The document provides guidance on industry expectations for organizations certified to AS9120. It emphasizes that distributors must operate within the boundaries of procuring, storing and reselling parts. Auditors should follow audit trails and ensure the distributor focuses on customer requirements. Key expectations include reviewing requirements, identifying and mitigating risks in the supply chain, competency of personnel, preventing counterfeit parts, and flowing QPL requirements to sub-tier suppliers. The document directs readers to additional IAQG resources for more information.
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AS9120 expectations (2).ppt
1. Company Confidential 1
Industry Expectations
for Distributors
Aaron Gemeny
Boeing
Supplier Quality Representative
IAQG OP Assessor
July 22, 2016
2. AS9120 Intended Application
• This standard is intended for use by organizations that
procure parts, materials, and assemblies and resell
these products
• This standard is not intended for organizations that
maintain or repair products, or for organizations that
perform work that affect or could affect product
characteristics or conformity.
– The boundaries are clear
– The expectation is that Distributors work within the
boundaries of the Standard
2
Top management shall demonstrate leadership and
commitment with respect to customer focus by ensuring that:
3. AS9120 Intended Application
• Manufacturing or processing of any sort
• Direction to a supplier regarding methods to machine,
process, or manufacture
• Actual examples of AS9120 scope statement that
appear to be beyond applicability of the Standard
– ...with associated value add processes
– ...distributor and provider of added services for
aerospace materials
– ...and subsequent processing as required
Examples of work that falls outside the boundaries
3
4. Customer Focus
• customer and applicable statutory and regulatory
requirements are determined, understood, and
consistently met
– Robust Contract Review
– Competence in the subject
– Access to requirements and specifications
– Verification of product supplied to customers
4
Top management shall demonstrate leadership and
commitment with respect to customer focus by ensuring that:
5. Customer Focus
• the risks and opportunities that can affect conformity
of products and services and the ability to enhance
customer satisfaction are determined and addressed;
– Risk identification
» Visibility into the supply chain
» GIDEP alerts
– Risk mitigation
» Action plans and follow up
5
Top management shall demonstrate leadership and
commitment with respect to customer focus by ensuring that:
6. Customer Focus
• the focus on enhancing customer satisfaction is
maintained;
• product and service conformity and on-time delivery
performance are measured and appropriate action is
taken if planned results are not, or will not be,
achieved.
– Review of customer scorecards during Management
Review
– Communication of performance to customer
requirements throughout the organization
– Robust Improvement plans
6
Top management shall demonstrate leadership and
commitment with respect to customer focus by ensuring that:
7. Competence
• determine the necessary competence of person(s)
doing work under its control that affects the
performance and effectiveness of the quality
management system;
– Understand the needs of your business
– Evaluate each process and its requirements and
interactions
7
The organization shall:
8. Competence
• ensure that these persons are competent on the basis
of appropriate education, training, or experience;
• where applicable, take actions to acquire the
necessary competence, and evaluate the effectiveness
of the actions taken
– Assure that personnel have the skills to effectively do the
job
– Continually evaluate and assure skills are keeping pace
with Industry!
8
The organization shall:
9. Prevention of Counterfeit Parts
• Counterfeit Parts are considered a significant risk in
the Industry
• Additional requirements flow down could include
AS5553 Fraudulent/Counterfeit Parts; Avoidance,
Detection, Mitigation, and Disposition
• AS9120 includes a note on risks that the
organization’s counterfeit prevention process “should”
consider
9
The organization shall plan, implement, and control processes,
appropriate to the organization and the product, for the
prevention of counterfeit or suspect counterfeit part use and their
inclusion in product(s) delivered to the customer.
10. Prevention of Counterfeit Parts
– training of appropriate persons in the awareness and
prevention of counterfeit parts;
– application of a parts obsolescence monitoring program;
– controls for acquiring externally provided product from
original or authorized manufacturers, authorized
distributors, or other approved sources;
– requirements for assuring traceability of parts and
components to their original or authorized
manufacturers;
– verification and test methodologies to detect counterfeit
parts;
– monitoring of counterfeit parts reporting from external
sources;
– quarantine and reporting of suspect or detected
counterfeit parts.
10
NOTE: Counterfeit part prevention processes should consider:
11. Prevention of Suspected
Unapproved Parts
11
The organization shall plan, implement, and control a process
appropriate to the organization and the product that identifies and
prevents the release of unapproved and suspected unapproved
parts.
Counterfeit Part
An unauthorized copy, imitation, substitute, or modified part (e.g.,
material, part, component), which is knowingly misrepresented as
a specified genuine part of an original or authorized
manufacturer.
