The Critical Process
(Pre-Audit) Assessment

What MedMMAP Will Do

  • Conduct free a Critical Process Assessment (“pre-audit”) to the MedAccred audit criteria.
  • Work with the supplier to develop a gap closure plan. 
  •  Train and mentor the supplier team in gap closure and accreditation audit preparation.
  • Audit all non-conformances following gap closure, prior to the PRI MedAccred audit.
  • Assist the supplier in closing any PRI MedAccred audit findings.

The Critical Process Assessment (Pre-Assessment Audit) is conducted to the MedAccred audit criteria used in an accreditation audit. 

The time for the Critical Process Assessment  is the same as the accreditation audit.

A MedMMAP Critical Process Assessment is based on MedAccred’s industry-approved criteria and includes a review of the procedures, work instructions, training records and other documentation that evidences the competency of the company to meet customer requirements. 

A Critical Process Assessment also involves observing the critical processing through job audits to ensure that documented requirements are properly flowed down to and implemented on the shop floor.  

A job audit is a step-by-step review of the critical process for producing an item and evaluating how the customer requirements are met by using the MedAccred audit criteria.

What makes a MedAccred Audit different from a QMS audit?

MedAccred Subscribers are leading medical device industry OEMs who drive a common audit criteria

Medtronic

Baxter

Philips

Johnson & Johnson

BD

Stryker

Bausch Health

Boston Scientific

Roche Diagnostics

Edwards Lifesciences

Subscribers manage program, determine all audit criteria, interview and select the auditors,
have full access to audit findings and determine who is granted MedAccred Accreditation.

Critical Process Accreditations

Plastics

Plastics – Extrusion
  • Tubing / Profile
  • Sheet / Film
  • Blown Film
  • Over-Jacketing
  • Co-Extrusion
  • Ram Extrusion
Plastics – Injection Molding 
  • Compression Molding
  • Injection Blow Molding
  • Insert Molding
  • Overmolding
  • Transfer Molding
Plastics – Mechanical Assembly
  • Adhesives / Bonding
  • Mechanical Fasteners
  • Plastics Welding
  • Heat Staking

Electronics

Printed Circuit Board Assemblies (PCBA)
Printed Boards (Bare Boards)
  • Flexible*
  • Rigid*
Cable & Wire Harness

STERILIZATION / PACKAGING / LABELING

Sterilization
  • Ethylene oxide
  • Radiation (Gamma & E-Beam)
Sterile Device Packaging
  • Assembly of Packaging Systems
  • Sealing
  • Forming Sterile Barrier Systems*
Labeling / Printing / UDI*

METALS

Heat Treating
  • Metal Systems 
  • Heat Treating Processes 
  • Heat Treating Equipment 
  • Brazing (Vacuum Brazing / Atmosphere Brazing)
  • Sintering*
Welding
  • Electron Beam 
  • Laser 
  • Resistance Welding*
  • Fusion 
    • GTAW (TIG)
    • GMAW (MIG)
    • Plasma

*audit criteria under development

A Critical Process Assessment (like the MedAccred audit) is not a Quality Systems (QS) Audit, but a detailed technical audit focused on the specific commodity requirements.

Results from the Critical Process Assessment are used by MedMMAP and the company to develop and execute a plan to close all non-conformances and root cause corrective actions.  

The MedMMAP Critical Process Assessment meets the MedAccred requirement that a supplier perform an internal pre-audit prior to the accreditation audit.

MedMMAP

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