes directly to our product data had significant value, so we decided to implement PLM quality tools to improve our Quality Management System. PLM workflows also allow you to provide users with assignments so they can work on the right process steps.” 

— Rafael Leano, Applications Analyst, T.D. Williamson 

“We always had an electronic record, but as soon as quantities picked up we realized spreadsheets weren’t going to work. When more than one person needs to manage the spreadsheet, it starts to break, you get different versions, and two people editing at the same time causes issues.” 

“One of the biggest features is the ability to collaborate internally and with suppliers and partners. PLM allows you to give a supplier visibility or perform a role in the process, like approving a document change or developing a plan of action for an issue.” 

— Derek Warmack, Project Engineer, Yukon Medical 

“A big part of the advantage of managing quality in PLM is linking it to the Bill of Materials. It’s helpful not having one software for Quality and different software for everyone else.” 

“We looked at cost over three years between PLM and other QMS software packages. There was a cost savings for PLM, but the capabilities and the linkage to the BOM led us to PLM even without the cost savings. Since then we’ve improved complaint investigation duration and timeliness of CAPAs through process improvement supported by PLM.” 

— Chris Hill, Director of Quality, Organ Recovery Systems 

If you are a company focused on improving your quality processes, let Arena help you. Discover more about our quality offering by clicking here.  

In short, with Arena’s all-in-one product development platform, all the people, know all the stuff—all the time.

To learn more about how Arena embeds quality into PLM for maximum business results, click here

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About the Author

John Papageorge
John Papageorge has worked at some of the biggest names in the high tech industry, launching products and programs for companies, such as Oracle, HP, Cisco, and Microsoft. John's passion ... Read More 

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