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Control of Nonconforming Outputs Guidance: SCMH Section 3.3.2
Control of Nonconforming Outputs Guidance: SCMH Section 3.3.2
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2. Scope
2.1. Guidance for the nonconformity management process elements of root cause
corrective action and counterfeit parts are not addressed within this document.
Those topics are addressed separately in other sections of the SCMH.
2.2. Use of the term “articles” can be extended to mean materials, products,
processes or services.
2.3. This guidance is intended only for production articles, not for articles intended for
modification or replacement of in-service articles.
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SCMH Section 3.3.2
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3. Document Content
3.1. The content of this document in Sections 5 – 14 is structured around (10) themes
contained within AS/EN/JISQ 9100:2016 Section 8.7. These themes are all
elements pertaining to the control of nonconforming articles and have been
identified as:
• Identification of Nonconforming Articles
• Segregation of Nonconforming Articles
• Containment of Nonconforming Articles
• Records of Nonconforming Articles
• Disposition of Nonconforming Articles
• Customer Approvals of Nonconforming Articles
• Execution of Nonconforming Article Dispositions
• Verification of Corrected Nonconforming Articles
• Customer Notification of Escaped Nonconforming Articles
• Scrap of Nonconforming Articles
3.2. This key icon identifies content that provides clarification of specific content
of AS/EN/JISQ 9100:2016 or of new approaches associated with the control of
nonconforming articles.
3.3. While every attempt has been made to state this guidance in a manner that
makes it applicable to the aviation, space and defense industries, any industry
unique guidance is clearly noted.
3.4. To complement this guidance, examples of nonconforming article control “Best
Practices” that support the implementation of the requirements of AS/EN/JISQ
9100:2016 are available at http://www.iaqg.org/scmh.
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5.1. Utilize proper inspection points, tests, inspection standards, applicable design
data and competent operators in the production process to recognize
nonconforming articles.
5.2. Identify the nonconforming articles to clearly distinguish them from conforming
articles. Identification is typically done with paper or metal tags, stickers or tape
that does not damage or contaminate the article. When physical identification of
the nonconforming article is not practical, it should be possible to locate the
nonconforming condition utilizing the nonconformity record or work authorization
document. A clearly described location of the nonconformity on the
nonconformity record greatly aids in identification.
5.3. Identify where the nonconforming article is within the sequence of production
operations in order to continue processing upon resolution of the nonconformity
or for proper sequencing of rework or repair work instructions.
5.4. Ensure that the nonconformity management system, including organizational or
individual roles, responsibilities and nonconformity processing requirements, is
documented in the quality management system.
5.5. Identify articles that are potentially nonconforming while an investigation
proceeds to determine if they are actually nonconforming. In situations where
potential nonconforming articles are being investigated, identify those articles in
an interim manner until a determination is made whether a nonconformity is
present.
5.6. Identify articles being shipped to customers with unresolved (open)
nonconformities with tagging or marking of the nonconforming article as specified
by contract. Shipping containers may also be appropriately tagged or marked.
5.7. Review process and approval of noncompliance issues such as unqualified
processors, loss of Nadcap accreditation, quality system failures/suspension, etc.
to determine whether nonconforming articles resulted from these noncompliance
issues.
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nonconforming articles and the process for approving persons making these
decisions. Ensure that any requirements, restrictions, or limitations imposed by the
customer are met.
9.2.1. Document the responsibility and authority for the review and disposition of
nonconforming articles with dispositions of use-as-is or repair, and the
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9.3.1. Suppliers that do not hold an article design approval (e.g. a TC, ATC,
STC or TSO/JTSO/ETSO or equivalent) from a regulatory authority must
receive an explicit delegation for material review disposition authority from
the design organization. Material review authority can only come from the
TC, ATC, STC or TSO/JTSO/ETSO holder for commercial programs and
from the defense or space contractor.
9.3.1.1. There is a common misunderstanding by suppliers performing
design of the following statement from AS9100D section 8.7:
“Dispositions of use-as-is or repair for the acceptance of
nonconforming products shall only be implemented after approval
by an authorized representative of the organization responsible
for design or by persons having delegated authority from the
design organization.” This confusion normally is caused by a
misunderstanding of who is the ‘organization responsible for
design’ and ‘design organization’ specified by AS/EN/JISQ
9100D.
9.3.1.2. The identity of the “design organization” is clarified by referring to
the IAQG Dictionary definition of design organization (DO) as “An
organization responsible for the design of articles or for changes
thereto that is the holder of a Design Approval granted by a
regulatory authority i.e. TC, STC, PMA, or TSO/JTSO/ETSO
Authorization, or equivalent.”