Unapproved Part
A part that was not produced or maintained in accordance with
approved or acceptable data and applicable statutory, regulatory,
and customer requirements.
12. Prevention of Suspected
Unapproved Parts
– training of appropriate persons in the awareness and
identification of suspected unapproved parts;
– requirements for assuring traceability of parts and
components to an authorized source;
– inspection processes to detect suspected unapproved
parts;
– monitoring of suspected unapproved parts reporting from
external sources;
– quarantine and reporting of suspected unapproved parts
in accordance with applicable requirements from the
competent authority or customers, as required.
• Auditors are expected to follow the audit trails
regarding the traceability of parts to an authorized
source
• Review training program for prevention of suspected
unapproved parts to assure compliance 12
Suspected unapproved parts prevention processes should consider:
13. Review of the Requirements for
Products and Services
– requirements specified by the customer, including the
requirements for delivery and post-delivery activities;
– statutory and regulatory requirements applicable to the
products and services;
• This review shall be coordinated with applicable
functions of the organization.
– Robust Contract Review
– Competence in the subject
– Access to requirements and specifications
13
The organization shall ensure that it has the ability to meet the
requirements for products and services to be offered to customers. The
organization shall conduct a review before committing to supply products
and services to the customer, to include:
14. Review of the Requirements for
Products and Services
• Example of NCR issued to CB
– CB Client (Distributor - ACME Chemicals) is not
reviewing qualified products lists (QPLs) when issuing
purchase contracts to its suppliers. The Client is relying
on its suppliers to review the QPL and be listed on the
QPL without verification by the Client. The CB auditor
followed the audit trail; however, did not issue a NCR.
The lack of QPL review during the purchasing processes
is a nonconformance related to the requirements of
AS9120A clause 7.2.2 Review of Requirements related to
the Product and 7.4.3 Verification of Purchased Product
14
The organization shall ensure that it has the ability to meet the
requirements for products and services to be offered to customers. The
organization shall conduct a review before committing to supply products
and services to the customer, to include:
15. Control of Externally Provided
Processes, Products, and Services
• The organization shall be responsible for the
conformity of all externally provided processes,
products, and services, including from sources defined
by the customer.
• The organization shall identify and manage the risks
associated with the external provision of processes,
products, and services, as well as the selection and
use of external providers.
– The Distributor is responsible for the products procured
and provided to its customer
– The Distributor is expected to identify and mitigate risks
15
The organization shall ensure that externally provided processes,
products, and services conform to requirements.
16. • maintain a register of its external providers that
includes approval status (e.g., approved, conditional,
disapproved) and the scope of the approval (e.g.,
product type, process family, authorized approval to
distribute);
• periodically review external provider performance
including process, product and service conformity, and
on-time delivery performance;
– Identifying and evaluating risk
• define the necessary actions to take when dealing
with external providers that do not meet
requirements;
– Risk mitigation by taking action to improve the
performance of its supply base
16
Control of Externally Provided
Processes, Products, and Services
The organization shall
17. • the potential impact of the externally provided
processes, products, and services on the
organization’s ability to consistently meet customer
and applicable statutory and regulatory requirements;
• the effectiveness of the controls applied by the
external provider;
• the results of the periodic review of external provider
performance
– Recurring theme of identifying risk and taking action to
mitigate risk
17
Type and Extent of Control
take into consideration:
18. • the expectation is that is more than a review of the
Certificate of Conformance
• the standard requires inspection or testing to mitigate
any identified high risks
– Distributor verification activities should be appropriate to
the product and product risk.
– Remember, the distributor is responsible for compliance
to the contract.
– Ask the Distributor how their organization identifies a
high risk
– The Distributor should be able to provide evidence of
inspection or testing to mitigate high risks
18
Type and Extent of Control
Verification activities of externally provided processes, products,
and services shall be performed according to the risks identified
by the organization. These shall include inspection or periodic
testing, as applicable, when there is high risk of nonconformities
including counterfeit parts.
19. • the expectation is that QPL requirements are flowed to
sub-tiers
• Notification of nonconformances are communicated up
through the supply chain including NoEs for delivered
product
19
Information for External
Providers
The organization shall ensure the adequacy of requirements prior to their
communication to the external provider.
The organization shall communicate to external providers its requirements
for: the processes, products, and services to be provided including the
identification of relevant technical data (e.g., specifications, drawings,
process requirements, work instructions);
the need to: use customer-designated or approved external providers,
including process sources (e.g., special processes);
notify the organization of nonconforming processes, products, or services
and obtain approval for their disposition;
prevent the use of suspected unapproved, unapproved, and counterfeit
parts
20. • Does 9120 allow for a distributor to contract/outsource the manufacturing
of product to an external provider?
