Being a Quality Salesperson

A core function of quality leadership is building the case of quality and raising the level of awareness and adoption through the organization. As we work to mature our quality system we build commitment. This is the salesperson aspect of our role where we go out and sell quality and the improvements we are advocating for.

Understand what the customer is buying

You first need to understand what the customer is buying. A person selling a food processor is really selling the ability to easily make tasty food. A person selling a car is selling a whole lot of cultural assumptions about mobility, and power, and the dream of success. Similarly, our stakeholders are not buying specific quality methodologies and tools (e.g. process management, knowledge management, risk management), they are buying something wider, which quality methodologies can deliver to them, and you need to understand what that is. Two of the more wider things that the customer wants that quality usually promises are protection and opportunity.

Quality at heart offers protection against deficiencies and risks. Quality protects against loss of capability.

Quality is also an opportunity – gaining more value from our resources.

Segmenting your audience

Every salesperson needs to know their market and their customer base which we can think of in terms of three market segments:

  • Those who ‘get’ the quality improvement and become immediately enthused, moving rapidly from first contact to positive perception and trial. These are your allies, supporters, and early adopters.
  • The folks who just do not care about maturing quality. They will engage with quality if they must, if it is part of the job, or if everyone ese is doing it. If the improvement is voluntary, or unusual, they will not bother. Moving them to the trial phase of buy-in will require a range of influencing tactics.
  •  Those who do not like quality, seeing it as a threat to their way of working, or even as a personal threat. These people will resist everything unless it is embedded into the very structure of the organization. They can be exceedingly difficult to move to the positive perception state, let alone higher than that. Here your primary tools are peer pressure, social proof, appeals to authority and compulsion.

Think through the types of quality initiatives you are working on. Those that are voluntary will only reach the first third, and that is the best place to start. Or you need more inescapable methods. I usually find for any set of improvements it is a mixture of experiment with early adopters, build social proof and introduce a few critical compulsions.

Influencing Tactics

In their book Mind Gym Sebastian Bailey and Octavius Black outlined nine influencing tactics you can select from, based on the character and situation of the ‘buyer’.

To add context to these, I am going to provide an example of implementing Gemba Walks for leaders, managers, and floor level employees, with standard work that emphasizes pushing to a learning culture.

TacticIncludesExample
ReasoningUsing logical argument to make a case. Reasoning is necessary to support your case with all stakeholder, even if other influencing techniques will create the closing sell. You need to create a compelling logical case for quality improvement, and it needs to be a case for the individual was well as the company.Presenting  case studies and evidence on how this is successful.
InspiringAppealing to emotions and creating the vision. Inspiring people generates an emotional commitment to the vision. Being inspiring demands conviction, energy and passion but is especially effective with the early adopters.A vision of a gemba walk being the hallmark of quality culture and building a culture of inclusivity.
Asking questionsLeading the other person to make their own discovery of the value of the quality improvement.Drawing out examples of an individuals own experience of the value of observation and good coaching.
Ingratiating(Be a buddy)Your stakeholder will almost feel positive toward someone who makes them feel good about themselves.   This is not a great approach for people more senior than you, it comes across as sucking up. You also need to be sincere – people always detect insincerity.Friends helping friends get things done
Deal makingWhen you give another person something in return for their agreement with you. Your ability to use this approach depends very much on your confidence and ability to offer something in return. To keep trust, make sure you deliver on any promises made.Through introducing the Gemba walk we will see a reduction of human error deviations and we will be able to close minor deviations in three days.
Favor askingSimply asking for something because you want or need it. This works well only when the other person cares about you or their relationship with you. If used sparingly, it is hard to resist, but be prepared to pay back that favor!If you can support the Gemba Walk, then we will be able to free up the time for that important project of yours as a result.
Using silent allies (aka social proof)Using the fact that others are getting value from the quality improvement as an argument in its favor. Social proof is sharing the stories of people as like your ‘buyer’ as possible. This really gets to that big middle of uncertain individuals.   Each success, no matter how small, is an opportunity to gather social proof. Hold lessons learned, don’t be afraid to capture good feedback on video!Listen to Nancy here as she discusses how much Gemba Walks have changed the work in her team.
Invoking authorityAppealing to a rule is one you use late in the roll-out program to convince the laggards once the quality improvement has become a clear expectation.Your boss tells you to do Gemba Walks and enforces them happening (report a metric of how many Gemba Walks)
Forcing (“do it or else”)Bringing senior management in to demonstrate clear requirements with clear ramifications that can include temporary or permanent removal of the individual. This is a tactic of last resort.Do this or else
Influence Tactics
Influencing Tactics per Implementation Phase

Be prepared to spend a lot of time in “Yes…but…and” territory, especially in the Strategy Phase.

Warning Letter for Aurolife demonstrates failures in process validation

The FDA commented in a Warning Letter to Aurolife Pharma that the manufacturer lacked data showing that the process was in “state of control” before batch release. The 483 pointed to the FDA’s guidance document Process Validation: General Principles and Practices, and found the company lacks a state of control of the process, which comes back to change control.

They also found major deficiencies in their OOS and cleaning programs.

2020 FDA 483s around change

The yearly database of 483s has been updated by the FDA. Lots will be written on themes as we end the year, so I decided to give a few of my immediate observations.

