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Does this look like a Process Audit?

jeepdog

Starting to get Involved
#1
I just read the threads and I would like to add a question if I may. I too have been going nuts w/ the idea of process auditing. If I perform what I presume is a process audit for a detail part coming in the door and making its way to stock (i.e. product realization) we go thru - shipping receivers – PO clauses – Op. sheets - inspection- calibration -secondary machining- tooling- signed operations – evidence of inspection- shipping- packaging - purchase orders & approvals – approved vendors –special processes – flow down requirements- risk- Stock.

By the time I’m done preparing for this audit, I have 109 questions on a checklist which I’m told I’m not supposed to need or use and I’m told I’m auditing elements not the process. The questions I have developed come from our procedures and instructions. I ask things like “Is there evidence Critical characteristics are identified on ICL’s”, “Is there evidence Op. sheets are approved and have a revision” “Is there evidence of an approved list of vendors” and so on.
Essentially I turn every action stated in every procedure and instruction in the chain into a question.

I feel I am doing a process audit as I get from one end to the other and that a checklist is appropriate, but in the end I have a lengthy audit. Is an audit of 109 questions unusual? My auditors balk at what seems like a lot of questions but how do I show we do what we say without asking the questions? Am I too deep in the weeds with my questions? And I am newly RABQSA auditing certified (though I never got to get to this question for my first party audits). Sorry about the amount of info here!
 

Jim Wynne

Staff member
Admin
#2
I just read the threads and I would like to add a question if I may. I too have been going nuts w/ the idea of process auditing. If I perform what I presume is a process audit for a detail part coming in the door and making its way to stock (i.e. product realization) we go thru - shipping receivers ? PO clauses ? Op. sheets - inspection- calibration -secondary machining- tooling- signed operations ? evidence of inspection- shipping- packaging - purchase orders & approvals ? approved vendors ?special processes ? flow down requirements- risk- Stock.

By the time I?m done preparing for this audit, I have 109 questions on a checklist which I?m told I?m not supposed to need or use and I?m told I?m auditing elements not the process. The questions I have developed come from our procedures and instructions. I ask things like ?Is there evidence Critical characteristics are identified on ICL?s?, ?Is there evidence Op. sheets are approved and have a revision? ?Is there evidence of an approved list of vendors? and so on.
Essentially I turn every action stated in every procedure and instruction in the chain into a question.

I feel I am doing a process audit as I get from one end to the other and that a checklist is appropriate, but in the end I have a lengthy audit. Is an audit of 109 questions unusual? My auditors balk at what seems like a lot of questions but how do I show we do what we say without asking the questions? Am I too deep in the weeds with my questions? And I am newly RABQSA auditing certified (though I never got to get to this question for my first party audits). Sorry about the amount of info here!
Has your company identified its QMS processes? Those are the processes you should be auditing. What is the process you're referring to? While there might be trails that lead into other processes, 109 questions is definitely excessive.
 
#3
I just read the threads and I would like to add a question if I may. I too have been going nuts w/ the idea of process auditing. If I perform what I presume is a process audit for a detail part coming in the door and making its way to stock (i.e. product realization) we go thru - shipping receivers – PO clauses – Op. sheets - inspection- calibration -secondary machining- tooling- signed operations – evidence of inspection- shipping- packaging - purchase orders & approvals – approved vendors –special processes – flow down requirements- risk- Stock.

By the time I’m done preparing for this audit, I have 109 questions on a checklist which I’m told I’m not supposed to need or use and I’m told I’m auditing elements not the process. The questions I have developed come from our procedures and instructions. I ask things like “Is there evidence Critical characteristics are identified on ICL’s”, “Is there evidence Op. sheets are approved and have a revision” “Is there evidence of an approved list of vendors” and so on.
Essentially I turn every action stated in every procedure and instruction in the chain into a question.

I feel I am doing a process audit as I get from one end to the other and that a checklist is appropriate, but in the end I have a lengthy audit. Is an audit of 109 questions unusual? My auditors balk at what seems like a lot of questions but how do I show we do what we say without asking the questions? Am I too deep in the weeds with my questions? And I am newly RABQSA auditing certified (though I never got to get to this question for my first party audits). Sorry about the amount of info here!
If you're really going from one end to the other using this amount of scope, I'd say that what you're doing is a system audit, not a process audit. Individual processes make up a system. A registrar would be the group primarily interested in doing system audits.

Unless you've actually identified this entire flow as one process, I'd break it up into discrete processes and audit them that way. E.g. Purchasing, Production, NCM control, Inspection (incoming, in process, final), Order handling, Demand management etc. You could bundle control of docs , records, calibration, audits, CAPA as a QA process, supporting the PR activities.
 

John Broomfield

Staff member
Super Moderator
#4
I just read the threads and I would like to add a question if I may. I too have been going nuts w/ the idea of process auditing. If I perform what I presume is a process audit for a detail part coming in the door and making its way to stock (i.e. product realization) we go thru - shipping receivers ? PO clauses ? Op. sheets - inspection- calibration -secondary machining- tooling- signed operations ? evidence of inspection- shipping- packaging - purchase orders & approvals ? approved vendors ?special processes ? flow down requirements- risk- Stock.

By the time I?m done preparing for this audit, I have 109 questions on a checklist which I?m told I?m not supposed to need or use and I?m told I?m auditing elements not the process. The questions I have developed come from our procedures and instructions. I ask things like ?Is there evidence Critical characteristics are identified on ICL?s?, ?Is there evidence Op. sheets are approved and have a revision? ?Is there evidence of an approved list of vendors? and so on.
Essentially I turn every action stated in every procedure and instruction in the chain into a question.

