Trying to respond to severe regulatory criticism? Do you need some essential guidance?
The story so far…
It is Friday, it is late and you are just leaving for the weekend. The inspection you hosted 2 weeks ago remains a painful memory. The exit meeting did not go well. There were five major observations all relating to your quality system. When your boss enters your office, you know it is not to wish you a good weekend.
She looks stressed, anxious and keen to offload a big problem. “We have received the regulator’s audit report. We now have one critical and seven majors and we have 15 days to respond in writing. Our license to operate is at risk. Please cancel your weekend. I need the draft response by Tuesday.”
So what do you do?
Firstly, acknowledge receipt of the report immediately. Always be respectful and polite, never defensive or officious. Keep this immediate communication short and to the point. Commit to providing a full and comprehensive response within the permitted time frame.
Emphasise your total commitment to fix the underlying causes and to address any immediate risks… and then leave for the weekend! This is not a frivolous point. So many responses are written by people who are tired, stressed and just not thinking straight. When putting anything in writing, imagine you are the regulator.
In writing the audit report, the regulator is (subconsciously) expressing two emotions. Fear over patient safety and/or lack of trust and confidence in your company. Your primary objective is to reduce both fears and engage in a dialogue that seeks to rebuild credibility.
Fear: The auditor’s primary objective is to safeguard public health. A damaging audit report means they have concerns about your company’s ability to manufacture products that are safe, efficacious and of the right quality. This may be due to specific observations or just a feeling that systems, procedures or practices are not in a state of control.
Lack of trust and confidence: Poor inspections quickly erode trust and confidence between the regulator and your company. The relationship between company and agency has been badly damaged. Remember, auditors are human!
Although good auditors base conclusions on facts, emotions (gut feel) will play an important part in how they perceive your company, your leadership and your quality culture. This is not a precise process and cultural differences can often sabotage good intent. These cultural differences can easily lead to miscommunication and misunderstanding that then create the gut feeling of distrust.
Doing any of the following during an inspection will erode trust:
- not answering questions clearly
- not providing documents quickly or using delaying tactics in general
- attempting to justify bad practices using risk assessment
- appearing to hide bad data
- not being transparent
- putting barriers in front of the inspector (making their life tough!)
- management answering all of the questions.
So, when responding to regulatory criticism, remember:
- your primary objective is to rebuild trust and remove fear. Don’t just focus on providing data and information
- accept that rebuilding trust and removing fear takes time, often years
- be consistent and genuine in your messaging. Don’t attempt to fake it
- even if you feel that you have been ill-treated or misunderstood, or the inspector was just having a bad day, remember the perception of the inspector is their reality, particularly when it is in writing!
- companies who feel victimised or unfairly treated often respond emotionally, making the situation worse.
Before writing to the regulators, remember the essentials:
- speed is of the essence. Make it clear which actions you will take immediately to protect patient safety
- be thorough in justifying why some products and markets are at risk and others are not
- do not just rely on words; phone calls and face-to-face meetings are always better
- choose your words carefully. If you were misunderstood once, it can happen again
- less is more. Make sure your response is easy to understand and easy to navigate. Regulators are busy people. Your response may be the centre of your universe but it is not the same for them
- a response that is simple to read and understand, and which conveys your desire to rebuild trust and respect by delivering what is needed, will be well received
- make sure your response is credible and that the resources and financial investment required will be made available. Fixing big problems without investment is not credible. Attempting to fix problems with the same thinking that created them will not be well received
- convey the support and active engagement of your senior leadership. Their involvement must be front and centre stage. After all, they are ultimately responsible.
Do not:
- openly disagree with the auditor’s findings
- state that you have been audited by other regulatory agencies who gave you a clean bill of health
- respond only to single observations and ignore the big picture
- treat the symptoms, not the cause. If you find yourself including statements such as ‘SOP rewritten,’, or ‘policy document updated’ or ‘retraining completed,’ rip it up and start again
- justify bad practice by using risk assessment, validation or spurious statistical methods
- over promise and under deliver
- be anything other than truthful and sincere.
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