Design Controls

Design Controls for different types of products. In general, they cover the

following  points :

• Approval of the design goals (Design Input) 
• Review of feasibility studies (Design Review) 
• Approval of the product description (Design Output) 
• Review of process development and preparation of manufacturing documents (Design Verification Review) 
• Review and approval of product validation (Final Design Review/Data Review) 
• Transfer to manufacturing

The specific procedures for the different product lines are referenced below.

Related Procedures:

• Definition of Product Design Goals for Assay Development 
• Design Controls 
• Procedural Elements in a Validation 
• Specific Immunoassay Validation Procedures 
• Procedural Elements in a Validation 
• Testing Protocol Request 
• Procedure for Developing Operational Procedures 
• Product Introduction/Product Improvement Procedure 
• Design Control and Transfer Worksheet 
• Product Development Request Form 
• Design Input 
• Design Output 
• Design Review Procedure

Corporate

• Risk Analysis and Management 
• Document Controls 
• To assure consistent quality, we use written, approved procedures for all operations.

The Document Control and Quality Assurance departments or their designee(s) are responsible for controlling the issue, distribution, revision and archiving of these procedures.

The documents that must be controlled include:

• The Quality Manual and Quality Systems SOPs
• Device Master Records 
• Internal Audit Reports 
• Standard Operating Procedures 
• Manufacturing Procedures 
• Testing/Inspection Procedures
• Calibration and Maintenance Records 
• Device History Records
• Design Control Records 
• Forms
• Essential Requirements and Technical Document Indexes

The formal Document Change Request (DCR) procedure for creating new documents and revising existing documents. It involves review and approval by multiple departments generally including a technical department, the affected department and the Quality Assurance department. The Hematology Division initiates formal Document Control in each Department. The Departmental Supervisor reviews a draft with assistance from designated individuals.

Related Procedures:

• Standard Operating Procedure (SOP) Review Procedure 
• Record Keeping Guidelines 
• Creating a Document
• Master Control Electronic Documentation System
• Master Control Functions 
• Document Change Request Procedure 
• Preparation & Maintenance of Document Master Files
• Master Document Replacement Procedure 
• Data Management: General Procedures & Definitions 
• New and Updated Procedure Protocols 
• Procedure Format 
• Document Organization (Document Control) 
• Procedure for Developing Operational Procedures 
• Updating the Device Master Record (DMR) 
• Format for "Product Description/Device Specifications" Documents 
• Format for "Product Type" Documents