Peters
22nd October 2008, 11:41 AM
"8.2.2.2 The organization shall audit each manufacturing process to determine its effectiveness"
1.How can we measure process effectiveness using process audit?
2.Are the nonconformities evidence of process ineffectiveness? Are the conformity to the requirements evidence of process effectiveness?
3.What audit statement can be evidence of process effectiveness or ineffectiveness (during the process audit)?
Can you help me?
Stijloor
22nd October 2008, 11:48 AM
"8.2.2.2 The organization shall audit each manufacturing process to determine its effectiveness"
1.How can we measure process effectiveness using process audit?
2.Are the nonconformities evidence of process ineffectiveness? Are the conformity to the requirements evidence of process effectiveness?
3.What audit statement can be evidence of process effectiveness or ineffectiveness in during the process audit?
Can you help me?
Simply said; effectiveness is the ability of the process to deliver "the goods."
If the (manufacturing) process is doing what it is supposed to do, you can call that process "effective." Smart organizations develop measureable objectives; these objectives are indeed measured and tracked over time.
Another way to look at this is that if the internal/external customer is pleased with the outcome of the process, the process is effective.
That's about it. Don't make a science ;) out of it.
Stijloor.
Duke Okes
22nd October 2008, 11:58 AM
These audits are often audits of the control plan ... walking the production line and evaluating whether or not the defined controls are actually being applied. Whether or not the specs are being met at each step of the process would evaluate effectiveness.
Peters
22nd October 2008, 04:37 PM
Stijloor
I think I don’t need process audit to know about
"is the (manufacturing) process doing what it is supposed to do"
I think I can get this information from the complaints, scrap, rework and Cpk
Duke Okes
"Whether or not the specs are being met at each step of the process would evaluate effectiveness"
Well… Isn’t it product audit realized on different stages of the production process?
Everybody
Definition of the Effectiveness – Extent to which planned activities are realized and planned results achieved.
Two questions result from this definition (concerning process effectiveness):
1.Do we realize planned activities such as control plan, flow-chart, instruction etc?
2.Do we achieve planned results like number of the complaints, scrap, rework, capacity etc?
Am I right?
I think I need process audit to answer the 1st question (conformity or nonconformity to the process requirements). And I don’t need process audit to answer the 2nd question.
What do you think about this?
Duke Okes
22nd October 2008, 04:58 PM
Audits can/should check both compliance (we're doing what we said we were going to do) and effectiveness (we're getting the results we expected).
You might want to discuss this with your registrar and your automotive customer. They are the ones you have to please.
Stijloor
22nd October 2008, 05:10 PM
Stijloor
I think I don’t need process audit to know about
"is the (manufacturing) process doing what it is supposed to do"
I think I can get this information from the complaints, scrap, rework and Cpk
A complaint may be the result of a number of ineffective processes. Just tracking complaints may not be indicative of the performance of an individual (manufacturing) process.
Rework and Scrap?? See above.
Cpk? Yes, one can link this to a particular process.
Also, see the (automotive) process approach to auditing.
Stijloor.
Peters
22nd October 2008, 06:53 PM
My friend had CB Surveillance Audit a month ago.
Observation of the auditor concerning internal manufacturing process audit(summary): "Internal process audit nonconformity - "Lack of product inspection status identification" is rather systemic nonconformity then process ineffectiveness nonconformity".
This is why I asked the question: What audit statement can be evidence of process effectiveness or ineffectiveness (during the process audit)? What nonconformity can be evidence of process ineffectiveness?
I think most of the process auditors compare reality with the requirements (and something like "good practice"). And that's all. I'm afraid they don't think about effectiveness of the process. Is it problem?
Howard Atkins
23rd October 2008, 03:16 AM
In my mind it is simple
Every process must have a objective.
If the objective is reached it is effective.
Before the audit the auditor MUST know what the objective is then with this in mind he can see the effectiveness.
The objective could be so obvious that it is not stated but make the team realize what it is.
4.1 c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
5.4.1 Quality objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)] are established at relevant functions and levels within the organization. my emphasis
Each function has their own
Raffy
23rd October 2008, 06:19 AM
Hi Peters,
Every company has a different approach on how to deal with the requirements of 8.2.2.2.
In our end we are issuing nonconformance report (NCR) for any discrepancy found during process audit. This report will highlight the problem in an area. Assignee or Action Party will fill-up the said NCR with their correction and corrective action. In our case, we monitor several metrics: 1. Response time, Goal Versus Actual. 2. Closure Date, Target Date Versus Completed Date.
Hope this helps.
Best regards,
Raffy
"8.2.2.2 The organization shall audit each manufacturing process to determine its effectiveness"
1.How can we measure process effectiveness using process audit?
2.Are the nonconformities evidence of process ineffectiveness? Are the conformity to the requirements evidence of process effectiveness?
3.What audit statement can be evidence of process effectiveness or ineffectiveness (during the process audit)?
Can you help me?
AndyN
23rd October 2008, 09:11 AM
In my mind it is simple
Every process must have a objective.
If the objective is reached it is effective.
Before the audit the auditor MUST know what the objective is then with this in mind he can see the effectiveness.
The objective could be so obvious that it is not stated but make the team realize what it is.
Each function has their own
Thank heavens for simplicity, Howard!
pinpin
26th October 2008, 06:35 AM
If the objective is not met, it could be due to incorrect objective, :D