I feel I am doing a process audit as I get from one end to the other and that a checklist is appropriate, but in the end I have a lengthy audit. Is an audit of 109 questions unusual? My auditors balk at what seems like a lot of questions but how do I show we do what we say without asking the questions? Am I too deep in the weeds with my questions? And I am newly RABQSA auditing certified (though I never got to get to this question for my first party audits). Sorry about the amount of info here!
jeepdog,

What is the name of this process?

What is your audit objective?

Auditors usually sample to verify effectiveness. Six questions are usually enough to initiate discussion and elicit evidence of effectiveness at critical points along the process necessary to fulfill the process audit objective.

When auditing you should have no need to repeat the comprehensive process monitoring already completed many times over by your colleagues.

John
 

jeepdog

Starting to get Involved
#5
Thank you all for responding- I?m buried in work which I guess is good but delays my response time. This was typed before I read your additional responses 1:55 NY time
To be concise: We have identified 4 core processes; Customer Order Process- Design Process ? Product Realization ? Management Systems (3rd party auditors balked at more because then they have to create more PEARS). Regardless, I am trying to break down our processes for auditing purposes to 7 basic areas.
1) Management Review ( to include 5.1 through 5.6.3 and 8.2.1, 8.2.2)
2) Resources and training ( to include 6.1 through 6.4)
3) Contracts ( to include 7.11 through 7.1.3 and 7.2.1 through 7.2.3)
4) Design (to include 7.3.1 through 7.3.7)
4) Purchasing (to include 7.4.1 through 7.5.1 and 7.1.4)
5) Product Realization (to include 7.5.2 through 7.5.5)
6) Calibration and Inspection (to include 8.2.3, 8.2.4 and 7.6)
7) Non-conforming product (to include 8.3 through 8.5.3)
My previous inquiry concerned #5 above ?Product Realization? I am trying to audit the process as stated in my previous question. I?m auditing the process of taking a detail part in from start to finish. Each function along the way has over 20 auditable sub routines I can ask. These functions include; OP sheets, calibration, purchase orders, shipping, stock room, etc.
So am I way down too deep in the weeds? Can I ask general questions and still satisfactorily cover the audit?
My audit objective has always been to see that we do what we say we do and meet contractually our customer?s requirements. Output Objectives and such, not so much.
 

John Broomfield

Staff member
Super Moderator
#6
Thank you all for responding- I?m buried in work which I guess is good but delays my response time. This was typed before I read your additional responses 1:55 NY time
To be concise: We have identified 4 core processes; Customer Order Process- Design Process ? Product Realization ? Management Systems (3rd party auditors balked at more because then they have to create more PEARS). Regardless, I am trying to break down our processes for auditing purposes to 7 basic areas.
1) Management Review ( to include 5.1 through 5.6.3 and 8.2.1, 8.2.2)
2) Resources and training ( to include 6.1 through 6.4)
3) Contracts ( to include 7.11 through 7.1.3 and 7.2.1 through 7.2.3)
4) Design (to include 7.3.1 through 7.3.7)
4) Purchasing (to include 7.4.1 through 7.5.1 and 7.1.4)
5) Product Realization (to include 7.5.2 through 7.5.5)
6) Calibration and Inspection (to include 8.2.3, 8.2.4 and 7.6)
7) Non-conforming product (to include 8.3 through 8.5.3)
My previous inquiry concerned #5 above ?Product Realization? I am trying to audit the process as stated in my previous question. I?m auditing the process of taking a detail part in from start to finish. Each function along the way has over 20 auditable sub routines I can ask. These functions include; OP sheets, calibration, purchase orders, shipping, stock room, etc.
So am I way down too deep in the weeds? Can I ask general questions and still satisfactorily cover the audit?
My audit objective has always been to see that we do what we say we do and meet contractually our customer?s requirements. Output Objectives and such, not so much.
jeepdog,

Of your four processes only three are processes:

  1. Securing customer orders (selling?)
  2. Designing (products and their processes?)
  3. Realizing (and delivering) products
Management Systems is not a process.

Developing your management system for the convenience of your third party auditors is appalling to me.

Your process owners could usefully complete their own PEARs (of the key processes within your core process) in any case.

Best wishes,

John
 
#7
JD - any process can be audited from a basic premise of:

What's the objective (s) for the process ? These may be managements or customers. e.g. Got to make 100 of X and 200 of Y with zero scrap or rework (100% FTT)
What's the plan for process and how is it controlled? For example a machining process uses travellers and they define the various steps to go through including any inspections.
Are any documents needed the right ones? Work instructions, check sheets, move tickets etc.
Are there any inspections made and what equipment is used? If it is necessary to calibrate them, has it been done?
Do they make rejects? If so are they tagged etc.
WHat records do they keep of the process? What do the results show in terms of the objectives in Q1?
IF they are making rejects, how are they meeting their plans? Do management know? Are there shortages or problems being caused by other processes (suppliers? design specs? etc.
Of course, you can throw in preservation/tagging of the parts/assemblies too for good measure!

This might be enough to get going on a small-scale audit to give auditors some practice etc. Keep your eyes open for issues, so that the next process audited can be linked to this one for problem reolution - like machine pm for example, which may be causing downtime!
 
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