The production process control procedure explains the QMS requirements for controlling your medical device production process.
Production Process Control Procedure
The purpose of this procedure is to define the overall production process controls, while the product-specific controls are documented in the technical documentation for each product or product family.
This procedure covers production process controls that have been implemented. It does not include outsourced contract manufacturing. Contract manufacturing is controlled in accordance with the Supplier Quality Management Procedure (SYS-011). The procedure includes all six of the production process controls specified in Section 7.5.1a-f of ISO 13485:2016. The procedure also includes requirements for traceability (covered in more detail within SYS-032, Identification & Traceability).
This is one of the documents meeting the applicable regulatory requirements for Production Processes Controls as defined in Quality System Manual (POL-001). The procedure does not include all of the details for a specific manufacturing process. Instead, the individual manufacturing process requirements are intended to be included in a Device Master Record (DMR) and/or Technical File (TF). Ideally, these two documents would be satisfied by an index that meets both requirements (e.g., FRM-040, TF/DMR Index Template included with SYS-025, Technical Documentation). There is also a section in the procedure to list each of your DMR indices to provide a quick reference list for internal and external auditors.
When is the live webinar scheduled for this procedure bundle?
The live webinar is scheduled for Monday, September 23, 2024 @ 10:30 a.m. ET. If you purchased the procedure before September 23, you will receive login information to participate in the live webinar. The webinar will be hosted in Streamyard.com. If you are unable to participate in the live webinar, please send us your questions in advance so that we can be sure to address your questions in the live webinar. You will be able to download the recording from the Dropbox folder after the live webinar and you can watch it as many times as needed.
What is included in the Production Process Control Procedure:
This document is updated for ISO 13485:2016 and the new European Regulations. We also added a simple, one-page template for a Device History Record (DHR) release checklist. The following is a list of documents included:
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About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510k submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Instagram.