I'm a newbie here. I'm currently preparing checksheet for the soon coming internal audit. The problems I'm facing is, I'm confused how I suppose to set the questionaire. Previously, my company run internal audit solely refering to Quality System Procedure and without a checksheet. Therefore the audit result is very subjective. When I take over, I found that the Procedure is not really been updated and many details left out. Should I develope the checklist base on every department or base on the chapter in the QSP manual? By the way,process owner for each process are cross related. Should I be more specific when develope the questionaire to every department? Thanks.

Refer to the respective sections on ISO 9001, 14001, 13485 or 16949 in these forum and you will get great audit checklists :D

No need to reinvent the wheel :bonk:

In addition to above you may consider the following:

1. Develop check list for each process / department seperately.
2. Go through the documented procedure/s (including mandatory procedures) for that process / department or take a reference from the manual.
3. Make points of what you would want to check. Some clauses may already have been specified by MR.
4. You may refer to samples of one process and audit related activities in the particular process you are auditing.
5. It is good to be specific to a particular department.

However, one should keep in mind that the checklist is not a limiting factor. It is a guiding tool which the auditors develop for themselves to audit effectively. If some other point catches your attention during the audit, please do ask questions / examine on that point as well and include it in your checklist then.

Welcome to the Cove, Marcus :bigwave: Should I develope the checklist base on every department or base on the chapter in the QSP manual? By the way,process owner for each process are cross related. My suggestion would be to audit processes rather than departments.

Interaction between different departments is a very common problem area. Assume a process stretching over several departments (which is often the case): If you audit only the part of this process found within a certain department, it is very likely that you will miss things.

/Claes

Dear Claes,
I was having the same thought earlier. But most of the processes are cross functioning and involving various process owner from different department. How I suppose to audit a process at 1 shot? And the a single department itself has handle more than 1 process. It will be messy if, without a good planning. Thanks.

Dear Claes,
I was having the same thought earlier. But most of the processes are cross functioning and involving various process owner from different department. How I suppose to audit a process at 1 shot? And the a single department itself has handle more than 1 process. It will be messy if, without a good planning. Thanks.

I couldn't agree with you more, it's not necessary to develop a checklist.

But most of the processes are cross functioning and involving various process owner from different department. How I suppose to audit a process at 1 shot?I see what you mean. Personally, I follow the process without giving a dickens about what departments it happens to pass through. And sure enough: Problems do have a tendency to present themselves where the process moves from one department to another...

/Claes

Previously, my company run internal audit solely refering to Quality System Procedure and without a checksheet. Therefore the audit result is very subjective. When I take over, I found that the Procedure is not really been updated and many details left out.

Well Marcus why do you want to develop a checklist? If you could do an audit without one in the previous company, you can also do it here. Does your internal audit procedure specifically ask for use of checklist? If not, forget it.

You say that the procedures are not really updated. So they themselves are likely to be source of a lot of audit findings. Base your audit on the standard. Pick up processes as Claes has suggested and do a cross departmental audit. See to it that all applicable clauses in the standard are covered by your plan.

You dont need to use a checklist unless ofcourse your procedure tells you that you must. In that case, you can consider updating your procedure. You need to update most of therm anyway!

Speaking for myself, I do use checklists. Previously, my company run internal audit solely refering to Quality System Procedure and without a checksheet. Therefore the audit result is very subjective.

I suggest a look at some previous discussions on the same subject:
Internal Audit Checklists - Using the standard itself replace any checklist (http://elsmar.com/Forums/showthread.php?t=2320)
Conducting an ISO 9001, Clause 5.xx audit (http://elsmar.com/Forums/showthread.php?t=15071)

A search will dig up many more similar threads, and as far as auditing goes I also recommend this one: The 10 Essential ISO 9001:2000 Audit Questions (http://elsmar.com/Forums/showthread.php?p=73173#post73173)

/Claes

I suggest a look at some previous discussions on the same subject:

A search will dig up many more similar threads, and as far as auditing goes I also recommend this one: /Claes

Thanks Claes. You have nicely summarised all related threads. :applause:

A different point of view:

Develop a checklist IF your internal auditors have little experience, so a structured checklist will definitely help.

Do not use any checklist IF auditors have vast experience asking the right question (more often than not they stray).

Both methods (structured vs. open) offer advantages and disadvantages, so you may go in between by combining the benefits of the 2.

I recommend an open-ended process oriented checklist with 3 sections:

1. The Report Card section:
process performance metrics, criteria for effectiveness, objectives, complaints, inputs and outputs. Review Turtles if they exist.

2. Audit the actual process itself. Use the flowcharts, work instructions, control palns FMEAs, drawings. Take a good look at all the ins and outs of the process.

3. Audit the linkages to related processes, especially supporting processes, gages, doc control, training, records, etc.

If you do this, and write a good summary for the process owner, you should get good results.

My key suggestion remains. If your audit procedure says 'use a checklist', then you must. You have got many good suggestions on how you could do it so far.

If your audit procedure is silent on checklists, you are the best judge on whether you need to use one at all. And if so, in what format. Exercise your judgement and maintain your freedom of using it when you consider it helpful, or else do without one if it becomes a problem.

I don't like "canned" checklists, but they can be useful to help launch a new auditor to learn to ask certain types of questions. An auditor should soon learn to write his or her own questions, based on the nature of the process and a study of procedures and "desk audit" (looking up computerized records) learnings.

The main reasons I use a checklist are to ensure I remember to ask certain questions, and to link the questions with Standard requirements/process document elements.

I write checklists based on previous audit results, what the specs/instructions call out, and control aspects. Some control aspects, like cleanliness and training, are included in almost all my checklists. Others vary but the structure is the same.

These lists get populated with sample data, notes, observations and so on, and are identified as nonconformancies as needed so followup audits are easier to plan.

Some processes end up without checklists. I might use a combination of flow charts and turtle diagrams for support processes, especially if they don't have clear or linearly written procedures to compare activities against.

Please refer following document for Audit Check list. This as well as other lot of useful information regarding Audit is available on the APG website as mentioned.