I find that over time what I focus in on changes, as my jobs evolve and change, and the interests I have shift. However, some things never change, so let us talk change.

Reference NumberShort DescriptionLong Description2020 Frequency2019 Frequency2018 Frequency
21 CFR 211.100(a)Changes to Procedures Not Reviewed, ApprovedChanges to written procedures are  not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, ***8139
21 CFR 211.160(a)Lab controls established, including changesThe establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, ***41817
21 CFR 212.20(c)Adverse effects of changes madeYou did not demonstrate that any change does not adversely affect the [identity] [strength] [quality] [purity] of your PET drug. Specifically,***111
483s related to changes

I think its fair to say the decreases as a result of the pandemic and the reduced inspections.

Over on the device side of things we see:

Reference NumberShort DescriptionLong DescriptionFrequency
21 CFR 820.30(i)Design changes – Lack of or Inadequate ProceduresProcedures for design change have not been [adequately] established.  Specifically,***26
21 CFR 820.40(b)Document change records, maintained.Records of changes to documents were not [adequately] maintained.  Specifically, ***6
21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established.  Specifically, *** 5
21 CFR 820.75(c)Process changes – review, evaluation and revalidationA validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, ***5
21 CFR 820.40(b)Change records, contentRecords of changes did not include [a description of the change] [identification of the affected documents] [the signature of the approving official(s)] [the approval date] [when the change became effective].  Specifically, ***



3
21 CFR 820.50(b)Supplier notification of changesThere is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service.  Specifically, ***3
21 CFR 820.75(c)Documentation – review in response to changes or deviationsThere is no documentation of the [review and evaluation of a process] [revalidation of a process] performed in response to changes or process deviations.  Specifically, ***1
Device 473s around change

I’m a firm believer that pharma should always pay attention to the medical device side for 483s. A lot of us are combination products now (or will be) and there is always good trends to be aware of.

My key takeaways:

  1. Think change management and not just change control and document control
  2. Computer change controls need to be holistic and system orientated
  3. Have a process that ensures changes are appropriately reviewed and approved
  4. Risk based and evaluate validation
  5. A robust supplier management program is critical, plan for change

Here’s a more detailed checklist to help you evaluate your change system.

Rocky Road to ICH Q12 Implementation

Prior to the adoption of Q12 in Singapore at the end of 2019 there was a lot of rumbling from regulatory agencies on how Q12 would be more aspirational in many ways. In the last few weeks we’ve started to see just what that will mean.

FDA to release a guidance

The FDA’s Mahesh Ramanadham, from the Office of Pharmaceutical Quality in the FDA’s Center for Drug Evaluation and Research, provided an update on the agency’s implementation of ICH Q12 in the US on 25 February at the annual IFPAC meeting in North Bethesda, Md. He started that the FDA will soon be issuing guidance implementing the International Council on Harmonization’s Q12 guideline in the US that will, among other things, translate ICH post-approval change classification categories to FDA supplement categories, and address how to file established conditions (ECs).

This Q12 guidance will replace the agency’s 2015 draft guidance for industry on established conditions and reportable chemistry, manufacturing and controls changes to approved drug and biological products. It is expected to be issued in May 2020. The guidance will also discuss the relationship between FDA comparability protocols and the post-approval change management protocol (PACMP) established by the ICH Q12 guideline.

EU says not so fast in their adoption

However, additional scientific risk-based approaches to defining Established Conditions and
associated reporting categories, as described in Chapter 3.2.3, and the Product Lifecycle
Management (PLCM) Document, as described in Chapter 5, are not considered compatible with the
existing EU legal framework on variations.

It is important to note that the legal framework always takes precedence over technical and
scientific guidelines. More specifically this means that the definition of Established Conditions and
their reporting categories must follow the requirements laid down in the current EU Variations
Regulation and associated EU Variations Guidelines. With respect to the Product Lifecycle
Management (PLCM) document, in case such a document is submitted, it cannot be currently
recognised in the EU due to the fact that it is not referred to in the EU legal framework.

EMA/CHMP/ICH/78332/2020

In an explanatory note accompanying the adoption of ICH Q12 and related annexes, the European Commission and the European Medicines Agency point out that there are “some conceptual differences” between the ICH guideline and the EU legal framework on managing post-approval changes, ie, the variations regulation (Regulation (EC) No 1234/2008).

The EU authorities offer no clarity on when and how ICH Q12 would be fully implemented in the EU. The note merely states that the new “tools and concepts in the ICH Q12 guideline that are not foreseen in the EU legal framework will be considered when this framework will be reviewed.” The EU regulators said they would continue to work on the implementation of the ICH Q12 within the existing EU legal framework. The explanatory note also points out that despite some conceptual differences between ICH Q12 and the EU framework, there is also considerable common ground. In fact, some tools and concepts in ICH Q12 tools can already be applied by industry by following the current EU variations framework.

Next Steps

Companies should be ensuring that their knowledge management and risk management processes and understanding continue to grow. ICH Q12 will be a rocky road and I’m not sure we’ll see some of the potential streamlining of regulatory processes for a long time.

ICH Q12 pathway for established conditions