Small Organizations Document Control and Records - Audit Confusions

C

cmfugen

#1
Hello

I would like to know that what records are or can be used as reference documents for the audit of document control and records.
Apart from the QMF documents we created other documents like approved suppliers list, supplier assessment but we gave the reference of the PRM no. and the column no. which is representing for this document, as we don’t want to add any documents to the master document manual, we just wanted to use these as supporting documents with normal reference no.s , are we on right tract

The second one is that if we are doing the audit of Management review and the Quality management representative or President were asked questions then have we to take the signatures of them as auditees or just can I move ahead with the audit of the procedure of the Management review.

The third one is that who must be the auditees I mean the person who look after that area or any body because the reason is that I wanted to do the audit of Purchase and while doing the audit of purchase procedure I would like to put few questions to the person who looks after the purchase department, in this case can I put him as the auditee.

The fourth one is that if I am auditing the corrective and preventive actions have I to take somebody else as auditee or who is responsible for corrective and preventive actions.

The reason for all these questions is our organization is very small as the President, QMR, Person to look after various wings are only one, this is the reason for confusion, can I take him as an audtee for so many areas, is that ok!

Please suggest me.
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
Re: Small Organizations- Audit Confusions

Looking at your questions and not wanting to appear rude (even though I will to some here) let me ask...Do you have any training as an auditor and have you been specifically trained to audit ISO 9001:2000 as an Internal Auditor?

Based upon your questions you are displaying a lack of general competency in the subject matter of internal audits and with basic requirements of ISO 9001:2000. To answer your questions would entail nearly giving you a complete auditor course.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#3
Re: Small Organizations- Audit Confusions

Hello

I would like to know that what records are or can be used as reference documents for the audit of document control and records.
Apart from the QMF documents we created other documents like approved suppliers list, supplier assessment but we gave the reference of the PRM no. and the column no. which is representing for this document, as we don’t want to add any documents to the master document manual, we just wanted to use these as supporting documents with normal reference no.s , are we on right tract

The second one is that if we are doing the audit of Management review and the Quality management representative or President were asked questions then have we to take the signatures of them as auditees or just can I move ahead with the audit of the procedure of the Management review.

The third one is that who must be the auditees I mean the person who look after that area or any body because the reason is that I wanted to do the audit of Purchase and while doing the audit of purchase procedure I would like to put few questions to the person who looks after the purchase department, in this case can I put him as the auditee.

The fourth one is that if I am auditing the corrective and preventive actions have I to take somebody else as auditee or who is responsible for corrective and preventive actions.

The reason for all these questions is our organization is very small as the President, QMR, Person to look after various wings are only one, this is the reason for confusion, can I take him as an audtee for so many areas, is that ok!

Please suggest me.
I agree with Randy to the point that maybe some training is needed to hone your skills as an Internal Auditor. Please don't take offense to this statement.

That said: As far as I understand your question(s) (Please correct me if I am wrong on how I interpret your questions):

You are asking is it ok that the President, The MR, Purchasing are one in the same. Yes that is ok, I don't see any issues with this.

The other question (via the post) is: With the President acting in the capacity of all of these functional areas is it ok to identify them as the Auditee. I don't see any problem with this either.

Now, my answers are based on my opinion, and some people may not agree with my opinion. That is what the Cove is all about.

If I am incorrect in my interpretation of your questions, please let me and others know.
 

Wes Bucey

Quite Involved in Discussions
#4
Re: Small Organizations- Audit Confusions

Looking at your questions and not wanting to appear rude (even though I will to some here) let me ask...Do you have any training as an auditor and have you been specifically trained to audit ISO 9001:2000 as an Internal Auditor?

Based upon your questions you are displaying a lack of general competency in the subject matter of internal audits and with basic requirements of ISO 9001:2000. To answer your questions would entail nearly giving you a complete auditor course.
Gee! I thought I had suddenly forgotten everything I knew about Quality and audits. My fear about forgetting began when I didn't know what QMF or PRM meant.
I would like to know that what records are or can be used as reference documents for the audit of document control and records.
Apart from the QMF documents we created other documents like approved suppliers list, supplier assessment but we gave the reference of the PRM no. and the column no. which is representing for this document, as we don’t want to add any documents to the master document manual, we just wanted to use these as supporting documents with normal reference no.s , are we on right tract
Was that a tract of land or a religious tract?;)
 
C

cmfugen

#5
Re: Small Organizations- Audit Confusions

ok friends, if you guys feel like that i cant do any thing,thats ok, but if you feel that i dont know any thing then can you guys give me some basic understanding to do the internal audit or to know exactly what is internal audit and who are auditors and auditees or please let me know where can i get the material about this even online, it will be a great help to me.

another thing what i seen in the forum is that if somebody asks a question no body gives the exact answer, people say that they do like this and it may be like that but guys like me who are new want to know exactly what should be done in such situations, if guys are highly experienced then they should guide the people with less knowledge but i dont know whether people will agree for this or not, i am sorry if i offend anybody.
thanks
 
Last edited by a moderator:

Eric ng

Involved In Discussions
#6
Re: Small Organizations- Audit Confusions

Is your small company ISO certified? What is job responsibility, Internal Lead Auditor?, MR? Are you doing Internal Audit or preparing for third-party certification audit?

This forum has lots of information on QMS audits that I am sure you can find answers to your concerns.

Good Luck!

