To document a Government Contract Quality
Assurance (GCQA) surveillance plan that defines the methodologies
and techniques to reduce the likelihood of risk causes and establish
a basis of confidence that the supplies meet the quality and
technical requirements of the contract.
Process
1. Develop GCQA Surveillance
Plans - Quality Assurance (QA) personnel shall develop risk
based GCQA surveillance plans. See the QA Risk
Assessment instruction. Surveillance plans may be based on
a specific contract, program or facility. The surveillance plans
will vary based on the contractual quality and technical
requirements and associated risks. For
subcontractors with Letters of Delegation (LOD) to only verify or
witness specific tasks, a risk profile may not have been
developed. In such cases, the list of activities specified in
the delegation would serve as the surveillance plan. For
Quality Assurance Letters of Instruction (QALI) or LODs containing a
mixture of specific mandatory surveillance requirements and more
general identification of risks or surveillance activity, the
mandatory aspects do not need to be risk assessed, but shall be
identified in the surveillance plan. If QALI
requirements are believed to be excessive or vague, QA personnel
shall inform the customer and recommend alternative surveillance
strategies, supported by performance data and/or analysis. If the Contract Management Office (CMO) determines a customer QALI should be
rejected, the CMO shall obtain approval for the rejection from the
HQ Operations Directorate. The overall
scope of surveillance activity shall be based upon the results of
the risk impact assessment and traceable to each applicable risk
statement.The GCQA surveillance plan
shall indicate which risk statements have been delegated to a
supporting CMO.
1.1. Risk impact cannot be influenced by
GCQA surveillance; however the scope of the surveillance should be
based on the risk impact. The greater the risk impact, the
greater the scope of the surveillance. Higher risk impacts
might require system, process, and product surveillance whereas
lower risk impacts might only require occasional reviews of the
supplier’s control mechanisms. Similarly, higher impacts may
require surveillance of an entire process or system while lower
impacts might require surveillance of only selected elements.
1.2. Risk likelihood drives the frequency and
intensity of GCQA surveillance activity. Where the likelihood
of occurrence is high, surveillance should be performed more
frequently until the likelihood of occurrence is reduced to an
acceptable level. For the purposes of GCQA surveillance planning,
frequency can be expressed in terms of time e.g. every month or in
terms of throughput e.g. every 3rd lot. Intensity is most
typically used for Product Examination and can be expressed in terms
such as 100% or sampling terms such as Acceptable Quality Level
(AQL) or Verification Level (VL).
1.3. GCQA Surveillance Planning
for risk statements associated with First Article
Testing (FAT) and Critical Safety
Items (CSI) shall be performed and documented as prescribed in
the FAT and CSI instructions. Surveillance Plans for Safety
of Flight, National Aeronautics and Space Administration
(NASA)
support and Navy Special Emphasis Programs (NSEP) shall
be as prescribed in their own respective instructions.
1.4. When
requested by the DoD responsible activity, Qualified Product List
/Qualified Manufacturer List/Qualified Supplier List (QPL/QML/QSL)
surveillance shall be accomplished in accordance with the
instructions received. The requested surveillance shall be
performed even though there may currently be no contracts at the
supplier facility. When surveillance instructions are excessive e.g.
witnessing of lengthy or automated tests, Quality Assurance (QA)
personnel shall open a dialog with the issuing activity and propose
alternative surveillance. If an agreement cannot be reached the
issue shall be elevated through the chain of command. QA personnel
shall make their historical data on supplier operations available to
DoD activities conducting QPL/QML/QSL audits.
2. Surveillance plan details - Surveillance plans shall identify or reference the planned
surveillance activities that address each risk statement and risk
cause identified during contract technical review and risk
assessment. The plan shall address each characteristic,
product, process, or system identified as a potential risk cause and
identify the method(s), frequency, intensity (formerly level of
effort) and if applicable, schedule of surveillance. Scope,
intensity, and frequency for GCQA surveillance activities shall be
established to meet customer directed requirements, assure the
supplier is meeting contractual requirements and to establish and
maintain a basis of confidence for product/service acceptance. The surveillance methods, intensity and
frequency should be commensurate with the identified risk. See additional raw
material guidance.
2.1. When the contract technical
review identifies a requirement for a Quality Management System
(QMS) (52.246-11 Higher-Level Quality), the QMS or specific QMS
clauses shall be identified as a risk cause(s) and the plan
shall:
Identify System Audit as the method to be used.
Identify the clauses or sub-clauses to be audited, if a
partial audit is identified
Include schedules and/or frequency for planned audits. The
time period for the full QMS shall not exceed 3 years.
2.2. When the risk cause is
identified as a process, the plan shall identify Process Review
and/or Product Examination as a part of surveillance
methodology.
2.2.1. The process review portion of the surveillance plan shall include
the type of Process Review (Single Event or Incremental), frequency,
schedule, and identification of the process outputs to be
verified.
2.2.2. Production rates shall be considered when establishing the
frequency for recurring Process Reviews. Process Reviews shall
be scheduled at intervals of no greater than one year
when:
The process is associated with a high impact risk statement
2.2.3. When the likelihood rating is moderate or high, or Process
Review is the only selected surveillance method the frequency
shall be commensurate with the risk but as a minimum accomplished
semiannually.
2.3. When the Risk Cause is
identified as a product characteristic or feature, the plan shall
include Product Examination as part of surveillance
methodology.
2.3.1. Product
Examination should be planned and performed as early in the product
realization process as practicable. The higher the performance
risk (likelihood) the greater the benefit of early product
examination.
2.3.2. The surveillance plan shall identify the specific
characteristics to be verified or reference a supplemental document
that identifies the specific characteristics. The plan shall
also identify the intensity and frequency of planned product
examinations. All three elements are subject to
change based on subsequent analyses and risk assessment.
Multiple characteristics of the same product may be verified using
product examinations with different frequencies and intensities.
2.4. The surveillance plan shall
include the plan for Data Collection
and Analysis. As a minimum the plan shall address:
Data to be collected
Frequency of collection
Method of analysis
Frequency of analysis
3.Document the plan - QA personnel shall
document the GCQA surveillance plan. The plan portion of the Risk
Profile and Plan may be used. The
GCQA surveillance plan shall include as applicable:
Supplier Name, CAGE, & Address
Supplier point of contact
Name of QA Personnel
Indication of Facility Wide plan
Program name (for Program plan)
Contract number (for Contract specific plan)
Highest Level Quality Management/Inspection System
(AS9100C, ISO-9001:2008, Standard Inspection, etc.)
Facility Process List
Risk Statements and their associated risk impact rating
Risk Causes and their associated risk likelihood ratings
5. Update the plan - QA personnel shall update the GCQA surveillance plan due to
changes in risk. Updates may be based on a single risk
event as described during Risk
Assessment or on the results of Data Collection
and Analysis.