Author: Stéphane Gumy, General Manager PM Systems S.a.r.l
For more than 20 year now, I work for the pharma and medical device industry and have observed the evolution in this industrial segment concerning two extremely important aspects: the Compliance and the Quality.
Year after year, Compliance have become more important compared with the Quality. That has led to amazing situations such as:
• In case of hard Brexit, non-recognition of UK-notified body or CE mark certification delivered by UK-notified body.
• Delay in the renewal of CE-certification for a medical device class III, that is commercialized since more than 10 years, because the notified body needs several months to reassert the biocompatibility report and design file.
• Performance of inspections and inspection by authorities, that focused only on formal aspects related to regulations, without taking into consideration the specific environment and/or Quality aspects related to the products.
• Position-taking and decision made by decision makers such as QA Manager and auditors based on regulatory interpretation only, without taking into consideration the specificities related product Quality. That because the decision makers have a poor level of scientific knowledges and because they have no understanding regarding the technical situation.
• Rupture in the commercialization of medical devices, because the notified body has not the resources to renew the CE certificate on time.
These real-life examples raise some important questions:
• What should be thought of these situations?
• What is the impact on the product Quality and the patient safety?
• Where is the correlation between Compliance and Quality?
• What is the justification to act or to take decisions like that?
• Is the effort related to Compliance aspects always justified?
• How are the different decision makers (authorities, political decision makers, …) competent?
Let’s think about these situations and let’s reply to these open questions.
All too often Compliance and Quality are confused. The Compliance do not ensure the product quality. For example, a manufacturer can meet regulatory requirements and still make a poor-quality product, whereas another manufacturer may not comply with all regulatory requirements and make a high-quality product.
That is quite understandable, because Compliance essentially covers the conformance in regard to the directives and the regulations and because Quality essentially covers safety and efficacy aspects.
As mentioned above, with the time we can observe a drift from Quality to Compliance. But there are still some differences and it depends on the industrial sector. In the pharma sector, a concept is well established for many years: the Qualified Person is responsible for Quality. Usually the Qualified Person is in charge of all Quality Affairs (QA & QC) and also deeply involved in RA aspects. In the medical device sector, the change of the regulation from the MDD to MDR integrates a new function: “PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE“. According to the article 15, MDR, the person responsible for regulatory compliance shall at least be responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. Fine, … but now the question is “Should that not be the mission of the QA?”. It looks like that the Regulatory Compliance overhead the Quality Assurance!
Do we want to continue to go in this direction?
In my opinion, all decision makers such as the QA Managers, the auditors, the inspectors, the safety assessors, etc. should base their decisions and actions using a risk approach guaranteeing the product Quality and patient safety. We should avoid to apply the regulations as doctrine, but we should be able to think and to interpret the regulations in the light of specific situation taking into consideration all scientific and technical aspects. And decision makers should acquire more process knowledge and understanding for Quality.
In summary, my conclusions: we should do less, but we should do it better. Go back to the essential focusing on Quality taking in consideration safety and efficacy aspects, instead of focusing on Compliance. That requests a big deal of courage, considerable effort and a lot of time. But let’s do it… it’s worth it!
Compliance vs. Quality
Author: Stéphane Gumy, General Manager PM Systems S.a.r.l
For more than 20 year now, I work for the pharma and medical device industry and have observed the evolution in this industrial segment concerning two extremely important aspects: the Compliance and the Quality.
Year after year, Compliance have become more important compared with the Quality. That has led to amazing situations such as:
• In case of hard Brexit, non-recognition of UK-notified body or CE mark certification delivered by UK-notified body.
• Delay in the renewal of CE-certification for a medical device class III, that is commercialized since more than 10 years, because the notified body needs several months to reassert the biocompatibility report and design file.
• Performance of inspections and inspection by authorities, that focused only on formal aspects related to regulations, without taking into consideration the specific environment and/or Quality aspects related to the products.
• Position-taking and decision made by decision makers such as QA Manager and auditors based on regulatory interpretation only, without taking into consideration the specificities related product Quality. That because the decision makers have a poor level of scientific knowledges and because they have no understanding regarding the technical situation.
• Rupture in the commercialization of medical devices, because the notified body has not the resources to renew the CE certificate on time.
These real-life examples raise some important questions:
• What should be thought of these situations?
• What is the impact on the product Quality and the patient safety?
• Where is the correlation between Compliance and Quality?
• What is the justification to act or to take decisions like that?
• Is the effort related to Compliance aspects always justified?
• How are the different decision makers (authorities, political decision makers, …) competent?
Let’s think about these situations and let’s reply to these open questions.
All too often Compliance and Quality are confused. The Compliance do not ensure the product quality. For example, a manufacturer can meet regulatory requirements and still make a poor-quality product, whereas another manufacturer may not comply with all regulatory requirements and make a high-quality product.
That is quite understandable, because Compliance essentially covers the conformance in regard to the directives and the regulations and because Quality essentially covers safety and efficacy aspects.
As mentioned above, with the time we can observe a drift from Quality to Compliance. But there are still some differences and it depends on the industrial sector. In the pharma sector, a concept is well established for many years: the Qualified Person is responsible for Quality. Usually the Qualified Person is in charge of all Quality Affairs (QA & QC) and also deeply involved in RA aspects. In the medical device sector, the change of the regulation from the MDD to MDR integrates a new function: “PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE“. According to the article 15, MDR, the person responsible for regulatory compliance shall at least be responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. Fine, … but now the question is “Should that not be the mission of the QA?”. It looks like that the Regulatory Compliance overhead the Quality Assurance!
Do we want to continue to go in this direction?
In my opinion, all decision makers such as the QA Managers, the auditors, the inspectors, the safety assessors, etc. should base their decisions and actions using a risk approach guaranteeing the product Quality and patient safety. We should avoid to apply the regulations as doctrine, but we should be able to think and to interpret the regulations in the light of specific situation taking into consideration all scientific and technical aspects. And decision makers should acquire more process knowledge and understanding for Quality.
In summary, my conclusions: we should do less, but we should do it better. Go back to the essential focusing on Quality taking in consideration safety and efficacy aspects, instead of focusing on Compliance. That requests a big deal of courage, considerable effort and a lot of time. But let’s do it… it’s worth it!