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Chad Kymal


21st-Century Document Management Systems

Future systems start with documentation hierarchies but focus on electronic process documentation

Published: Tuesday, December 3, 2019 - 13:03

With the advent of the internet, cloud, and electronic workflows, what is the future of documented management systems? Do we continue with a structure of quality manual, processes, work instructions, and forms and checklists? How do we imagine the future of documented management systems?

For enterprise and site documentation, there’s a need for all entities, from site to department to individuals, to have their own documented management system structure. The documented management system should be a repository of organizational knowledge, in the form of documentation, records, projects, audits, dashboards, customer and/or interested party needs and expectations, calibration data, and much more. How is this possible?

Furthermore, documented flows should give way to virtual electronic workflows that help implement and sustain an integrated management system.

Documented management systems have vastly evolved during the last 30 years. Commonly used paper documentation in the 1990s became electronically accessed documentation stored in Microsoft Word or Excel documents in shared directories. It then slowly moved to web-based documented management systems via company developed intranet software. This is where most organizations are today. There are organizational documents stored in the internet or intranet. At the same time, there are various repositories of process documentation for the design, R&D, and sales groups. These systems will now need to transition to the next level of change—electronic workflows that digitalize transactions. When this happens, not only will a documented management system provide standardization of process documentation, it also will guide the user in performing the process, measure each transaction, and check the quality of performance as it is being performed.

The key technologies making this possible are web- or cloud-enabled workflows such as performance management, audit management, calibration and measurement system analysis, new product development, and other cloud- or web-enabled processes that help the organization meet its mission-critical quality management systems (QMS) applications. These electronic workflows capture transactions, digitize them, and enable the use of AI to fulfil transactions.

To move to this next stage, some basic understanding of a QMS and other management systems is critical. The idea of an integrated management system and the integration and standardization of processes is very important. Next, top management needs to make the right decisions to take the enterprise into this next level of change. These changes and key decisions will be outlined here.

Documentation structures

Process documentation is typically arranged in four levels. The first involves the process map or the “sequence and interaction” of processes within the organization. The first initial process map explains the enterprise or the relationship of the entities of the organization, i.e., sales, design, corporate, and manufacturing sites. Note that process maps and key organizational information are captured in a document called a quality manual or BMS manual.

Next, the enterprise process map is subdivided into entity process maps as show in figure 1, or into the process flows of the organization. There are two types of flows: ones that connect up the entities, and others that are within an entity. Processes, by definition, are high level. They flow between the functions of an organization or between entities of the enterprise.

Figure 1: Linked process maps

The flows are further subdivided into work instruction flows that explain how a particular process step is performed. Although processes cut across organizations or functions, work instructions are departmental-specific or job-specific. They explain how a particular process step is performed. Note that although this understanding of work instructions provides insight into their role, in reality work instructions are operator instructions and setup instructions explaining how to run a machine or set one up on the shop floor.

The last documentation level is the need to capture information as a process or work instructions is being transacted. This information is captured via forms or checklists. When these forms and checklists become information, that leads to the digitization of information in a process. See figure 2 on the subdivision of the process map into forms and checklists.

Figure 2: Subdivisions of processes in an enterprise

Integrated management systems

An integrated management system (IMS) helps an organization implement more than one management system. Typically, organizations will integrate ISO 9001 and related QMS standards, such as ISO 14001 for environmental management systems (EMSs) and ISO 45001 for occupational health and safety (OHS) into one integrated management system. In other words, one set of organizational processes, as shown in figure 2, will satisfy or conform to the requirements of the QMS, EMS, and OHS standards. Omnex explains that IMS have integrated processes, integrated risk, and integrated audits. (See figure 3.)

Figure 3: Three pillars of integrated management systems

Typically, organizations have standalone management systems for QMS, EMS, and OHS. This is a lack of integration. Furthermore, each site of the organization will have its own management system. This is a lack of standardization. An IMS integrates and standardizes all processes in the organization. Why implement an IMS? Simply said, it saves money in implementing and maintaining management systems. (See figures 4A and 4B.)

