Cloud Control for Quality Management Systems

By Greg Milliken

The efficiency and productivity of all businesses are dependent on team members consistently and repeatedly executing important business processes, as well as always having access to the latest and most up-to-date information, such as the correct versions of important documents. However, access to the right information and correct documents is particularly critical in certain industries, especially when compliance with industry and quality standards is involved, such as ISO 9001 related to Quality Management Systems (QMS), commonly employed in manufacturing organizations.

Quality management systems utilized to help achieve ISO certification encompass the notion of Good Manufacturing Practices (GMP), or more broadly, “Good Practice” quality guidelines (GxP) that emphasize records of events, secure access permissions, and standard operating procedures and processes (SOPs), rather than just managing documents or files. This includes ensuring that outdated file versions are managed appropriately, that correct forms and templates are used, and that documents follow mandatory review policies.  

Other important aspects of a comprehensive QMS include capturing and recording signatures at the necessary time, as well as making sure personnel get the right training, read required documentation and have clear to-do lists for important tasks. In addition, an effective QMS ensures that team members only do and see what their authorization allows, and that timed activities actually take place on time. Lastly, the ability to corroborate that these tasks have been completed is a fundamental requirement.

Manufacturing, design and engineering present particular challenges: Not only can there be specific quality management standards in play, but the nature of the work and related documentation can lead to errors quickly propagating to related parts and assemblies, as well as to expensive tooling necessary for manufacture. Changes to a detailed CAD file can be hard to spot, often consisting of merely a slight change in a dimension or tolerance value.

The problem only increases as teams increase in size and become distributed with the addition of external contractors and suppliers, resulting in the risk of greater financial losses, lower quality--and worse, a design failing in use. This results in downtime, and possibly damage to other equipment or injury to employees or customers.

Simply stated, manufacturing, design and engineering environments require that team members are always working on the most current and accurate project files and documentation, including, but not limited to CAD files, to eliminate errors and improve quality and efficiency. The result is a more profitable business that produces high-quality products according to processes and procedures that comply with industry standards.

Seeking Solutions
According to the Association for Information and Image Management (AIIM), professionals can spend up to 50% of their time looking for the right information. And professionals in manufacturing and engineering are no exception; engineers and designers often spend an inordinate amount of time tracking down the current version of a CAD file or other project-related document, which may reside on an individual workstation, or lie buried somewhere within the internal network in a home-grown, and often chaotic, folder structure.

It’s not uncommon for subsequent design changes to be made to the wrong version of a document or CAD file, resulting in significant additional rework when and if the problem is finally identified. If the error is not caught before manufacture, the result is often wasted material and scrapped parts, or low-quality products making it out the door to customers.

This isn’t a new revelation. Manufacturing and engineering businesses have been trying to solve this problem for years, and numerous specialized solutions exist. All of the large CAD vendors have their own product lifecycle management (PLM) or product data management (PDM) solutions (naturally, focused on their particular CAD system), and there are numerous independent vendors offering solutions as well. Most of these solutions are traditional on-premise systems for managing product-related files like CAD files, bills of material (BOMs), process plans, and so on.   On-premise solutions such as this require the purchase, configuration and maintenance of internal servers, and the solutions themselves are traditionally expensive and often complex, requiring sophisticated IT resources to install, configure and maintain them. Further, CAD-centric solutions that are implemented on the engineering side of the house can create information silos that hinder data flow across an organization to other groups such as accounting, marketing and sales.

But with the emergence of the cloud, new options have become available that offer businesses flexibility in terms of how and what they pay for such solutions, the need for IT resources, and data access across the organization and with external partners and customers.

Cloud Benefits
The cloud makes it possible for essentially any business to deploy a document/data management system to alleviate the common problems of misplaced documents and lack of version control, and to facilitate the implementation of a comprehensive QMS.

Cloud-based document management systems provide design engineers and other team members with a framework for centrally organizing, managing and tracking the important documents, information and processes typical in manufacturing firms. In addition, moving to the cloud can often better support lean manufacturing practices and quality management programs to ensure efficient and ISO-compliant manufacturing processes.

In addition to ensuring that documents are centrally organized, tracked and easily located, and proper versions of files are being accessed and edited, cloud-based document management also provides a number of other benefits:

• Convenient online access to all company documents from any location. Cloud access makes sense for today’s notebook- and mobile device-equipped engineers who can retrieve any document from home, while waiting for a flight, or while in a meeting at a client’s office. Similarly, organizations with multiple office locations can now share data from a single repository, rather than separate, unrelated systems such as an internal network, FTP site, or web file sharing service.
• Freedom from the responsibilities of server ownership and management. Running servers requires the tasks of monitoring, maintenance and administration, as well as expert troubleshooting when a server goes down. Manufacturers that leverage cloud solutions are liberated from not only the initial costs of buying dedicated hardware and software, but also all the sometimes-unpredictable costs of ownership.
• Reliability because an increasing number of cloud vendors store data in modern, well-designed data centers with large numbers of servers and multiple levels of redundancy, such that when a server goes down, another is always available to take its place.
• Better protection against data loss. Notebooks can be lost; hard drives can fail; servers can crash. Having information in the cloud secures manufacturers against accidents that can occur to physical devices. Cloud service providers also typically provide automated regular backups of your data, often with storage and archival in a safe, secondary different location.
• More control over information access. Multiple firewalls protect against unwanted access from the outside, while document management permissions can place controls on specified files or document types based on password-protected user accounts and groups. Multiple levels of access can be implemented--read-only, edit, delete, etc.--enforcing security and privacy of sensitive material.
• Scalability. If more storage capacity is required, one simply pays the provider incrementally more, rather than having to purchase an additional server. Conversely, if work is cut back and fewer seats are needed, the monthly fee goes down.
• Operating expenses vs. capital expenses. Cloud storage and service subscriptions are classified as operating expenses for budget purposes, while in-house servers and software licenses are considered capital assets--which depreciate, generate tax implications and eventually require replacement. Manufacturers utilizing cloud-based services pay for these new IT services much like they do utility bills. This accounting re-categorization allows them to utilize their capital budget for other projects.

Not only do cloud solutions represent a significant shift in how businesses store and access their digital content, but also how they pay for it. In a software-as-a-service (SaaS), or cloud subscription model, all expenses for storage, management, maintenance and support are typically included in a single monthly fee. In effect, the subscriber leases access to the application and data storage space as opposed to owning the software and the in-house hardware necessary to deploy and maintain it.

The cloud offers engineers the benefits of online storage, file sharing and document control without large initial outlays for hardware and licenses associated with on-premise installations. Similarly, cloud-based services typically take up less ongoing IT and operational resources because the cloud service provider takes over the responsibility of operating servers, backing up data and upgrading the technology.

With cloud-based document and quality management, engineering firms can control and regulate business processes and file access, control visibility and manage revisions across multiple departments, protect themselves against data loss and securities breaches, and provide the necessary level of automated communication to those people who are affected by changes. Furthermore, all of these benefits can be realized while eliminating upfront system costs and associated hardware resources.

From this perspective, it’s easy to see why cloud-based document management is becoming more and more common among manufacturers today.

Greg Milliken is president of M-Files Inc., the developer of M-Files professional document management software and the cloud-based document management service M-Files Cloud Vault. Contact him via [email protected].

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