EU Annex 21 Published in Draft

On 20 March the new Annex 21 to the EU-GMP Guidelines was published as a draft. The document is entitled “Importation of medicinal Products”. The “Concept Paper” was published on 13 May 2015 (EMA/238299/2015) and the consultation phase ended in August 2015. The first draft for regulatory consultation was published in November 2016. Since then, no further activities or versions have been issued.

The Guidance is aimed at Manufacturing and Importation Authorisation holders (MIA holders) who import human or veterinary medicinal products from third countries. It does not cover products that do not have a marketing authorisation in the EU/EEA and are directly re-exported. The following points are to be regulated by the new Annex:

Physical transfer from the third country to the EU/EEA
Certification by the Qualified Person (QP) (link with the requirements of Annex 16)
Requirements for equipment and facilities
Required documentation
GMP requirements for manufacturers and exporters in third countries
Qualification and audits under the responsibility of the importing company and the Qualified Person (QP)
Import testing
Contractual regulations between all companies or persons involved in the import

Not much new here, but folks should be aware.

Pandemics and the failure to think systematically

As it turns out, the reality-based, science-friendly communities and information sources many of us depend on also largely failed. We had time to prepare for this pandemic at the state, local, and household level, even if the government was terribly lagging, but we squandered it because of widespread asystemic thinking: the inability to think about complex systems and their dynamics. We faltered because of our failure to consider risk in its full context, especially when dealing with coupled risk—when multiple things can go wrong together. We were hampered by our inability to think about second- and third-order effects and by our susceptibility to scientism—the false comfort of assuming that numbers and percentages give us a solid empirical basis. We failed to understand that complex systems defy simplistic reductionism.
Zeynep Tufekci, “What Really Doomed Americas Coronovirus Response” published 24-Mar-2020 in the Atlantic

On point analysis. Hits many of the themes of this blog, including system thinking, complexity and risk and makes some excellent points that all of us in quality should be thinking deeply upon.

COVID-19 is not a black swan. Pandemics like this have been well predicted. This event is a different set of failures, that on a hopefully smaller scale most of us are unfortunately familiar with in our organizations.

I certainly didn’t break out of the mainstream narrative. I traveled in February, went to a conference and then held a small event on the 29th.

The article stresses the importance of considering the trade-offs between resilience, efficiency, and redundancy within the system, and how the second- and third-order impacts can reverberate. It’s well worth reading for the analysis of the growth of COVID-19, and more importantly our reaction to it, from a systems perspective.

Now is a good time to be active in a professional organization

Many of us are wondering just how we are going to get through the next few months of self-isolation. I’d like to recommend getting active in a professional organization.

Amazingly enough this can be a good time to strengthen your network, further your career or maybe even build some friendships. Professional organizations can enhance your personal and professional development and provide endless networking opportunities. Look around your community—there are bound to be a plethora of organizations (from small local start-ups to national chapters) for you to join.

A professional association can your professional home. It is the place where people in the same field will come to know you, support you, and nurture your growth and development. Especially now for those of us who are self-isolating, our professional associations can mitigate the potential isolation and loneliness of our work. There’s nothing quite like sharing in the excitement of learning about new understandings and techniques with others who share the challenges and the joys of the profession. There’s nothing quite as supportive as a group of people who have “been there and done that”. There is nothing quite like sharing your own experiences and hard-won lessons.

Like I said above, there are a lot of professional associations out there. I belong to a plethora of industry (PDA, RAPS), subject area (ACMP, PPA) and domain (ASQ). Right now my heart is certainly fully committed to the ASQ and the Team and Workplace Excellence Forum, but you do you and find the organizations that work for you. But if you need help navigating the ASQ, or are looking for opportunities to get involved, let me know.

So what can you be doing right now to leverage a professional organization? Especially right now? I think there are four major areas to look at:

Colleagueship: Associations are the primary way that people do face-time networking with people who share our professional interests. Most organizations are offering a lot of online options to make it possible to network with people all over the world. Get your face out there and build those connections. And when we can all get together again, keep at it.

Education: We’re in a rapidly changing field. It can take years for good research to make it into print. Now is a great time to catch up and then stay up to date and knowledgeable about new trends in the field. Take an online course. Ask questions.

Information: Association journals, bulletins and newsletters, websites and mailing lists are often the first place that new developments in the field are published. Many associations use their media to alert their members to more than research. Articles and news items also inform us about changes in governmental policies, new trends and other issues that impact the field.

Career Development: Engage in education offerings. Now is a good time to work on that certification. Eventually there will be opportunities again to attend conferences and present a poster or workshop, but right now heavily use the forums and other tools to get that experience of sharing your work and develop your credentials. Further, associations often have listings of job opportunities that are only available to members.

Above all, Stay Inspired and Stay Motivated. Love what you do! It is important to be proactive about things you discover on the journey. Get out there, post, ask questions, answer questions, read and then share what you are reading.

In the routine of remote working you are building, now is a great time to make a habit of blocking off a little time in your calendar to go online and contribute. For fellow ASQ members I hope to see you at my.ASQ.

Procedure Lifecycle

We write and use procedures to help the user complete the task successfully and avoid undesired outcomes. Well-written procedures are an integral part of any organization for operation, managing risks, and continuous improvement. Effective procedures are important for the transfer of knowledge from the engineers/architects of the system to the users of the system.