Figure 4A: Lack of integration and standardization of management systems in an enterprise

Figure 4B: Integration and standardization

Implementing an IMS is a key decision of top management. It enforces standardized processes globally. It does not come easily, however, because it requires organizational change and adoption of common processes.

Best-in-class IMS

Today, Omnex defines best in class IMS as those that conform to QMS, EMS, OHS, social responsibility, and IT security. The first three are something we have been recommending since 2006. Social responsibility was added because most organizations have adapted a code of conducts and guidelines. For many organizations it has remained a code or guideline without implementation. Integrating it with QMS, EMS, and OHS will allow these guidelines to be implanted seamlessly into the organization’s processes. Lastly, IT security, which includes cybersecurity, is an important need in all organizations today due to the high number of security incidents, hacks, and information breaches.

Omnex recommends that a common set of processes of an enterprise work together to provide conformance to the requirements of QMS, EMS, OHS, social responsibility, and IT security. Note that we are not implying that other guidelines, codes, customer requirements, and standards cannot be integrated into the processes of an organization.

Electronic workflows

When implementing an IMS, an organization can implement electronic workflows to enforce integration and standardization globally. Electronic workflows transact processes electronically and help implement and transact processes within an entity or between entities. Electronic workflows must be flexible to transact multiple management systems such as QMS, EMS, or OHS. Additionally, they must have routing capabilities to send transactions to anyone in the enterprise.
A more complete set of characteristics include:
• Enterprisewide web- or cloud-enabled system
• Manage the enterprise, from one site to multiple sites
• Support multiple languages and multiple date conventions
• Integrate with email notifications, reminders, and escalation, and route transactions inside or outside the enterprise
• Integration with legacy and enterprise resource planning/product lifecycle management systems
• One-point user authentication
• Role-based security
• Fully integrated solution, lead data entry
• Enterprise integrated processes
• Conformity to ISO 9001, ISO 14001, ISO 45001, ISO 26000 (social responsibility), and ISO 27001 (IT security)
• Ability to add one site and then scale up to the entire enterprise

Typical electronic workflows can include:
• Risk and opportunity management
• Sales and contract review
• Product, process, and service risk
• Training, competency, and benefits
• Audit management
• Documented information management
• Performance management
(Source: Integrated Management Systems: QMS, EMS, OHSMS, FSMS, including Aerospace, Service, Semiconductor/Electronics, Automotive and Food, by Chad Kymal, Gregory Gruska, and Dan Reid (ASQ Quality Press, 2015)

In the upcoming revision of ISO 10013—“Quality management systems—Guidelines for documented information,” electronic workflows make an appearance as follows:

“Automated workflows are processes that can manage and control the flow of activities in a defined sequence of tasks with predetermined human intervention. When executing the activity, context-specific, drop-down menus or pop-ups can guide the user in completing the transaction. Automated workflows may enhance process consistency (i.e., mistake-proofing) and performance through the workflow design, and can result in automated decision making through analysis of data in interrelated areas.”

These workflows provide information and transact actions via forms and checklists. When the information or transactions are electronic data, then digitization can take place.

Digitization and AI

Digitization is described in the Oxford English Dictionary as: “The conversion of text, pictures, or sound into a digital form that can be processed by a computer.” Transacting processes electronically and performing tasks digitally will support an organization’s digital transformation. Process measurables are typically cost and time, which can be measured transparently as the process is performed. It also allows AI-enabled processes that promise the use of deep learning to help guide decision making. Electronic workflows and digitization with the support of AI will remove drudgery from work processes.

In time, inspection of documents, products, and evaluations will take place via AI-enabled workflows from receiving inspection, examining documents for new product, to final inspection.

Future of documented management systems

The future of documented management systems starts with documentation hierarchies but focuses on process documentation and repositories all in one place in the organization. The documented management system should be a repository of organizational knowledge, in the form of documentation, records, projects, audits, dashboards, customer and/or interested party needs and expectations, calibration data, and much more.

