Forget Hamlet. What’s going on? That is the question.

Data collection is about addressing this most important question in strategy. Maybe “What’s going on?” is the greatest question ever asked. Right up there with “Where are we?” and “Who are you?”

“What’s going on?” predicates its corollary, “What should we do?” All strategy boils down to it: what’s going on and then what should we do?

If you have strategic or operational responsibility in a business, “What’s going on?” is your starting point. It cuts to the heart of your need for diagnosis and situational awareness. Strategy is about insight into what’s going on and then making choices and deciding on policies and coherent programs of action based on this understanding. If you don’t know what’s going on, if you have no situational awareness, then policy creation becomes haphazard and action incoherent. If you don’t know what’s going on in detail, then you cannot know exactly what to do. You’re clueless and at the mercy of external influences and chance. 

Data collection is the eyes and ears of the modern business. In a complex environment characterized by many levels of organization, many autonomous external agencies acting independently, many internal agents acting with more autonomy than you think, and the whole system subject to adaptation and constant change, those eyes and ears need to be switched on and working well. 

This article is about the latest techniques in this battle for perception. What tools can you deploy to increase situational awareness and therefore organizational resilience and performance? Data needs to be collected, analyzed and understood before it can be reported as information or used to make policy and decisions. It needs to be fresh: last week’s stale data is last week’s situation. What’s going on today? 

In the context of quality and compliance management, situational awareness and operational integrity requires that data be collected from a variety of sources through various channels. These are the basics:

• CAPA reporting
• Other operational reporting such as safety or incident reporting
• Audit findings
• Data from inspections, samples and surveys
• Data from third-party systems that integrate with the QMS such as the CRM system
• Other tools and systems that support and enable a mature culture of openness, reporting, sharing and learning

TIMELINESS AND INTEGRITY

Data collection is a cornerstone of quality management and, in 2016, the context of quality management is increasingly enterprise risk management (ERM)—particularly for larger organizations. Any discussion of data collection therefore needs to consider risk. 

ISO 9001:2015 emphasizes the risk-based approach to quality management which, in terms of data, means monitoring the status of risk controls in as close to real-time as possible. The channels for control data are still those listed above but with an additional imperative for timeliness so that emerging risks can be spotted. The takeaway here is that a crucial aspect of data collection is timeliness: the mature QMS needs to present what’s going on today. Today. 

We cannot talk about data collection without mentioning integrity. In a pharmaceutical company, for example, the way in which data is managed has a huge impact on the integrity and risk profile of the business. Compliance, safety, stakeholder and public confidence, and ultimately brand and corporate survival, depend on data integrity. And yet, in much the same way as laggards in the oil industry persist in handling safety data in spreadsheets, you might recognize the immature QMS by sloppiness in the collection and handling of data:

• Data stored in paper files, spreadsheets and directories
• Weak processes and cultural factors:
• Lack of clarity or absence of coherent policies and processes for data collection
• Poor configuration, including failure to correctly monitor controls
• Culture does not support openness and reporting
• The processes are good but execution is poor; i.e. frequent errors
• Insufficient supervision and internal control
• Audit trail not available
• Financial and operational pressures create moral hazard that jeopardizes data integrity
• Data can pass casually between systems
• Access to data for analytical purposes is not controlled

ENABLING TECHNOLOGIES

Design the system and then enable it with appropriate technology. In this regard ISO 9001:2015 establishes the correct drivers, above all the establishment of a risk-based model for quality management that is championed at board level and throughout the organization. With this cultural imperative in place, a QMS can be implemented that addresses all the cultural and process risks identified above and that automates data collection, analysis, interpretation and reporting. 

• CAPA and advanced reporting capabilities, including in-app collaboration and chat
• Business transformation though modern reporting processes—flexible, remote and mobile working—enabled by mobile apps and cross platform compatibility so data is collected effectively from the front line
• BI dashboards present the correct level of information to the right people at the right time
• A document management system replaces content management or file storage system
• Integrated asset management collects data relating to equipment
• Vendor management capability collects data from the supply chain
• The ability to integrate via API with third-party systems provides a holistic, real time view of all relevant data
• Data collection is understood throughout the organization as a critical activity on the maturity journey towards basic or full ERM

Business intelligence tools and the ability to analyze data and present it as management information in real time dashboards provide a modern QMS with the ability to raise automatic alerts and workflow-driven escalations when KPI thresholds and risk controls are compromised. It is possible to track trends and keep on top of emerging risks to the business such as correlated customer complaints.

A couple of examples of third party system integration from our customer base include:

• The SAP QN (Quality Notification) feature can be integrated to the QMS such that a QN can enter the system as an incident and then be escalated and managed according to defined workflows. Task closure is ultimately fed back into the SAP QN process.
• CRM system integrated with QMS such that quality issues feed automatically to the incident management module. Again this is closed loop and updates from the QMS are fed back to the CRM so that customer service staff are immediately aware of the latest developments in a situation.

REPORTING AND SITUATIONAL AWARENESS

Technology is an important enabler for a culture of openness, reporting, sharing and learning. Everyone is familiar with ‘sharing’ in social media. The more intuitive and user friendly an application is, the more it will be used; and the more it is used the more effective it becomes. So if you are in the market for a quality management solution, put User Experience at the top of your list of criteria: it could be your critical success factor.

Related to this is the ‘Forms Designer’ or ‘Forms Engine.’ Some old quality management solutions do not let you easily design your own forms for data collection and reporting. Modern solutions have drag and drop forms designers that are friendly and let you create whatever templates you need. The challenge is to rapidly, flexibly and accurately capture and mobilize the business process—for example, incident reporting—so that it is easy for users to submit accurate information. Replacing retrospective paperwork with real time electronic reporting delivers 100% accuracy when the forms are designed in such a way that they cannot be submitted unless the correct process has been followed. In the context of the maturity journey, this is what we mean by ‘business process transformation’ and ‘modernization of working practices.’

Must-have features for reporting in a QMS:

• The option to report with confidentiality
• Mobile reporting including use of native device capabilities such as GPS and camera
• The ability to define fields and forms that accurately reflect the information you need to capture in a particular type of report
• Mandatory fields
• Attach supporting evidence

With a modern, integrated, user friendly QMS in place, a business becomes more mature and develops a culture of accountability. Moreover, it becomes more resilient, adaptable and able to cope with uncertainty, responding swiftly to unexpected incidents and protecting its reputation and brand.

So, what’s going on?

How well can you answer that question? Q