Controlled Document Management (CDM)
Software for Managing Work Instructions, Standards, Procedures, Policies and Controlled Documents for Quality Assurance
Every organization grapples with how to best manage critical documents, be they safety procedures, operating protocols, or manufacturing processes. RKO’s Controlled Document Management (CDM) software provides a controlled method for authoring critical or sensitive documents within a uniquely flexible and compliant solution.
CDM provides you greater governance over your controlled documents without limiting employees’ ability to use them.
Creation & Variances
Using CDM software, the new controlled document request or variance request, takes place through an auditable workflow. A variance request can be triggered by a person, another document’s change, a pre-defined date (documents that need to be reviewed every two years for example), following an incident, when there’s been a regulation change or if a new model of equipment is being used.
This initiation will then trigger a series of subsequent actions including notices to effected parties, content requests to specified parties, approval workflows (no more manual follow-ups!) and, when necessary, stop work orders to the end user of the document.
Reviews & Approvals
Once the document has been updated, many groups often need to approve it. Sometimes the updates & approvals happen concurrently. This is all managed within CDM to ensure notations are in real time, to ensure that the process if fully auditable and to ensure the process doesn’t stall. Auto-reminders and escalations are part of the software ensuring that documents don’t take months or years to update, which can put you at risk of being out of compliance.
Not only can authorized users see where each document is in the process but there are “chat” areas to discuss and collaborate on documents, and a location to put supporting documentation, files, emails, images or even video if needed.
And by consumers – we mean people consuming/using/reading/needing the controlled document.
Consumers will have the necessary documents to do their job safely and within compliance. Documents can be consumed via mobile devices so if it was approved and updated 5 minutes ago – they have the right document in hand. That means no more binder updates or searching through document versions looking for the correct one.
Consumers, when authorized, can also see all linked or related content when searching. For example, if a field worker is searching for the emergency shutdown procedure, they may also see the material safe handling procedure in “related links”.
Modification & Variance Requests
Variance requests can take place on-site when consumers see a discrepancy in their work instructions vs. what is out in the field. The quicker this gets rectified, the less down time there is and productivity increases. It also means fewer errors and a safer environment. The more this process is streamlined, consumers can count on faster turn-around times and are more likely to make the request in the first place – again facilitating fewer errors and a safer environment for all.
Fully Auditable Process
In highly regulated industries, the auditability of the entire document life cycle process is essential. CDM allows, not only the versioning of the document to be auditable, but the collaboration, the process, the request, the triggers, the people and every other element in the process to be accounted for so that you, and the regulatory agency, know you are doing your due diligence.
Common Current Challenges
The main reasons why our clients invest in this solution are:
- They have staff still using outdated policies.
- Authoring of critical documents can be slow and chaotic.
- Review & approval involves a lot of manual management that could be managed with technology.
- They aren’t sure if they could provide a proper audit trail, including emails, if audited.
- Revisions take so long that the document’s expiry date has long past and “consumers” are out of compliance.
- Consumers have a difficult time providing feedback or input – which is essential for trying to overcome ingrained local practices, issues that are not currently documented or on management’s radar and any number of ways consumers provide essential information and data.
- Or, there’s been a compelling event like:
- An injury took place, or environmental impact, when a policy was incorrectly accessed or was inaccessible.
- Significant productivity has been lost from lack of policy adherence or in waiting for a policy to be updated or approved.
- A lawsuit has been filed against the company for being out of compliance.
With NEB doubling its inspections and an increase in public scrutiny, companies can’t afford to “get it wrong”. Regulations have also shifted to make employees liable too – so everyone has a stake in wanting to get it right.
If the length of time to update critical documents and lack of insight & auditability for each document is a concern for you, feel free to contact us via the form below, or watch the following video to see how it works.
I’m a bit surprised at how flexible it is and how much more quickly our documents get updated.”
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Key Groups Effected
Quality Assurance professionals often “own” controlled documents but don’t often have great tools for managing this aside from word & email. The scope and risks have increased significantly over the years and old methods just aren’t effective anymore.
NEB is clearly on a path of “zero incidents” and expect QA professionals to build “continuous improvement” into the system & into the culture. They want to see a clear management system, a way to measure the company’s risk, and performance therein, and is also expects QA to ID emerging issues & opportunities for regulators. CDM is a full bodied system that can address all of these needs – helping QA tackle accountability, communication, deadlines, incident tracking, follow-up mechanisms, cutting-edge search tools (web & internal) and most importantly, a fully auditable trail of each feature to account for the company’s due diligence.
Not only will your legal team appreciate the mitigation of lawsuits, but with storage of key content in an IBM ECM repository, records can be be classified and kept as records for eDiscovery, put on legal hold or disposed of when legally able to.
IT will appreciate that CDM is built with solid & reliable IBM software and provides a content management strategy that includes the disposal of unnecessary content – mitigating email and other content storage costs and related data management costs.
Records Managers will appreciate the proactive declaration & classification of content, especially the often forgotten record – emails. It allows them to complete the compliance & governance cycle and meet regulatory requirements. CDM’s classification system surpasses the norm in terms of quality, access & usability.
The C-suite wants to mitigate law suits to be sure, but they are also concerned about losing government support for new projects if they get known as a repeat offender. Bad PR and fewer projects can have a significant impact on share price, funding for new projects and subsequently profitability.
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