Conformité de la fabrication

La conformité de la fabrication garantit le respect des réglementations en intégrant les exigences techniques, juridiques et d'entreprise, dans le but de produire et de commercialiser des produits tout en atténuant les risques, en garantissant la sécurité des consommateurs et en respectant les normes de qualité.

What is manufacturing compliance?

Le risque de non-conformité est devenu une préoccupation de plus en plus importante ces dernières années, en particulier pour les fabricants qui exercent leurs activités dans plusieurs pays et différentes juridictions. Il devient de plus en plus difficile de se conformer à toutes les réglementations en matière de fabrication en raison de l'implication croissante des organismes de réglementation gouvernementaux dans certains secteurs industriels, ainsi que de l'apparition de normes mondiales de conformité visant à répondre à la mondialisation croissante de la production.

Pour garantir la conformité de la production à cette liste croissante de réglementations, de nombreuses entreprises utilisent désormais des logiciels de conformité et de contrôle des documents, qui font tous deux partie intégrante d'une solution logicielle de gestion de la qualité (QMS).

Les fabricants doivent intégrer la conformité aux normes de fabrication lorsqu'ils visent des objectifs stratégiques tels que la production de produits compétitifs, la rentabilité et la croissance de leurs activités dans un contexte de mondialisation croissante et des coûts élevés du développement de produits. Dans des secteurs allant de la fabrication de dispositifs médicaux et biotechnologiques à l'industrie automobile, les efforts pour atteindre ces objectifs sont encore plus décourageants en raison des exigences de conformité de la fabrication émanant de nombreux organismes réglementaires différents, même au sein d'un même pays. Aux États-Unis, par exemple, les fabricants doivent se conformer aux normes de qualité et aux réglementations de la Food and Drug Administration (FDA), de l'Environmental Protection Agency (EPA), de l'Occupational Safety and Health Administration (OSHA) et de la Securities and Exchange Commission (SEC), entre autres.

De nombreux domaines de la conformité de la fabrication peuvent concerner directement ou indirectement les fabricants :

Sûreté produit
Santé, sécurité et impact environnemental
Protection des données
Contrôle des exportations
Lutte contre la corruption
Sûreté et sécurité informatique
Concurrence loyale
Droit du travail

Produits connexes : Opcenter Quality, Teamcenter Quality and Compliance Management, Opcenter Execution

Understand the benefits

Consumer safety and product quality assurance

Adherence to regulations like Good Manufacturing Practices (GMP) ensures the implementation of robust quality systems and processes, minimizing risks associated with substandard products.

Operational eficiency and cost reduction

Streamline and optimize internal processes to meet industry and regulatory requirements, leading to improved productivity, reduced errors and proactive mitigation of potential disruptions.

Risk mitigation and legal protection

Identify and address potential regulatory issues, establishing a documented framework that demonstrates proactive adherence to standards and reducing the likelihood of legal issues or fines.

Types of manufacturing regulations and compliance mandates

Manufacturing compliance in some sectors – most notably, medical device and drug manufacturing – centers around the FDA’s manufacturing regulations. The core mandate guiding FDA regulatory oversight is consumer safety. As a result, the FDA has defined Good Manufacturing Practices (GMP) for both device and drug manufacturers, which dictate the measures that must be taken to ensure that quality systems and processes are in place to consistently produce safe, quality products. Therefore, manufacturers in these sectors seek a manufacturing certificate of compliance indicating that they meet GMP.

Software developers have responded to this need by creating solutions for managing regulatory compliance within QMS and manufacturing execution systems (MES). For those in manufacturing sectors regulated by the FDA, these solutions must be compliant with Title 21 CFR Part 11 and Part 820. Part 11 requires pharmaceutical manufacturers, medical device manufacturers, biotech companies, biologics developers, contract research organizations and other FDA-regulated industries (with some specific exceptions) to implement controls. These controls include audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule.

With the advent of globalization, international standards have become increasingly important to manufacturers looking to be compliant across international markets. With the implementation of the EMC Directive (i.e., European Machinery Directive) and similar regulations in other countries, regulatory compliance has become a major milestone in product development and marketing for most manufacturers. Key international industry standards for manufacturing compliance include:

ISO 9001
ISO 13485
IEC 61215
IEC 61646

Moreover, new and harmonized standards for manufacturing compliance continue to be developed.

Management Imperative for Compliance

Meeting the challenge of manufacturing regulatory compliance requires establishing a consistent top-down strategy for ensuring compliance across the enterprise.

If management fails to create an environment that ensures manufacturing compliance – or lacks documentation to prove all necessary steps have been taken to achieve it – it can be held accountable for compliance breaches. Because of this, manufacturing compliance must be an ingrained part of day-to-day business operations and therefore part of the organizational culture. Employee involvement in and acceptance of compliance tasks, including a complete understanding of manufacturing regulations, requirements and objectives, are integral parts of a sound compliance practice for manufacturing.