9.3.2. While material review is a component of both the customer and
supplier quality management systems which are generally a responsibility
of the quality organization, both the delegation of authority and execution
of material review dispositions are engineering-centric activities. The
customer’s engineering organization should have a role in the evaluation,
delegation and oversight of the supplier’s delegated engineering authority
with the focus being upon assuring the supplier is providing use-as-is and
repair dispositions that meet all design and regulatory technical
requirements. Correspondingly, since it is typical that the supplier
authorized individuals providing material review dispositions report to an
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10.1. Establish a means to identify the customer of the nonconforming article and
determine customer requirements for disposition or disposition approval.
10.2. Suppliers without delegated material review authority must obtain material
review dispositions from authorized individuals at the customer. This includes
reoccurring or similar nonconformities previously dispositioned by the customer.
10.3. Suppliers with delegated material review authority must contact the customer
for approval of dispositions when required by contract. Customers that are the
design approval holder or other authorized representatives (e.g. Government
Quality Assurance Representative – GQAR) reserve the right to reject a
supplier’s disposition.
10.4. Include proposed dispositions along with a detailed description of the
nonconformity in customer submittals.
10.5. Customer approval is not required for preliminary review dispositions; however,
notification may be required for scrap dispositions - typically on defense or
space programs or customer or other supplier-owned articles.
10.6. Suppliers of standards and raw material need to submit nonconformity records
to customers for disposition. Material review delegation is usually not offered to
these suppliers.
10.7. Submit nonconformities classified as major or critical to customer for
disposition.
10.8. Submit nonconformities to the customer per contractual requirements. Note:
violations of customer requirements classified as a “major” nonconformity by
the provider may be re-classified by the design approval holder.
10.9. When a supplier has a need to ship hardware to the customer with an open
nonconformity, a written authorization to ship must be coordinated and
processed through the customer for approval.
10.10. Following customer approval of a nonconformity disposition, any changes to the
disposition must be resubmitted for customer approval.
11.1. Ensure that personnel performing work are qualified and hold any necessary
certifications.
11.2. Perform the disposition according to the nonconformity record or work
authorization document.
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13.1. The scope of escaped nonconforming articles is typically an output from the
containment action.
13.2. Follow contract requirements for customer notification of escaped
nonconforming articles. Notify the customer that issued the purchase order,
which may be different than the ship-to company/location.
13.3. Customers may consider offering latitude in contract requirements for the timing
of notification to allow proper scoping and evaluation of the escapement unless
there is a safety concern. Customers should require immediate notification of
safety concerns.
13.4. Maintain a company policy for managing escapements including flow down of
requirements to sub-tier suppliers.
13.5. With customer approval and evaluation criteria, suppliers may be able to
evaluate escaped articles to differentiate articles that require recall versus
escaped articles that only require customer notification or may not require
customer notification due to no adverse impact on escaped article function (e.g.
use-as-is disposition). Escaped articles may be managed entirely within the
supplier’s QMS if there is no downstream impact.
13.5.1. Generally, articles that have left the supplier QMS are not to be
dispositioned by the supplier and require customer notification. With an
expanded authority granted by the customer, the ability to disposition
escaped articles within the supplier QMS rather than the customer QMS
for no impact (use-as-is) escapements is due to the supplier QMS,
when approved by the customer, becomes an extension of the
customer’s QMS. Explicit delegation specific to this authority including
any limitations or any communication requirements when exercising this
authority is needed.
13.5.2. Due to the sensitive nature and risk associated with escaped articles,
suppliers under consideration for expanded use-as-is disposition
authority for escapements should have a mature and stable QMS and
have demonstrated technical competency in material review decisions.
Additional supplier controls are advised such as mandatory customer
coordination by the supplier, immediate submittal of completed records
for customer review, etc.
13.5.3. Nonconforming articles that are determined to be use-as-is that have
been delivered by the customer and are in-service are beyond the
scope of the customer’s QMS and need to be addressed by a separate
means specified by the customer.
13.6. Reporting of in-service failures of products or articles is a responsibility of the
defense or space contractor or the design approval holder and is not delegated.
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SCMH Section 3.3.2
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15. References
The following documents were consulted for the development of the nonconforming
article control guidance contained within this document.
Aviation
ARP/EN/SJAC 9136 - Aerospace Series - Root Cause Analysis and Problem Solving
AS9100 Section 7.4 - Communication
AS/EN/SJAC 9131C - Aerospace Series - Quality Management Systems -
Nonconformance Data Definition and Documentation
China Civil Aviation Administration AP21-AA-2010-04R4– Production Approval and
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Space
Defense
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