Integrating with document management
Elements Document Management principles
The Process information itself
Elements Process Knowledge is architected as a secure Document Management solution. The Documents just happen to be a set of structured Diagrams, representing process knowledge with a particular format and set of attributes. The hierarchical nature of those Diagrams also creates a particular type of relationship and set of dependencies.
The 3rd party documents that activities in Elements link to
In addition, linking Process Activities to external documents means there is a Document Management requirement on those documents, which Elements does not include. Normally you would manage these externally on a local or cloud based document management system. Elements lends itself very well to integrating with any Document Management solution that allows documents to be launched via a URL. For more detail, scroll down.
So back to the Process Documentation;
To draw a simple analogy, If all your Process Knowledge was in a book.
- The Free capability allows you to decide who can edit the whole book and the individuals (inside and outside your Space) – can view it.
- The Pro capability (Fall 2016) allows you to decide who owns the structure. Who can edit which parts of the book – and manage who can view or edit content down to paragraphs within pages.
- The Governance capability (late Spring 2017) allows you to manage versions of pages within the book, and the release of new editions with whole new chapters and minor edits. It manages the circulation of changes to all stakeholders who need to sign-off. It manages the archives, the reviews, the audit trail and when everything is ready, the publishing, the distribution and the recording of who has signed off as having read and understood it. It will even help them give reviews and feedback so the next edition of the book will be even better.
Document Management within Elements Process Knowledge
So to start to get into the detail we need to look at this in actual functionality terms as well as the practices and challenges we help you overcome with the architecture and embedded capbilities coming online within Elements over the coming year:
Process Knowledge Governance (due late spring 2017), provides governance of all your process knowledge assets;
- full version control
- release and archive management
- authorization cycle workflows (Process Owners and Stakeholders),
- structured and periodic reviews
- full audit trails to regulatory standards
- inherent support for PDCA cycles
- complementary to a broad range of ISO/FDA/FSA/FCA regulatory requirements, including the improved process focus of ISO9000:2015
Process Knowledge Pro (due fall 2016), allows you to:
- define access and edit rights by Diagram within the Map
- manage access and User Groups (provides a major benefit once you have any level of large or complex organisation).
- Synch current regulatory statements and risk frameworks into a nested list structure. Link specific clauses to activities throughout any Map in your Team space to demonstrate compliance, manage risk and provide the visualisation platform to enable anyone connected with your operation to understand how to work in the most effective way, while remaining compliant with appropriate regulatory requirements.
- manage Data Tables at a more granular level (access rights)
- set access rights on Data Table Records associated with activities across a given Map or diagram
- Select groups who can add but not edit
- user groups who can add and edit
- at Data Table and record scope
- at Map or diagram scope level
Process Knowledge (Free), Gives you
- control of the manage, edit and view rights to the Map. i.e. You can limit edit rights down to individual or multiple users as you choose, but they apply to the whole Map.
- You can also decide who gets to see the content at all as you share and set View, Edit or Manage rights down to individual users for a given Map.
- Rights to manage Data Tables across the whole library (Data Table Manager).
- Rights to manage Resources across the whole library (Resources Manager).
Managing Attached (Notes) Documents
Notes are internal documents embedded within activities on Diagrams. Therefore the document management is based on the users with edit rights to the Diagram they are part of.
Managing Data Tables
Data Tables are added, edited and managed in the Elements central tab, under ‘Libraries’, ‘Data Tables’. Once you have a Data Tables setup, you can add a data table to any activity on any Map in the Team space.
Managing Documents through URL links
We do not manage external documents. Todays’ world is one of location and device independent access to information. Elements is a cloud based application for Process Knowledge sharing, which complements the many cloud and on-premise based solutions for general file and document sharing. All you need is URL link access.
Cloud Based Document storage/management : If you have not already implemented an appropriate solution, there are numerous solutions for cloud based storage applicable for the smallest, simplest businesses through to the most highly regulated global enterprises. They provide a wide range of features and capabilities, from free to $7figures.
If not sure, do some searches and research solutions like Google Drive, Dropbox, Microsoft Onedrive etc, through to business/document management focused players like Box, SharePoint, Documentum, M-Files and FileNet) There are literally dozens of very capable solutions for every requirement.
On Premise/Private Cloud storage/management : On premise systems that sit behind a firewall are also fine, as long as you can access the files using a URL. If you can paste the link into a browser and can then access it – you can link it into Elements. Just make sure your intended audience all has view access.Since Elements simply launches those files, there is no additional security or management necessary to ensure the correct access to documents and files.
Highly compliant and regulated environments
There are industries like medical, Pharmaceutical, Food & Drink, Financial Services, specific government sectors, Aerospace & Defence etc, where there are very rigorous document management requirements around procedures, work instructions and policies.
Many companies within these (and similarly regulated) sectors have very strict information security regulations around access to documentation being located behind fire-walled, on-premise systems, with rigorous double or triple authentication measures to access content.
How does Elements, as a cloud solution operate in this space? It’s a question of context and complementary impacts.
