Mentioning Special Characteristics in SOP

Casana

Blueberry Nut
#1
It was identified during an internal audit that our procedures are not compliant with IATF 16949 8.3.3.3 requirements regarding special characteristics… specifically the procedures do not identify them directly. For reference, here’s a snip from the standard:

"The organization shall use a multidisciplinary approach to establish. document, and implement its process(es) to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization, and shall include the following:
  1. documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), control plans, and standard work/operator instructions; special characteristics are identified with specific markings and are cascaded through each of these documents;"
All I can come up with is maybe including a line item in the WI stating that Special Characteristic X is affected by this procedure… will that do?
How are others documenting this requirement?
 
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John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#2
It was identified during an internal audit that our procedures are not compliant with IATF 16949 8.3.3.3 requirements regarding special characteristics… specifically the procedures do not identify them directly. For reference, here’s a snip from the standard:

"The organization shall use a multidisciplinary approach to establish. document, and implement its process(es) to identify special characteristics, including those determined by the customer and the risk analysis performed by the organization, and shall include the following:
  1. documentation of all special characteristics in the drawings (as required), risk analysis (such as FMEA), control plans, and standard work/operator instructions; special characteristics are identified with specific markings and are cascaded through each of these documents;"
All I can come up with is maybe including a line item in the WI stating that Special Characteristic X is affected by this procedure… will that do?
How are others documenting this requirement?
Good day @Casana ;
Are you SURE your organization does not identify special characteristics? Since you reference IATF 16949 , I'm going to assume your organization is certified. What about in your control plans? How is that information carried to point of work? (i.e. how is the associate and supervision made aware so that there is an opportunity for them to escalate properly/uniquely when there is a problem related to a special characteristic?

However, your organization chooses to do this, don't do it in a manner that simply satisfies an 'audit". Do it in a manner that is sustainable and BENEFITS your organization. Be selfish.

Hope this helps.
Be well
 

Sebastian

Trusted Information Resource
#3
Not going into much details, let's take an example.
Internal diameter 50 is a special characteristic.
It is identified with "!" symbol in certain PFMEA and control plan lines.
In control plan column "Control method" within line for internal diameter 50, you have reference to work instruction used for inspection of this characteristic.
This work instruction has to have "!" symbol next to area where wording "internal diameter 50" is.

In rare cases, when company has know how and ability to match product characteristic with process characteristic, it can identify also process characteristic with "!" symbol.
In this case it could be tool external diameter 50.
Tool capability to produce good parts is controlled through maintenance.
One of inspection items within maintenance standard is measuring this external diameter.
This maintenance standard has to have "!" symbol next to area where wording "external diameter 50" is.

Purpose is make staff aware of some items more important than others and send a message "hey look, there is "!" symbol in document, it is special characteristic, stay focused."
 

Casana

Blueberry Nut
#4
Thanks for all the comments!

John C. Abnet – yes, you are correct that we already include the SC in the PFMEA & the CP. What was confusing me was the need to *also* include it in the Work Instructions.

Sebastian- thanks for clarifying the requirement in your comments. I’ll have to think on how to implement since (to be honest) I see absolutely no value to including a “!” in the work instructions for our product other than paperwork and making the auditor happy. I can tell you the operators are going to ignore it b/c they are going to follow the WI the same way whether there is a ! there or not.
But your comments will help in doing that at least! :LOL:
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#5
John C. Abnet – yes, you are correct that we already include the SC in the PFMEA & the CP. What was confusing me was the need to *also* include it in the Work Instructions.
The purpose is to ensure that the special characteristic is identified at the point of work. If it is only in the "office" documentation, then what will cause the team on the production floor to recognize any potential unique requirements of those with "special characteristics" ? How will the team on the floor be aware if they are not identified at point of work?

Let's switch gears and talk about 4.4.1.2 Product Safety for a bit. It is common for characteristics related to product safety to ALSO have a special characteristic applied. Product Safety 'likewise" has a requirement for, (as applicable) for ..identification and controls at the point of work" . How does your organization currently manage that? I found that there is usually overlap, and, therefore, instead of creating new/separate approaches...a common approach often works well.

The point in all of this is that the production floor can not initiate any specially required controls, actions, escalation, etc...unless THEY are aware. Food for thought.

Hope this helps.
Be well.
 
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