Determine the suitability, adequacy, effectiveness and
consistency of the supplier’s processes to meet contractual requirements and
to provide a basis of confidence for product/service acceptance.
Process
1.
Determine Processes to be Reviewed - Identify
processes in accordance with
GCQA Surveillance Planning. 2.
Determine the Scope of Each Process Review - The
scope of each review shall be determined based on the applicable risk
impact.If the risk impact is rated as high, then all process
elements shall be reviewed. If the risk impact is rated moderate or low, the review may cover all elements or
selected portions. Process Review Planning documentation shall identify the
steps to be reviewed. Items with CSI requirements have
an associated list of
important manufacturing processes which may be used as a planning
tool in performing Process Review for any complex item. 3. Determine
the Appropriate Review Method for Each Process - A process may be reviewed as a single event or
incrementally. Planning for an incremental Process Review shall include
identification of
all the process elements planned for each increment. Subsequent review
increments are
scheduled over a specified time period
until all the planned elements have been reviewed. 4.
Conduct the Process Review for Each Process -
QA personnel shall review each selected process to determine
its adequacy in consistently
producing a conforming product. The Process Review shall begin
with a review of the supplier’s documented procedures for each process
selected. QA personnel will assure that
the procedures identify the important aspects in the right
sequence, sufficient controls are in place, and any special skills
are addressed. The procedures shall be adequate to meet all contractual
requirements as noted in the contract (e.g., ISO 9000-2008, applicable
drawings, the Statement of Work, specification requirements, or other
related requirements) and should address
the five key elements of a process that includes the process elements (4M+E) necessary to
produce the product.
Methods
Manpower
Material
Machinery
Environment
4.1. For non-complex, critical
items (as identified by contract e.g. critical application item), this may involve only one or two of the
most critical processes that determine the quality of the product. For more
complex manufacturing facilities or facilities producing products that
include a Critical Characteristic or that may involve Safety of Flight, Navy
Special Emphasis, NASA, Life Support, etc., QA Personnel are encouraged to
use an analytical tool such as a flowchart to reveal
how the supplier plans to control each of the five key process elements
throughout the manufacturing process.
4.2. The
sample checklists provide suggested process
elements that QA Personnel should take into account in performance of a Process
Review.
4.3.
During review of process inputs and controls, QA Personnel shall:
Assess inputs against the technical requirements
Witness and evaluate process steps/activities
and controls in use
Perform a Product
Examination to ascertain if the process results meet the
specified output requirements
5.
Document Results - All inputs and output data
reflecting each process element (e.g., 4M+E) shall be documented. QA
Personnel shall accurately record the results of the Process Review when
completed and in a suitable manner which will allow for use during
data analysis (See
Data Collection & Analysis process). Data points
(Supplier and Government) identified during
Process Reviews may be used to monitor ongoing process performance. As a minimum, the records shall
contain:
Date of review
Person accomplishing review
Supplier name
Location of the review
The process reviewed
Supplier Procedure/Documentation references,
revision number and date
The items being processed at the time of the
review by nomenclature,
part number, serial number, batch number, etc.
Elements of the process reviewed (e.g., 4M+E)
Steps of the process reviewed
Non-conformances found
Traceable to corrective actions
6.
Notification of Results - The results of the Process Review should be
discussed with the supplier (and customer, if applicable) to include possible opportunities for
improvement for processes exhibiting variations. QA Personnel shall initiate immediate
corrective action (See
Corrective Action
Process) when the results indicate a contractual nonconformity.