Firstly, we take our own information security very seriously. Elements has a highly secure software and operational architecture complying with numerous rigorous standards in the cloud. (see documentation for details).
Secondly, we can add enormous value within the most secure environments by providing context and visibility of process. Sometimes a rigorous structure and a compliance driven set of documentation focused on the clauses of a set of regulations makes it really hard to see how things actually work across an organization. The Elements Process Knowledge approach and capability can put all this great compliant detail into an acessible, useful context which engages people. This can have a major impact on getting people to improve compliance through better understanding and awareness. It can also have a big impact on audits from both auditors and the organization preparing for and being audited.
What strategic benefits and opportunities does Elements Process Knowledge give you in compliant and regulated environments?
Whatever regulation you have to operate within, producing documentation and building a compliant management system can become a major overhead. While every system is intended to add value and support the people who need to operate within it, many Management Systems can become the proverbial ‘tail wagging the dog’.
When the end customer experience, flexibility, innovation and commercial performance suffer due to ‘regulatory constraints’, it is often not the regulations themselves to blame, but the sheer complexity of building a management system to document and comply to the necessarily changed and constrained ways of working.
So how does Elements Process Knowledge, as a cloud solution deliver benefits in this space? It’s a question of context and complementary impacts.
Leverage and enhance your existing compliance and risk systems
First, we take our own information security very seriously, so that you can use it for compliance and risk related related documentation, even though it is based in the cloud. Elements has a highly secure software and operational architecture complying with numerous rigorous cloud security standards. (see documentation for details). If you are a client operating with specific requirements, please contact email@example.com to arrange a 1-1 session on security and architecture.
Second, we can add enormous value to information stored in the most secure environments by providing layer of context and visibility of process, that allows users to navigate to the highly secure supporting documentation to understand or carry out specific activities.
Sometimes a rigorous compliance driven structure of documentation, focused on the clauses of a set of regulations makes it really hard to see how things actually work across an organization. The Elements Process Knowledge approach and capability can put all this detailed documentation into an accessible, useful context which engages people. This can have a major impact on enabling people to continually improve their working practices, while remaining compliant through better understanding and awareness of the impacts of doing or not doing certain things. It can also have a big impact on audits from both auditors and the organization preparing for and being audited.
Once you have a clearer process context, it becomes self evident to focus on what is right for the customer and the orgnizational goals. The organizations’ Common sense can increasingly prevail, with the regulatory constraints much more likely to be surfaced in context and where necessary, challenged.
Time and again over the last 20+ years, we have seen situations where ‘standard practice’ was flawed but accepted because ‘we have to do it that way – it’s a compliance issue’. If you then ask what regulatory requirement is stopping a specific process improvement idea, the answer was surprisingly often: ‘Actually there is no reason we can’t change’. The issue was that the people involved didn’t understand the process implications well enough to ask the right questions and interpret the regulatory requirements in the right context. When faced with an incomplete or confusing picture, the human mind almost always says no. When regulatory compliance is on the line, the lack of context, the lack of a clear picture means that things don’t get changed, decisions don’t get made. People are rightly cautious about making a mistake and causing a compliance issue.
Third, the Process Knowledge product itself contains many specific features (especially in Pro and Governance forms coming soon), that allow you to create and manage the documentation directly in managed Process Knowledge content showing ‘who needs to do what when, why and how’ – to deliver on your organizations objectives (and yet still be compliant).
Think of it as turning the typical documentation in an Operational Management system on it’s head.
Regulatory Centric Management System
Frequently a Management System is:
- structured around the requirements of a given set of regulations
- with high level policy documents
- in parallel (and often related to) a list of procedural documents
- that relate to sets of lower level procedures and work instructions
- that may or may not contain visualisations of process. The process is often contained within paragraphs and bullet point lists in text based documents.
Outcome? A documentation industry inside most orgnizations that is hard to get your head around, engage with, maintain, improve, work to, audit and (most importantly) change. So often people try to limit change because ‘we’re in a regulated industry’. Is this really ‘because of compliance’…or because it’s just so hard to understand what’s going on and how to change it without breaking the management system?e
Process Centric Management System
Whereas it can be:
- Structured around a graphical hierarchy of Process Knowledge
- The high level maps can easily describe the key activities and scope of responsibilities
- The standard Process Knowledge building block already captures ‘who needs to do what, when, and why.
- The structured hierarchy defines scope and context, into which high level policies can be attached
- Procedures can be simplified and shortened, since the Diagrams describe most of the procedural information and structure.
- The lowest level procedures are simply attached to activities
- Lowest level work instructions are either replaced by diagrams or split into the instructions representing a given step – and attached to an activity.
The Process content can then be managed and controlled as a compliant Management System itself, using the following principles and capabilities.
If you have specific questions or requirements around supporting Document Management, Operational Management Systems, Quality Systems or Risk and Compliance – engage with the Partner Directory and the Q&A site. Many of the partners and individuals involved in the Elements ecosystem have a lot of experience and expertise providing support and insights in this area.
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