– When a distributor takes on selection of a manufacturing source or outsources the manufacturing
themselves, they have taken on control of the manufacturing process, and as such, are inherently adding
value – this is outside of the scope of 9120.
– Distributors may coordinate regulatory controlled processes (e.g. repair/overhaul from regulatory-
approved repair stations), or may coordinate customer-designated processes from approved sources (e.g.
special processes) – this is within the scope of 9120.
• What constitutes ‘splitting’ within the context of 9120:2016? (3.7)
– 9120:2016 defines splitting as “The division of product either physically or by batch quantity, without
affecting the product characteristics or conformity.” The issue that comes up often is the word
“physically” which draws some question about what limits of work may be performed on a product which
is why the qualifier was added that product conformity or characteristics were not to be affected during
any splitting operations. The terms of doing “kitting” or the process of taking large batches of products
and breaking them down into smaller shipping quantities is the traditional role of a Distributor.
– In practical terms there is an example of a raw material provider that may have large lengths or bar or
sheet or tube of materials from a mill; or a provider of liquids or adhesives that are delivered in large
containers; or of wire where the manufacturer provides large spools of product. Customers may desire
smaller quantities than what is on hand, so the Distributor may ‘cut, saw or other method (but not a
special process)’ to divide the product into smaller units which will not affect the material’s conformity or
product characteristics.
20
Guidance provided by the IAQG
Questions relating to specific clauses in the standard
21. • Is Design and Development “applicable” to Distributors in 9120:2016?
(8.3)
– ISO 9001:2015 has changed so that it would be inclusive of service oriented organizations. Since
Distributors could be a “service provider” beyond just the providing of products to customers, it may be
appropriate for an organization to include this clause (see question 15 above). Distributors may have
services that they “design and develop” for customers, hence the expectation would be evidence of
compliance from the aspect of the distributor’s delivery of that service. This can be dependent on the size
and type of services a distributor provides. The applicability of 8.3 is dependent on the complexity of the
services a distributor provides to the customer. Refer to ISO 9001: 2015 Annex A.5.
• What is meant by the “consequences of obsolescence” (8.5.1)?
– For the purpose of this of the Standard, "consequences of obsolescence” requires the distributor to
consider the obsolescence of their inventory (e.g. shelf-life expired product, one-way interchangeable part
numbers, product revision/configuration levels, beyond cure-date limits for packaging materials) and the
consequences these scenarios could have if unintended use or sale occurs. For example, a means of
demonstrating control of obsolescence includes; maintaining batch/lot control, labeling protocols, shelf-life
control processes, inventory cycle-audit processes.
• What does product safety mean in the 9120 standard (3.6)?
– Product safety is defined in 9120 section 3 as: “Maintaining the state of product so that it is able to
perform to its designed or intended purpose without causing unacceptable risk of harm to persons or
damage to property.”
– Product safety is included in the following clauses: 7.3 (awareness), 8.1 (operational planning and
control), 8.4.3 (information for external providers). Each of these clauses speaks to the organizational
responsibility to ensure employee awareness of maintaining the product in a condition so as not to affect
adverse harm to persons using the product and any potential harm that could occur during the product’s
use. (e.g. ESD, FOD, shelf-life controls, storage and handling conditions).
21
Guidance provided by the IAQG
Questions relating to specific clauses in the standard
22. • Follow the audit trails
• Assure that the boundaries of the AS9120 certification
are respected
• Keep customer focus in mind
– Review of customer scorecards / metrics
– Verification of product supplied to customers
• The Distributor must conduct a thorough Review of
Requirements
– Robust contract review
– Access to requirements and specifications
• Assure that distributor personnel have the required
competency in their field
22
Summary of Expectations
23. • Focus on Prevention of Counterfeit Parts
• The Distributor is expected to identify and mitigate
risks in their supply chain
– Ask the Distributor how their organization identifies a
high risk
– They should be able to provide evidence of inspection or
testing to mitigate high risks
• QPL requirements need to be flowed to sub-tier
suppliers
• No soft grading
• Follow the guidance provided by the IAQG
23
Summary of Expectations
24. IAQG - http://www.sae.org/iaqg/
AAQG - http://www.sae.org/aaqg/
SCMH - http://www.sae.org/iaqg/
FAQ -
http://www.sae.org/iaqg/organization/9120.htm
Sector Document Representative -
http://www.sae.org/iaqg/organization/9120.htm
24
Where to go to get additional
Information