Good procedures, and we are not talking format so this can be paper documents to a mixed reality guide, provide these four categories of information:

Goal: The goal presented to the user as a state to be realized. This can be an end state or an intermediate state of the overall system.
Prerequisites: The condition for moving toward the desired state or goal. These are the conditions that must be satisfied so that the user can achieve the goal.
Actions and reactions: These states are reached through actions of the user and the reactions of the system. They may have milestones or sub-goals. It involves the description of (a series of) action steps.
Unwanted: These are the states to be avoided (e.g., errors, malfunctions, injuries). It provides guidelines on what to avoid for successful and safe execution of procedure and may include warning, caution, or instruction for solving a potential problem.

Procedures have a lifecycle through which they are developed, administered, used, reviewed, and updated. In the post “Document Management” I discussed the document management lifecycle.

I want to focus specifically on procedures by covering five distinct phases: procedure plan, design and development, procedure authorization, procedure administration, procedure implementation and use, and procedure review and maintenance.

Outlines the 5 phases of a procedure lifecycle — Lifecycle of a procedure

Phase	Includes	Document Management Steps
Procedure plan, design and development	Identifying whether a procedure is necessary; collecting required information; producing instructions and information on the work, regulatory compliance, process and personnel safety; a walkthrough to ensure quality and potential compliance of the procedure	“New SOP is needed” Drafting
Procedure Authorization	Procedure review; publishing the final document; revision control; the approval process.	Review Approval
Procedure Administration	Managing procedure repository, control, and deployment; identifying administers how, when, and to whom procedures are to be delivered.
Procedure Implementation and Use	Procedure is used in operations
Procedure review and maintenance	Periodic review of documents, as well as updates from the CAPA and Change Management processes	Periodic Review

References

Procedure Professionals Association (PPA), 2016. Procedure Process Description. (PPA AP-907-001)
Van der Meij, H., Gellevij, M., 2004. The four components of a procedure. IEEE Trans. Prof. Commun. 47 (1), 5–14

Identifying Waste in Risk Management

Risk Management often devolves into a check-the-box, non-valued activity in an organization. While many organizations ensure they have the right processes in place, they still end up not protecting themselves against risk effectively. A lot of our organizations struggle to understand risk and apply this mindset in productive ways.

As quality professionals we should be applying the same improvement tools to our risk management processes as we do anything else.

To improve a process, we first need to understand the value from the process. Risk management is the identification, evaluation, and prioritization of risks (defined in ISO 31000 as the effect of uncertainty on objectives) followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.

Risk management then is an application of decision quality to reduce uncertainty on objectives. We can represent the process this way:

The risk evaluation is the step where the knowledge base is evaluated, and a summary judgment is reached on the risks and uncertainties involved in the case under investigation. This evaluation must take the values of the decision-makers into account and a careful understanding has to be had on just what the practical burden of proof is in the particular decision.

Does Risk Management then create value for those perceived by the stakeholders? Can we apply a value stream approach and look to reduce wastes? Some common ones include:

Waste in Risk Management	Example	Reflects
Defective Information	“The things that hurts you is never in a risk matrix” “You have to deliver a risk matrix, but how you got there doesn’t matter”	Missing stakeholder viewpoints, poor Risk Management process, lack of considering multiple sources of uncertainty, poor input data, lack of sharing information
Overproduction	“if it is just a checklist sitting somewhere, then people don’t use it, and it becomes a wasted effort”	Missing standardization, serial processing and creation of similar documents, reports are not used after creation
Stockpiling Information	“we’re uncertain what are the effect of the risk as this early stage, I think it would make more sense to do after”	Documented risk lay around unutilized during a project, change or operations
Unnecessary movement of people	“It can be time consuming walking around to get information about risk”	Lack of documentation, risks only retrievable by going around asking employees
Rework	“Time spend in risk identification is always little in the beginning of a project because everybody wants to start and then do the first part as quickly as possible.”	Low quality initial work, ‘tick the-box’ risk management
Information rot	“Risk reports are always out of date”	The documents were supposed to be updated and re-evaluated, but was not, thus becoming partially obsolete over time

Common wastes in Risk Management

Once we understand waste in risk management we can identify when it happens and engage in improvement activities. We should do this based on the principles of decision quality and very aware of the role uncertainty applies.

References

Anjum, Rani Lill, and Elena Rocca. “From Ideal to Real Risk: Philosophy of Causation Meets Risk Analysis.” Risk Analysis, vol. 39, no. 3, 19 Sept. 2018, pp. 729–740, 10.1111/risa.13187.
Hansson, Sven Ove, and Terje Aven. “Is Risk Analysis Scientific?” Risk Analysis, vol. 34, no. 7, 11 June 2014, pp. 1173–1183, 10.1111/risa.12230
Walker, Warren E., et al. “Deep Uncertainty.” Encyclopedia of Operations Research and Management Science, 2013, pp. 395–402, 10.1007/978-1-4419-1153-7_1140
Willumsen, Pelle, et al. “Value Creation through Project Risk Management.” International Journal of Project Management, Feb. 2019, 10.1016/j.ijproman.2019.01.007