AS9100 - Product Safety

AS9100:2016 states

8.1.3 Product Safety
The organization shall plan, implement, and control the processes needed to assure product safety during the entire product life cycle, as appropriate to the organization and the product.

NOTE: Examples of these processes include:
− assessment of hazards and management of associated risks (see 8.1.1);
− management of safety critical items;
− analysis and reporting of occurred events affecting safety;
− communication of these events and training of persons.

If you're like most AS9100 companies, this requirement appears ambiguous/vague. That's because it is. And the “Note” is so nebulous that it is almost worthless. Sadly, there are a few articles, posts, and videos on the Internet from uninformed or poorly informed consultants confidently stating what they think “product safety” means. A couple of them are laughable.

The term “product safety” is confusing to many… because “safety” is often associated with “the state of being safe; freedom from the occurrence or risk of injury, danger, or loss.” While that is the most common definition, merriam-webster.com defines “safety” as:

safety
the condition of being safe from undergoing or causing hurt, injury, or loss.

That is how most people would interpret the word. However, AS9100 provides a different definition:

3.4 Product Safety
The state in which a product is able to perform to its designed or intended purpose without causing unacceptable risk of harm to persons or damage to property.

AS9120:2016 (for distributors) contains a similar definition:

3.6 Product Safety
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.

The above definitions provide much more clarity. But if we read “Product Safety” as “Product Integrity”, that makes it's meaning more easily understood.

I searched the definitions of 14 CFR and glossaries of the below organizations attempting to find any other use of the term. I found none.

14 CFR (Chapter I - Federal Aviation Administration) § 5.5 - Definitions

14 CFR (Chapter III - Commercial Space Transportation) § 401.5 - Definitions

ASQ "Quality Glossary"

Defense Acquisition University (DAU) "Glossary of Defense Acquisition Acronyms and Terms"

International Electrotechnical Commission Glossary

Consequently, it appears that “Product Safety” is a non-standard term created (invented) by IAQG.

While I ordinarily don't like to reference regulatory requirements, this is one of those instances where the regulatory requirements are more clear… and make sense.

14 CFR § 25.603 - Materials
The suitability and durability of materials used for parts, the failure of which could adversely affect safety, must -
(a) Be established on the basis of experience or tests;
(b) Conform to approved specifications (such as industry or military specifications, or Technical Standard Orders) that ensure their having the strength and other properties assumed in the design data; and
(c) Take into account the effects of environmental conditions, such as temperature and humidity, expected in service.

and

14 CFR § 25.605 - Fabrication methods
(a) The methods of fabrication used must produce a consistently sound structure. If a fabrication process (such as gluing, spot welding, or heat treating) requires close control to reach this objective, the process must be performed under an approved process specification.
(b) Each new aircraft fabrication method must be substantiated by a test program.

Upon reading “14 CFR § 25.603 - Materials”, we see how product safety begins with Engineering (8.3) selecting and specifying materials that are validated (8.3.4). These material requirements are then communicated to procurement (8.4) with consideration for “product safety” continuing through the value stream (with 14 CFR § 25.605 - Fabrication methods).

While AS9100 makes NO MENTION of product safety in all of section 8.3 (which it should), this section does require:

8.3.5 Design and Development Outputs
The organization shall ensure that design and development outputs:
e. specify, as applicable, any critical items, including any key characteristics, and specific actions to be taken for these items;

First… do the words “as applicable” actually change anything about the above requirement?

A “Critical Item” is defined in AS9100 as:

3.2 Critical Items
Those items (e.g., functions, parts, software, characteristics, processes) having significant effect on the provision and use of the products and services; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they are adequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc.

This is an extremely poor approach toward addressing such an important topic.

While the vast majority of AS9100 companies I've audited report NEVER having seen ANY item identified from the “Design Responsible” organization as a “Critical Item”, it remains the responsibility of the supplier to conform with AS9100, sec. 8.1.3 whether ANY items are identified as a “Critical Item” or not.

Due to civil liability issues, the vast majority of AS9100 auditors (and CBs) would not reference one of these regulatory requirements in a nonconformity, but instead, would cite a nonconformance with AS9100, sec. 8.1.3.

What "Specifically" does AS9100 require regarding "Product Safety"?

Let's assume that some design-responsible company has identified one or more “critical items”. What must be done?

7.3 Awareness
The organization shall ensure that persons doing work under the organization’s control are aware of:
g. their contribution to product safety;

Note that there is no requirement for there to be ANY records of the above requirement. So it must be confirmed through interviews.

8.4.2 Type and Extent of Control
When external provider test reports are utilized to verify externally provided products, the organization shall implement a process to evaluate the data in the test reports to confirm that the product meets requirements. When a customer or organization has identified raw material as a significant operational risk (e.g., critical items), the organization shall implement a process to validate the accuracy of test reports.

8.4.3 Information for External Providers
The organization shall communicate to external providers its requirements for:
h. special requirements, critical items, or key characteristics;
m. ensuring that persons are aware of:
− their contribution to product safety;

8.5.1 Control of Production and Service Provision
The organization shall implement production and service provision under controlled conditions.

Controlled conditions shall include, as applicable:
k. the control and monitoring of identified critical items, including key characteristics, in accordance with established processes;

What should you "really" do to address "Product Safety"?

AS9100 is so poorly written that IAQG should be embarrassed. So let's forget about AS9100 and just focus on doing “the right thing”.

Walter Sam O’Connor, Vice President - Technical Services for the Aviation Suppliers Association (ASA), provides a presentation on how to ensure “product safety” (focusing on AS9100/AS9110/AS9120): Product Safety as it applies to AS9100D/AS9110C/AS9120B

In his presentation, Mr. O’Connor identifies several good ideas… applicable to ANY “good” quality management system (regardless of “product safety”). In effect, Mr. O’Connor is politely “pointing out” some of the many inherent flaws in AS 9100 as a QMS standard rather than differentiate “product safety” from “product quality”. He builds his examples around the 6 Ms (which was a GREAT idea) and promotes Lean Six Sigma (also a GREAT idea).

It is a bit more challenging to identify specific actions that go above and beyond normal activities necessary to address the special considerations for “product safety”. Which, if you haven't figured it out yet, “really” apply to anything identified as a “Critical Item”. However, here are a few:

  • Increase the measurement accuracy ratio between the measuring instrument used and the tolerance of the part. For example, if you normally maintain a Measurement Ratio nf 4:1, then increase that ratio to 10:1 in order to reduce the risk of that part being out of tolerance.
  • Add inspection points (e.g., human or automated, using different techniques) to enhance verification that the product conforms to its requirements.
  • Add “call-outs” in drawings, Work Instruction, procedures, etc. to emphasize any critical characteristics.
  • Require greater control over any material or process supplier (beyond normal requirements). For example, require the supplier to create and maintain a PFMEA for that process.
  • Obtaining and monitoring the process capability (i.e., Cp, Cpk) and/or process performance (i.e., Pp, Ppk) data related to each process producing each Critical Item.
  • If you have an Engineering function, download and adopt the applicable requirements of MIL-STD 882, "System Safety". MIL-STD 882 requires a more detailed risk assessment for “product safety”; one that AS9100 should have required.