Escalation of Critical Events

Event management systems need to have an escalation mechanism to ensure critical events are quickly elevated to a senior level to ensure organization-wide timely reactions.

Consistent Event Reporting

There are many reasons for a fast escalation.

  • Events that trigger reporting to Regulatory Agencies (e.g. Serious Breach, Urgent Safety Measures (UK), Field Alerts, Biological Product Deviation, Medical Device Report)
  • Events that require immediate action to prevent additional harm from across the organization
  • Events that require marshalling resources from large parts of the organization

GMP

GCP

GPVP

GLP

Research

IT

         Impact to data integrity

       Impact to product quality/supply

       Impact to data integrity

       Data/privacy breach

       Event impacting on-time compliance rates (not isolated/steady state)

       Impact to data integrity

       Impact to data integrity

       Reference GxP area for Impact resulting from/linked to system error/failure

       Product Quality/ CMC events in accordance with MRB criteria (or other events of similar scope of impact)

       Impact to study integrity

       Impact to subject’s safety, rights or welfare

       Gaps in reporting/ collection of potential AEs

       Impact to study integrity

       Impact to study integrity

       System design, testing, deployment, upgrade, etc. event impacting GxP data integrity or regulatory compliance

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Recurring event with broad scope of impact

       Impact to program milestones & corporate goals

       Impact to program milestones & corporate goals

       Impact to program milestones & corporate goals

       Impact to program milestones & corporate goals

       Impact to program milestones & corporate goals

       Potential Falsified or Counterfeit Product

       Potential Fraud or Misconduct

       Potential Fraud or Misconduct

       Credible Risk of Product Shortage

       Quality event with patient safety risk/gap

       GxP Data Breach

       Potential Product Recall

       Significant Quality Event Notified to Regulatory Authority

       System error or failure with significant GxP compliance impact

·       Potential Critical Finding Resulting from Regulatory Authority Inspection or Audit by External Body/Third Party

·       Quality Event/Observation Classified as Critical (Event or Internal Audit) Notification from Regulatory Authority or other External Authority of Findings of Significant/Critical Quality Deficiency (inspection or other than through inspection)

o   e.g.; Refusal to File, Notification of Inadequate Response to Inspection Findings (e.g.; Other Action Indicated (FDA classification), Warning Letter

 

You can drill down to a lower, more practical level, like this

Escalation Criteria

Examples of Quality Events for Escalation

Potential to adversely affect quality, safety, efficacy, performance or compliance of product (commercial or clinical)

       Contamination (product, raw material, equipment, micro; environmental)

       Product defect/deviation from process parameters or specification (on file with agencies)

       Significant GMP deviations

       Incorrect/deficient labeling

       Product complaints (significant PC, trends in PCs)

       OOS/OOT (e.g., stability)

Product counterfeiting, tampering, theft

       Product counterfeiting, tampering, theft reportable to Health Authority (HA)

       Lost/stolen IMP

       Fraud or misconduct associated with counterfeiting, tampering, theft

       Potential to impact product supply (e.g., removal, correction, recall)

Product shortage likely to disrupt patient care and/or reportable to HA

       Disruption of product supply due to product quality events, natural disasters (business continuity disruption), OOS impact, capacity constraints

Potential to cause patient harm associated with a product quality event

       Urgent Safety Measure, Serious Breach, Significant Product Compliant, Safety Signal that are determined associated with a product quality event

Significant GMP non-compliance/event

       Non-compliance or non-conformance event with potential to impact product performance meeting specification, safety efficacy or regulatory requirements

Regulatory Compliance Event

       Significant (critical, repeat) regulatory inspection findings, lack of commitment adherence

       Notification of directed/for cause inspection

       Notification of HA correspondence indicating potential regulatory action

 

Management Review – a Structured Analysis of Reality

What is Management Review?

ISO9001:2015 states “Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.”

Management review takes inputs of system performance and converts it to outputs that drive improvement.

Just about every standard and guidance aligns with the ISO9001:2015 structure.

The Use of PowerPoint in Management Review

Everyone makes fun of PowerPoint, and yet it is still with us. As a mechanism for formal communication it is the go-to form, and I do not believe that will change anytime soon.

One of the best pieces of research on PowerPoint and management review is Kaplan’s examination of PowerPoint slides used in a manufacturing firm. Kaplan found that generating slides was “embedded in the discursive practices of strategic knowledge production” and made up “part of the epistemic machinery that undergirds the know-ledge production culture.” Further, “the affordances of PowerPoint,” Kaplan pointed out, “enabled the difficult task of collaborating to negotiate meaning in an uncertain environment, creating spaces for discussion, making recombinations possible, [and] allowing for adjustments as ideas evolved”. She concluded that PowerPoint slide decks should be regarded not as merely effective or ineffective reports but rather as an essential part of strategic decision making.

Kaplan’s findings are not isolated, there is a broad wealth of relevant research in the fields of genre and composition studies as well as research on material objects that draw similar conclusions. Powerpoint, as a method of formal communication, can be effective.

Management Review as Formal Communication

Management review is a formal communication and by understanding how these formal communications participate in the fixed and emergent conditions of knowledge work as prescribed, being-composed, and materialized-texts-in-use, we can understand how to better structure our knowledge sharing.

Management review mediates between Work-As-Imagined and Work-As-Done.

As-Prescribed

The quality management reviews have “fixity” and bring a reliable structure to the knowledge-work process by specifying what needs to become known and by when, forming a step-by-step learning process.

As-Being-Composed

Quality management always starts with a plan for activities, but in the process of providing analysis through management review, the organization learns much more about the topic, discovers new ideas, and uncover inconsistencies in our thinking that cause us to step back, refine, and sometimes radically change our plan. By engaging in the writing of these presentations we make the tacit knowledge explicit.

A successful management review imagines the audience who needs the information, asks questions, raises objections, and brings to the presentation a body of experience and a perspective that differs from that of the party line. Management review should be a process of dialogue that draws inferences and constructs relationships between ideas, apply logic to build complex arguments, reformulate ideas, reflects on what is already known, and comes to understand the material in a new way.

As-Materialized

Management review is a textually mediated conversation that enables knowledge integration within and
across groups in, and outside of, the organization. The records of management review are focal points around which users can discuss what they have learned, discover diverse understandings, and depersonalize debate. Management review records drive the process of incorporating the different domain specific
knowledge of various decision makers and experts into some form of systemic group knowledge and applies that knowledge to decision making and action.

Sources

  • Alvesson, M. (2004). Knowledge work and knowledge-intensive firms. Oxford University Press.
  • Bazerman, C. (2003). What is not institutionally visible does not count: The problem of making activity assessable, accountable, and plannable. In C. Bazerman & D. Russell (Eds.), Writing selves/writing societies: Research from activity perspectives (pp. 428–482). WAC Clearinghouse
  • Edmondson, A. C. (2012). Teaming: How organizations learn, innovate, and compete in the knowledge economy. Jossey-Bass
  • Kaplan, S. (2015). Strategy and PowerPoint: An inquiry into the epistemic culture and machinery of strategy making. Organization Science, 22, 320–346.
  • Levitin, D. J. (2014). The organized mind: Thinking straight in the age of information overload. Penguin
  • Mengis, J. (2007). Integrating knowledge through communication: The case of experts and decision makers. In Proceedings of the 2007 International Conference on Organizational Knowledge, Learning, and Capabilities (pp. 699–720). OLKC. Retrieved from https://warwick.ac.uk/fac/soc/wbs/conf/olkc/archive/olkc2/papers/mengis.pdf