-
Quality System
a. A quality system must be established that is appropriate to the product
produced. Various controls, procedures and specificationsrequired must be
defined and documented. Typically the quality system includes:
i. Statement of Quality Objectives
ii. Organizational structure with specific quality
responsibilities
iii. Procedures and policies to establish and control
the quality system
iv. Required resources
-
Document Controls and Changes
a. Everything in a regulated environment must be controlled. This means proper
identification, documentation, and change control. Procedures to control the
following are required:
i. Documents
ii. Records
iii. Changes
iv. Equipment
v. Quality assurance
-
Device Master Record
a. The Device Master Record consists of all of the documentation that is
required to produce the product:
i. Instructions
ii. Specifications
iii. Drawings
iv. Procedures
-
Device History Records
a. Device History Records contain all the records generated in producing
specific products:
i. Purchasing records
ii. Work orders
iii. Dispositions
iv. Acceptance records
-
Design Controls
a. There are specific procedures and controls that must be implemented for
design that include the following (Design controls must be in place for Class
II, III and a few Class I devices);
i. Create and update a Design Plan
ii. Collect and document adequate Design Input
iii. Plan and conduct Design Reviews as
necessary
iv. Create and document the Design Output.
Specifications, drawings, procedures, etc.
v. The Design must be properly Verified and
Validated
vi. Document the transfer of the design to
production.
vii. Design Changes must be controlled documented and
verified.
viii. A file containing a complete Design History must
be kept
-
Process Validation
a. This requirement is designed to assure that objective evidence and
documentation exists that a process consistently produces a result or product
meeting its predetermined specifications and must include:
i. Equipment validation
ii. Manufacturing processes
iii. Process performance
-
Personnel and Training
a. Proof must exist that the staff is qualified and properly trained.
i. Employee selection process
ii. Employee training documentation
-
Buildings and Environment
a. Adequate facilities must be defined and be available as appropriate
i. Facility requirements
ii. Environmental control
iii. Contamination control
-
Equipment and Calibration
a. Equipment must be adequate, properly maintained, and calibrated per a
predetermined schedule
i. Equipment selection, installation, and
validation
ii. Equipment maintenance
iii. Calibration requirements and records
-
Purchasing
a. Component specifications, supplier assessment, receiving components and
services must be controlled with procedures and policy.
i. Component specifications
ii. Supplier Qualifications iii. Incoming goods
inspection and acceptance procedures
-
Acceptance and Testing a. Quality assurance and testing is an important part of
any quality system and requires written procedures and documentation including
the following areas:
i. Acceptance criteria
ii. Quality procedures
iii. Inspection/Testing procedures and policy
iv. Acceptance and rejection records
v. Proper component storage to avoid mix-ups.
vi. Control numbers for critical components
vii. Acceptance sampling plans
viii. Final product evaluation
ix. Labeling and packaging inspection
x. Controls for product release
-
Labeling
a. Labeling includes any information associated with the product and includes
labels, instructions, advertising. Labeling must be properly documented and
controlled including:
i. Proper Identification
ii. Adequate directions for use
-
Packaging
a. Packaging requires procedures and documentation verifying that it is
adequate for the product.
i. Package design controls must be in place
ii. Proper materials
iii. Packaging must be validated as appropriate
iv. Packaging procedures must be in place
-
Storage and Distribution
a. Finished product must be safely stored and adequate distribution records
maintained.
i. Holding and distribution procedures
ii. Distribution records
iii. Installation, training on proper use of products
must be available if necessary.
-
Corrective / Preventive Action / Complaint Files
a. CAPA is often the focus of regulatory requirements and must be actively
implemented for both internal (production, engineering, etc. problems), and
external (customer complaints, concerns and comments.
i. An active and well documented CAPA system should be
in place
ii. A complaint handling system is required
iii. An investigation policy for evaluating internal
and external problems
iv. Complaint records maintained and evaluated.
v. Quality system feedback for continuous quality
improvement
vi. Procedures for Medical Device Reporting (MDR) of
adverse events to the FDA must be available
-
Servicing
a. Policies for repair and/or replacement are similar to the requirements for
new product
i. Adequate and trained personnel
ii. Service procedures
iii. Acceptance procedures
iv. Proper documentation
v. Analysis of problems and trends
-
Internal Quality Audits
a. The QSR requires that internal quality audits are performed on a regular
basis and problems and non conformances corrected
i. Audit procedures established
ii. Audit schedule determined
iii. Audit criteria
iv. Corrective actions
-
Product Evaluation
a. Appropriate testing and inspection must be implemented and records
kept.
i. Failure analysis performed if necessary
ii. Preventive and Corrective Actions performed as
necessary
iii. Procedures for handling nonconforming product
|