Let's Talk Quality – Insights From A Former CEO
Source: Life Science Leader
By Rob Wright, Chief Editor, Life Science Leader
Follow Me On Twitter @RfwrightLSL
By Rob Wright
A reader reached out to me to suggest Life Science Leader magazine do more to cover compliance/quality systems. He sees this as being the biggest issue facing the industry today, and that quality transcends the entire executive leadership team. As a former president and CEO, I guess he would have some pretty good insight. He states, “Most of the time it isn't understood. You can have great quality systems and poor decisions and hence poor quality/compliance. You can have horrible quality systems and good decisions and hence, good quality/compliance.”
What Is J&J Doing To Fix The Problem
In an email, this former executive informed me that the “Quality/Compliance” tab on the website got his attention. I wrote back to see what was on his mind, and here is what he had to say. “If you want to identify with quality failure, just look at the FDA website,” he states. “You will see numerous 483 warning letters.” With regard to manufacturing, he goes on to point out that many companies were cited by the FDA, responded as is required by law, only to have their response rejected for failure to address the issues. “If you want an idea of big failures, try and find Johnson and Johnson/McNeil products (i.e. Children’s Tylenol or Tylenol branded products) on any pharmacy shelf for the last couple of years,” he suggests. Personally, I would love to sit down with William Weldon, CEO of J&J (NYSE: JNJ). Not to drag him or the company through the mud, but to find out what they are doing about getting back on top. J&J has a proud history of dealing with recalls. In 1982, Tylenol product tampering killed a customer, and the company implemented a product recall at a cost of $75 million. This became the model for how to do a product recall. Their ability to act quickly has been attributed to J&J leadership referencing the company’s rank ordered values – number one being – the safety and well-being of the patient. I want to know, what best practices and actionable information could Weldon share from the company’s recent experiences, and what plan of action have they put in place to handle moving forward. I believe our executive readers would find this information useful in their own business planning. Mr. Weldon, if you would like to discuss this, send me an email at rob.wright@lifescienceconnect.com.
Former CEO Shares Personal Experience
Obviously, recalls and warning letters are a touchy subject. “I doubt many companies are going to want to talk about these issues even in terms of remediation, as they are embarrassing even with a successful remediation program,” says this former CEO. He goes on to explain why. “I doubt anyone is going to want to highlight their past sins since such remediation usually requires organizational change, dismissals of QA/QC staff, potential closure of facilities, job loss, and the potential for adulterated product, etc.” In his former career, he had the painful experience of dealing with this firsthand, the eventual result being the closing of a plant. A small mistake (to my understanding this was traced back to negligence) resulted in damaged product, product recalls, lost manufacturing jobs, lost sales revenue, as well as the softer components which are difficult to measure — negative effects on brand equity, corporate image, and trust.
I asked this former CEO what metrics he would advise companies use to improve quality/compliance. His response, “It’s quite simple — it’s called the FDA.” He continues, “It is becoming an epidemic within the industry. Most people see it as issue oriented. It is now becoming, or should become, more of a mindset and a corporate value that needs to transcend the boardroom.” He would like to see LSL cover this topic more because, “It isn’t understood to the level that is needed.”
I appreciate the feedback and the suggestion. In a few weeks I will be attending a pharmacovigilance conference. Perhaps I will meet some people willing to share best practices in the areas of quality/compliance.
In an email, this former executive informed me that the “Quality/Compliance” tab on the website got his attention. I wrote back to see what was on his mind, and here is what he had to say. “If you want to identify with quality failure, just look at the FDA website,” he states. “You will see numerous 483 warning letters.” With regard to manufacturing, he goes on to point out that many companies were cited by the FDA, responded as is required by law, only to have their response rejected for failure to address the issues. “If you want an idea of big failures, try and find Johnson and Johnson/McNeil products (i.e. Children’s Tylenol or Tylenol branded products) on any pharmacy shelf for the last couple of years,” he suggests. Personally, I would love to sit down with William Weldon, CEO of J&J (NYSE: JNJ). Not to drag him or the company through the mud, but to find out what they are doing about getting back on top. J&J has a proud history of dealing with recalls. In 1982, Tylenol product tampering killed a customer, and the company implemented a product recall at a cost of $75 million. This became the model for how to do a product recall. Their ability to act quickly has been attributed to J&J leadership referencing the company’s rank ordered values – number one being – the safety and well-being of the patient. I want to know, what best practices and actionable information could Weldon share from the company’s recent experiences, and what plan of action have they put in place to handle moving forward. I believe our executive readers would find this information useful in their own business planning. Mr. Weldon, if you would like to discuss this, send me an email at rob.wright@lifescienceconnect.com.
Former CEO Shares Personal Experience
Obviously, recalls and warning letters are a touchy subject. “I doubt many companies are going to want to talk about these issues even in terms of remediation, as they are embarrassing even with a successful remediation program,” says this former CEO. He goes on to explain why. “I doubt anyone is going to want to highlight their past sins since such remediation usually requires organizational change, dismissals of QA/QC staff, potential closure of facilities, job loss, and the potential for adulterated product, etc.” In his former career, he had the painful experience of dealing with this firsthand, the eventual result being the closing of a plant. A small mistake (to my understanding this was traced back to negligence) resulted in damaged product, product recalls, lost manufacturing jobs, lost sales revenue, as well as the softer components which are difficult to measure — negative effects on brand equity, corporate image, and trust.
I asked this former CEO what metrics he would advise companies use to improve quality/compliance. His response, “It’s quite simple — it’s called the FDA.” He continues, “It is becoming an epidemic within the industry. Most people see it as issue oriented. It is now becoming, or should become, more of a mindset and a corporate value that needs to transcend the boardroom.” He would like to see LSL cover this topic more because, “It isn’t understood to the level that is needed.”
I appreciate the feedback and the suggestion. In a few weeks I will be attending a pharmacovigilance conference. Perhaps I will meet some people willing to share best practices in the areas of quality/compliance.
This website uses cookies to ensure you get the best experience on our website. Learn more