In the documentation list in figure 5, taken from Omnex’s EwQIMS software, each individual or group of individuals can set their own view of the enterprise documentation. The Integrated Automotive QMS menu shows the automotive documentation; the Functional Safety Product Development menu shows the functional safety documentation system; and the Integrated IATF and Functional Safety menu shows the integrated automotive and functional safety documentation. Figure 5 also shows that the electronic workflow for advanced product quality planning (APQP) and production part approval process (PPAP) and New Product Introduction project plans will be found in the same menu along with their respective project dashboards. The supplier project plans are also in the same folder titled “DIA,” for distributed interface agreements. This menu includes repositories for electronic workflows for auditing (Audit Pro), training and competency (HR Pro), inspection data (Inspection Control) and problem solving (Problem Solver).

Figure 5: Documentation list from EwQIMS software

The documentation folder for each department and individual should allow a customized view. This must have the functionality and versatility of a documented management system. Keep in mind the primary purpose of the documented management system is communicating organizational work standards. It has also a secondary role of standardizing and enforcing standards via electronic workflows.

The key point to keep in mind is the need to design process documentation from the enterprise all the way to the work instruction process. Information should be captured digitally to provide and process data for the organization. It is also important to integrate this into machine learning and deep learning (AI) to allow for assisted or automated decision making. Electronic workflows, whether new product development, auditing, or problem solving, must satisfy all the requirements of QMS, EMS, OHS, social responsibility, and IT security.

We have slowly moved from paper documentation to electronic documentation and storage. This change included the change to electronic workflows. The advent of the internet, cloud, and electronic workflows has opened up new possibilities for how documentation should be managed. However, creating electronic documentation is not an easy task. It requires management’s understanding and determination to make this transition. Changing documentation and processes will lead to “real” change and could face resistance from many in the organization. A strong leader and cross-functional team are necessary for success.

To learn more, please join Omnex and Quality Digest for the one-hour webinar, “21st Century Document Management Systems,” Dec. 5, 2019, at 11 a.m. Pacific, 2 p.m. Eastern. Click here to register.


About The Author

Chad Kymal’s picture

Chad Kymal

Chad Kymal is the CTO and founder of Omnex Inc., an international consulting and training organization headquartered in the United States. He is also president of Omnex Systems, a software provider of ISO 9001, ISO 14001, and ISO 27001 management systems. He developed and teaches auditor training for ISO 9001, IATF 16949, ISO 14001, and ISO 45001, as well as an Integrated Management Systems Lead Auditor training course where all three standards are combined in a single audit.

Kymal is also on the ISO/TC 176, ISO/TC 207, and PC283 committees for ISO 9001:2015 (quality), ISO 14001:2015 (environmental), and ISO 45001 (health and safety) management system development.




21st-Century Document Management Systems

Hi Chad.

The ISO Task Force commissioned us to revise the Integrated Use of Management System Standards handbook and published in November 2018, captured many of the aspects you raised. "https://www.iso.org/publication/PUB100435.html"

For Fig B, we had over 100 international case studies that had Cases in Point that had their 'Management System' called that with only a few calling it an Intergated Mgt System. Many were electronic and showed in the Handbook as One Page.

The usual Document Hierarchy was Business Policy Manual (with quality, envioronment, OH&S for the most part) and others (like ISO 27001, 50001, 55001 etc) if the cases demonstraed to us.

As Annex SL and now Annex L, clause state in clause "5.1 .....integrate XXX requiremens into the organizations business process" and hence the IUMSS Cases in Point documentation, electronic, soft or in the cloud or hard copy, were to support the procedures for respective processes under the consolidated 'Policies' in the Business Policy Manual, Business Operating System etc.

Since the use of ERP's, and other electronic documentation software as you mentioned, including OMNEX's. it should be easier for organizations to integrate ISO and non-ISO management system requirements within their processes.

We had no ISO IUMSS Cases in Point with their 'policy manuls' / 'IMS Manuals' documented by the ISO Annex SL "High Level Structure". 

Thank you for your article - just caught up with it.

See you at the next ISO TC176 SC1,2, or 3 meeting in 2020.