ERP & FDA Validation: The Benefits of an ERP System to Support Supplier Management

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Learn about the three areas where an ERP system can support compliant supplier management. In an FDA-regulated industry, it’s not uncommon to utilize suppliers for components of their finished products.

As not all parts may be produced on site, the weight of compliance – and, ultimately, product quality – belongs to the company receiving the product or service.  The selection, approval and ongoing evaluation of suppliers is heavily regulated and a critical responsibility for manufacturers.

Supplier ApprovalERP & FDA Validation: Supplier Management | Copley Consulting Group

Quality control is highly dependent on your suppliers. Entities not covered by your internal quality audit are considered to be a supplier. The FDA advises that your primary criteria in selecting a supplier be its “ability to meet specified requirements including quality requirements.” As such, a rigorous supplier evaluation is an important element of the expectations laid out by the FDA in 21 CFR 820. Here are some points to consider under that umbrella.

  • Does the company have experience in your industry and/or with a similar product set?
  • Does the supplier have the bandwidth to confidently manage your work?
  • Have the supplier’s components been involved in any product failures or recalls?
  • To support your compliance, it is critical that along with your list of approved suppliers, you document your vetting and approval process. This may include selection criteria, references, audits and performance evaluations – all of which can be securely stored in your ERP system.

Business Agreements

“We have dozens of processes that needed to be followed with precision as we manufacture products for highly specialized customers. With Infor and Copley, we feel we have the right partners in place to help us integrate engineering with production, while providing us with analytical insights to help enhance quality, lower pricing, enable faster product delivery, and improve overall customer service.”

-Anthony Lorenzo, Chief Executive Officer of Blickman Industries.

Your contract with your supplier is the navigation set for your supplier relationship and the expectations associated with it.

A supplier agreement should contain clauses related to your level of standards for delivery, quality and validation. The contract should also, per the FDA, request that the supplier notify you of changes in the product or service so you can determine whether the changes will affect the quality of a finished product. Within your ERP system, you can manage your agreement and be assured all parties, including your accounting and inventory departments, are referencing the most recent contract. By managing your supplier contract within your ERP, users are able to easily reference related documentation, such as product- and supplier-specific quality plans within the system.

As an example, Blickman had low visibility into what was happening on the shop floor, with almost no insight into how the engineering drawings on the floor were being translated into final product. As a provider of stainless steel and chrome cabinets, stools, hampers, and other solutions for the medical field, the company needed to improve upon the very labor-intensive, manual processes it had in place.

In terms of working more efficiently with suppliers, the roll out of a new barcode inventory solution will help Blickman better track materials in the production cycle. Blickman is also integrating the ERP system with its SolidWorks® CAD software for the passthrough of bill of materials in support of new product development. 

 

 

 

ERP & FDA Compliance

 


Filed Under: Blog, FDA Validated