Double Spec'ing in Control Plans

R

redman5

#1
I have been looking over control plan templates and I have a concern based on what I am seeing in the templates.

Why would you put the product specification on a control plan. This is controlled by the print (product related) and the procedure (process related). This seems to be creating opportunity for the system to be out of compliance. i.e. if I am controlling a weld, the weld strength is specified on the drawing. The control plan should list what you are going to control and how. Basically the Control Plan is not a stand alone document and the drawing and procedure should be used in conjunction with the control plan. Also the templates called out the SOP to be used to perform the controlling action. The SOP is called out in the operating procedure, again this is double spec'ing. IMHO
 
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Jim Wynne

Staff member
Admin
#2
I have been looking over control plan templates and I have a concern based on what I am seeing in the templates.

Why would you put the product specification on a control plan. This is controlled by the print (product related) and the procedure (process related). This seems to be creating opportunity for the system to be out of compliance. i.e. if I am controlling a weld, the weld strength is specified on the drawing. The control plan should list what you are going to control and how. Basically the Control Plan is not a stand alone document and the drawing and procedure should be used in conjunction with the control plan. Also the templates called out the SOP to be used to perform the controlling action. The SOP is called out in the operating procedure, again this is double spec'ing. IMHO
If you're doing automotive work, the control plan is supposed to be a "master" document. It may or may not be actually used in production. If it's not, it serves as a sort of record of the process control requirements. If you use some other form of control documents in production, such as drawings, routers, work instructions, etc., there is indeed a duplication involved, but there usually isn't much of a way of getting around it. You need to make sure the control plan stays in sync with what's actually being done.

If you're not doing automotive work, or if you don't have any customer requirements relative to the structure of the control plan (or even the existence of them) you can pretty much do what you want.
 
R

redman5

#3
Thanks, I am involved in Class III medical devices and I am not well versed in other industries quality systems. You are right, in my experience in most medical companies the drawing and the procedure are the controlling document for the output in production. I see the PFEMA and the Design Controls to be part of the DHF to make sure that all known failure modes are identified and that appropriate controls are addressed.
 

Jim Wynne

Staff member
Admin
#4
Thanks, I am involved in Class III medical devices and I am not well versed in other industries quality systems. You are right, in my experience in most medical companies the drawing and the procedure are the controlling document for the output in production. I see the PFEMA and the Design Controls to be part of the DHF to make sure that all known failure modes are identified and that appropriate controls are addressed.
I'm not familiar with medical device requirements or what's generally expected from customers, so let's see what some of our medical device experts have to say.
 

julsbear

Involved In Discussions
#5
I understand your concern with double specs. and the problems that may cause. As with other posters, I am not sure of the practice in medical devices, but this is usually required or suggested in automotive.

Also, the control limits used in production are not necessarily the spec limits; they may be the safety factor limits many firms apply to spec limits (another whole issue), or SPC calculated limits.

The SOP to measure, record and address the result may be anything but standard and may differ depending on whether the feature is deemed critical, significant or some other classification. It may also differ during the life cycle of the part or process. Providing the specific action here may be more effective than having to look it up in another document.

This apparent duplication is (other than stated in para 1) to provide as much information in one place as possible, especially if the CP is to be used at the production line.

If an auditor finds a CP w/o this information, they may question if someone is really going to obtain and find the information on the drawing or the operating process.

Hope this helps.
 
R

redman5

#6
Yeah that is my problem, my experience is that the CP is an engineering tool and not part of the production documentation, in other words we do not have the CP on the floor with the operator, therefore I see the controlling documents to be the drawing and procedures. The CP is more of a trace matrix to insure that the appropriate controls have been installed into the production documentation.
 

julsbear

Involved In Discussions
#7
Are the people on the production floor consistently able to know what to measure based on these documents? Are there forms (paper or electronic) that specify what, when, where and how to monitor the product and process? Do these spell out how to respond to problems?
 

julsbear

Involved In Discussions
#9
Then you are covered. It seems the automotive and Medical device governing bodies differ on the control plan.
 

Chennaiite

Never-say-die
Trusted Information Resource
#10
We are ISO/TS certified Automotive group. Believe me, our 'Control Plan' does not hold a conventional format. It is integrated with Work Instruction and used in the workstation, while also including information required for controlling the process and product as identified by FMEA. It serves as both 'Control Plan' and 'Work Instruction', so to speak.
Having said that, there can also be a situation where the need for Control plan as a separate document may exist. For instance, a Customer might be interested in looking at the Summary of controls, rather than getting into the instructions or checklists.
 
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