What will auditor ask? 8.2.3.1. Monitoring and Measurement of Manufacturing Processes

[xgisbert]

8.2.3.1. Monitoring and measurement manufacturing processes

Hello Collegues

Dealing with 8.2.3.1 Monitoring and measurement of manufacturing processes I have two deep doubts.

First One. May I expect to be aked, by the auditor, for capability studies for all my new manufacturing processes? If so, would it be enough to be apply capability studies for only special characteristics.

Second and last. Being my manufacturing process 'small batch orientated' (average production lead time of 5 hours), does it really make sense to do SPC for monitoring these manufacturing processes?

I would appreciate any light to this doubts. Thanks in advance.

 

[p_tww]

Hello Collegues

Dealing with 8.2.3.1 Monitoring and measurement of manufacturing processes I have two deep doubts.

First One. May I expect to be aked, by the auditor, for capability studies for all my new manufacturing processes? If so, would it be enough to be apply capability studies for only special characteristics.

Second and last. Being my manufacturing process 'small batch orientated' (average production lead time of 5 hours), does it really make sense to do SPC for monitoring these manufacturing processes?

I would appreciate any light to this doubts. Thanks in advance.

you should apply capability for special characteristics on all new processes, but only variable data could be studied at initial run, others such as attribute data would be studied after you discussion with customers.
2nd question: You should apply SPC in series production, although you have short processing time, you still need to shorten your subteam interval on control chart application to identify special cause in production, that's preventive control means.
Finally, if you do not know what's next step, consult your customers.
hope help

 

[bpritts]

XGISBERT,

you might want to consider variants of SPC designed for short run manufacturing. There are several good books I know of (all in English, I am afraid!) such as SPC Methods for Quality Improvement by Charles Quesenberry published by John Wiley & Sons. Caution: this book assumes a strong knowledge of statistics.

The general idea of short run SPC is that you use a single control chart for a process, regardless of what product is being run. To do this you need to transform the data before charting. Example: on a lathe you subtract the nominal diameter from the actual diameter measured. Your x bar chart is on the difference between nominal and actual (error).

This chart can be used regardless of which part you are running.

buena suerte,

Brad Pritts

 

[gpainter]

8.2.3 is dealing with the m/m of processes of the QMS best done thru internal audits and mgm. review.

 

[Marc]

8.2.3.1 Monitoring and measurement of manufacturing processes

The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria. The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified

- measurement techniques
- sampling plans
- acceptance criteria, and
- reaction plans when acceptance criteria are not met.

Significant process events, such as tool change or machine repair, shall be recorded.

The organization shall initiate a reaction plan from the control plan for characteristics that are either not statistically capable or are unstable. These reaction plans shall include containment of product and 100 % inspection as appropriate. A corrective action plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans shall be reviewed with and approved by the customer when so required. The organization shall maintain records of effective dates of process changes.

 

[Rachel]

Huh?

See, the ways I've interpreted this clause (and 8.2.4) are as follows:

8.2.3: "This is accomplished through the use of goals and targets for each department (i.e., monthly and year-to-date defect rates vs. target for the Packaging department). These processes are measured through the analysis of relevant data (i.e., defect counts), and monitored using internal audit processes."

8.2.4: "This is accomplished via comparison of actual product data to specifications (i.e., actual product viscosity vs. specification). Product conformance to requirements is tracked by analyzing product test results achieved at various stages of each process."

Am I on the right track here? Am I missing a huge chunk of stuff that should be incorporated into the mix?

 

[Sam]

See, the ways I've interpreted this clause (and 8.2.4) are as follows:

8.2.3: "This is accomplished through the use of goals and targets for each department (i.e., monthly and year-to-date defect rates vs. target for the Packaging department). These processes are measured through the analysis of relevant data (i.e., defect counts), and monitored using internal audit processes."

8.2.4: "This is accomplished via comparison of actual product data to specifications (i.e., actual product viscosity vs. specification). Product conformance to requirements is tracked by analyzing product test results achieved at various stages of each process."

Am I on the right track here? Am I missing a huge chunk of stuff that should be incorporated into the mix?

Right on track. . . . .(you probably should mention customer specific requirements) and each operator in each process MUST know how to interpret the information,e.g., charts, test data, and also be involved in the problem solving processes.

 

[Rachel]

Thanks, Sam - that's what I like to hear.
Makes me happy when I get something right. Sometimes it feels like I spend more time scratching my head than tapping the keyboard...

 

[Satellite]

See, the ways I've interpreted this clause (and 8.2.4) are as follows:

8.2.3: "This is accomplished through the use of goals and targets for each department (i.e., monthly and year-to-date defect rates vs. target for the Packaging department). These processes are measured through the analysis of relevant data (i.e., defect counts), and monitored using internal audit processes."

8.2.4: "This is accomplished via comparison of actual product data to specifications (i.e., actual product viscosity vs. specification). Product conformance to requirements is tracked by analyzing product test results achieved at various stages of each process."

Am I on the right track here? Am I missing a huge chunk of stuff that should be incorporated into the mix?

The way our CB addessed this is not by things you do every day in your process. These audits are in addition to the usual activities and are part of your internal audit process only. This is a verification of how your process works and how the product conforms at each step to verify the operation of the process.

For a basic process - Receive - machine - ship.
How effective was the receiving process at detecting incoming NC's? # of NC issued to suppliers, # caught at receiving, # caught at machining, # caught at customer. Lets use 100 supplier NC's over a year. 5 were caught at receiving, 25 at machining and 70 at the customer. How effective is receiving at catching NC's?

This IMO, what they are trying to drive to with auditing the process. You can have 100% part availability, 100% clearing the dock on time, but under sample and never find anything until it's too late.

 

[pinpin - 2009]

Re: What will auditor ask? 8.2.3.1. Monitoring and Measurement of Manufacturing Proce

8.2.3.1 Monitoring and measurement of manufacturing processes

The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications, where applicable, for means of production, measurement and test, and maintenance instructions. These documents shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria. The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified

- measurement techniques
- sampling plans
- acceptance criteria, and
- reaction plans when acceptance criteria are not met.

Significant process events, such as tool change or machine repair, shall be recorded.

The organization shall initiate a reaction plan from the control plan for characteristics that are either not statistically capable or are unstable. These reaction plans shall include containment of product and 100 % inspection as appropriate. A corrective action plan shall then be completed by the organization, indicating specific timing and assigned responsibilities to assure that the process becomes stable and capable. The plans shall be reviewed with and approved by the customer when so required. The organization shall maintain records of effective dates of process changes.

Dear Marc,

I joined Elsmar Cove late and have many questions to ask and learn.....

I read your above info but could not find your comment on those highlighted in red colors "process capability, reliability, maintainability and availability, as well as acceptance criteria". These are the things I need to know what they meant. Could you kindly explain what they meant and what to do to meet these requirements?

Thank you so much!