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--- articles:as9100d_product_safety [2020/08/03 21:18] – [AS9100 - Product Safety] rrandall
+++ articles:as9100d_product_safety [2022/03/18 07:00] (current) – [What should you "really" do to address "Product Safety"?] rrandall
@@ Line 17: / Line 17: @@
 the condition of being safe from undergoing or __causing__ hurt, injury, or loss.</blockquote>
-So let's look at the definition provided in AS9100 to see if that provides any greater clarity:
+That is how most people would interpret the word. However, AS9100 provides a __different__ definition:
 <blockquote>**3.4 Product Safety** \\
@@ Line 78: / Line 78: @@
 <note>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.</note>
-===== What "Specifically" should AS9100 Companies address "Product Safety"? =====
+===== 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?
@@ Line 107: / Line 107: @@
 ===== 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".
+AS9100 is so poorly written that IAQG should be embarrassed. And the presentation from the [[https://iaqg.org/|IAQG (International Aerospace Quality Group)]] [[https://iaqg.org/tools/scmh/|SCMH (Supply Chain Management Handbook)]] titled "SCMH-3.9.2-Product Safety Awareness Guidance" (Rev. B, Dated-29SEP2021) inappropriately expands the scope of AS9100 from //Quality// into //Safety// (which is a word not defined by IAQG or ISO, but is defined by IEC 8000-1:2010 as: "//freedom from unacceptable risk of physical injury or damage to the health of people or damage to property or the environment//")! To make "product safety" an all-encompassing requirement requires a broader view of the term. In reality, the primary responsibility for realization of a "safe" product resides with the Design/Engineering function (8.3). The manufacturing function can only verify that they manufacture the product in accordance with the requirements set forth by the Design/Engineering function (which is the definition of "quality"... as defined by ISO 9001:2015 as the "//degree to which a set of inherent characteristics of an object fulfills requirements//"). If the design of a product is flawed (unsafe), and manufacturing produces a product that conforms with the Engineering specifications, the manufacturing function typically has no knowledge of the design defect.
-- Walter Sam O’Connor, Vice President - Technical Services for the [[https://www.aviationsuppliers.org|Aviation Suppliers Association (ASA)]], provides a far superior explanation of how to ensure "product safety" (than AS9100) in his presentation:
+Walter Sam O’Connor, Vice President - Technical Services for the [[https://www.aviationsuppliers.org|Aviation Suppliers Association (ASA)]], provides a presentation on how to ensure "product safety" (focusing on AS9100/AS9110/AS9120):
 [[https://www.aviationsuppliers.org/ASA/files/ccLibraryFiles/Filename/000000001848/SamO'Connor-WorkshopF.pdf | Product Safety as it applies to AS9100D/AS9110C/AS9120B]]
- - If you have an Engineering function, download and adopt the applicable requirements of [[http://everyspec.com/MIL-STD/MIL-STD-0800-0899/MIL-STD-882E_41682/|MIL-STD 882, "System Safety"]].
+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 of 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 [[http://everyspec.com/MIL-STD/MIL-STD-0800-0899/MIL-STD-882E_41682/|MIL-STD 882, "System Safety"]]. MIL-STD 882 requires a more detailed risk assessment for "product safety"; one that AS9100 should have required.
-MIL-STD 882 requires a more detailed risk assessment for "product safety"; one that AS9100 should have required.