BE 410/Engr 420

Howard Davis Ph.D.

 Housekeeping

• Office HRs: M,W,F 9-10 Commons Fri 12-2 or

by appointment
• Quality Manual – Where we are in process
• By Next Tuesday – Preview your portfolio
upload link to BlackBoard
• Document Control and Example Docs due 10-
29
Document Control

• Why?
 Quality Manual Review
Documentation requirements
General
• Documenting the quality policy and objectives
• Documenting the quality manual
• Documenting the quality management system
procedures
• Documenting the information needed for the effective
operation and control of processes
• Documenting records
 Quality Manual Review
Control of documents
• Controlling documents required by the QMS
• Establishing document control procedures
• Approval of documents
• Review and revision of documents
• Re-approval of documents after revision
• Identifying revision status
• Availability of documents
• Identification and legibility of documents
• Control of documents of external origin
• Control of obsolete documents
• Identifying obsolete documents retained for use
 Quality Manual Review
Control of records
• Establishing and maintaining records of
conformity
• Establishing and maintaining records of
effectiveness
• Ensuring legibility of records
• Ensuring identification of records
• Retrieval of records
• Describe the methods of collating, printing and binding of the
DHF, DMR, DHR, and TDF
• Establishing a records control procedure
 Quality Manual Review
DHF: Design History File

This is the compilation of All the records that describe

the history of the design of a finished device. This would
include (not exhaustive):
• Design plans
• Review minutes
• Sketches, Drawings, Photos
• Procedures
• Engineers notebooks or journals
• Component qualification information
• Verifications
• Validations
• Protocols for verification and validation
Quality Manual Review
Design History File
 Design Master Record documents that show
plans were followed and specifications were met
• DMR: Design Master Record
• These are the records that specify the finished device. These
include standard operating procedures (SOP). It is important that
all revisions are part of the record so that each device can be
traced back to the DMR under which it was produced. Items that
would be included:
• Device specifications: drawings, composition, formulation,
software specifications.
• Production process specifications, production equipment specs,
methods, procedures, production environment specifications
• Quality assurance procedure and specifications, acceptance
criteria, testing equipment specifications
• Packaging and labeling specifications, methods and processes
• Usage documents, manuals, installation, maintenance, servicing
 DHR: Device History Record

• This is the production record for a

specific device and must be traceable
to a DMR that describes the build
specifications for each specific device.
These things would be included:
• Dates of manufacture
• Quantity
• Quantity released for distribution
• Acceptance records
• Identification labeling for each
production run
• Any device ID or control numbers
 TDF: Technical Documentation File

• The TDF must be kept for 10 years and contains all the
relevant design data that demonstrates that safety
requirements were met as formulated in the DMR. It
includes:
• Description of the product
• Design description (drawings, methods of manufacture)
• Results of risk analysis and list of applicable standards and
solutions
• If sterile product: description of the method
• Results of design calculations and modeling
• Results showing it can interface properly to the external
environment (power, temperature etc).
• Test reports and clinical data
• Labels and instruction for use
Quality Manual Review
IRB and HIPPA
Time to start putting the pieces together!

•You should be actively

networking toward your
Portfolio Reviewer
•Next Tuesday:
 I want to see the beginnings of your
actual portfolio – do check out the
resources on Black Board