Eric
 

Wes Bucey

Quite Involved in Discussions
#7
Re: Small Organizations- Audit Confusions

ok friends, if you guys feel like that i cant do any thing but if you feel that i dont know any thing then can you guys give some basic training to me to do the internal audit or to know exactly what is internal audit and who are auditors and auditees or please let me know where can i get the material about this even online, it will be a great help to me.

another thing what i seen in the forum is that if somebody asks a question no body gives the exact answer, people say that they do like this and it may be like that but guys like me who are new want to know exactly what should be done in such situations, if guys are highly experienced then they should guide the people with less knowledge but i dont know whether people will agree for this or not, i am sorry if i offend anybody.
thanks
Look! It's not that you can't do anything, but you have been apparently thrown into water over your head and told to swim for the opposite shore which you can't see when you are in the water.

In your initial post,
Hello

I would like to know that what records are or can be used as reference documents for the audit of document control and records.
Apart from the QMF documents we created other documents like approved suppliers list, supplier assessment but we gave the reference of the PRM no. and the column no. which is representing for this document, as we don’t want to add any documents to the master document manual, we just wanted to use these as supporting documents with normal reference no.s , are we on right tract

The second one is that if we are doing the audit of Management review and the Quality management representative or President were asked questions then have we to take the signatures of them as auditees or just can I move ahead with the audit of the procedure of the Management review.

The third one is that who must be the auditees I mean the person who look after that area or any body because the reason is that I wanted to do the audit of Purchase and while doing the audit of purchase procedure I would like to put few questions to the person who looks after the purchase department, in this case can I put him as the auditee.

The fourth one is that if I am auditing the corrective and preventive actions have I to take somebody else as auditee or who is responsible for corrective and preventive actions.

The reason for all these questions is our organization is very small as the President, QMR, Person to look after various wings are only one, this is the reason for confusion, can I take him as an audtee for so many areas, is that ok!

Please suggest me.
I see these problems:
  1. you are mixing up the terms auditee and auditor. The auditor is the one who looks at the work of an auditee and determines if it is being performed according to the organization's PLAN (regardless of whether the plan is called a Quality Manual, a Procedure, a Work Instruction, or a thingamabob.
  2. Anybody and everybody can be an auditee (the guy whose work is audited - remember, it is the work, not the person, which is being audited.)
  3. When an organization is small, sometimes the same person can be both an auditor and an auditee. In most cases (one man shops are a notable exception) an auditor does not audit his own work, but trades off with another person. Thus in a two man shop of Smith and Jones, Auditor Smith would audit the work of auditee Jones, then Auditor Jones would audit the work of auditee Smith.
  4. The primary purpose of the audit is to determine the following:
  • Is the work being performed to plan?
  • If yes, is it effective?
  • If not, why not?
  • If the plan is not followed and the reason is that the work seems to go better than the original plan, should the organization consider changing the plan or forcing the auditee to follow the original plan? What else can the organization do?
  • If the plan is followed and the work is effective, do either the auditor or auditee have suggestions to improve the work (called "Opportunities for Improvement")?
In the matter of documentation, your question is so bollixed, I am unable to interpret what you mean by your documents.

Basically, documentation in an organization consists of multiple levels, starting at the top with a brief basic overview of what the organization intends to do in terms of its Quality Management System (its Policy.) As the documents go down in levels, they become increasingly more specific and detailed, down to work instructions for individuals. Any and all of these levels of documents are fair targets for an audit. Essentially, the documents represent a Plan of how a process or sub-process should be performed in an efficient and routine manner. (Sometimes the documents are records of how work was performed - an auditor may examine these records to see if they jibe with the Plan) The auditor first examines the document for an understanding of what the Plan is for a process, then he goes to where the process is being performed and makes a determination whether the Plan is followed and notes (documents) what he sees. Later, he combines his report of what he saw with what he believes about whether what he saw coincides with the Plan. If not, he details why not. That audit report subsequently finds its way to Management for review. Management then makes a decision about the Plan and its process
  1. Everything is going smoothly - no action
  2. Plan is not being followed - should the operator be retrained or the plan altered?
  3. Plan is going smoothly, but there is a possibility it might be "tweaked" to be more efficient - set up someone to explore this idea and report back to management for either action or no action.
Now, despite your plea
if somebody asks a question no body gives the exact answer, people say that they do like this and it may be like that but guys like me who are new want to know exactly what should be done in such situations, if guys are highly experienced then they should guide the people with less knowledge but i dont know whether people will agree for this or not,
the plain and simple fact is the content of your posts thus far demonstrates to those highly experienced folks your understanding is not going to be improved much by some short posts (like this one) - you really need to be referred to some books and perhaps take a class in auditing (maybe from a local ASQ Section) to get a fuller and more complete understanding of the auditing process. I hope subsequent posters will supply lists of those references and suggestions for classes which you or your organization can afford.

:topic:All that said, I have been taken to task via private message from some of my colleagues for my previous abrupt response and minor joke at your expense. I publicly and humbly apologize for that. I have no excuse. Perhaps this more involved answer will make up for that lame attempt at a joke.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#8
Re: Small Organizations- Audit Confusions

ok friends, if you guys feel like that i cant do any thing,thats ok, but if you feel that i dont know any thing then can you guys give me some basic understanding to do the internal audit or to know exactly what is internal audit and who are auditors and auditees or please let me know where can i get the material about this even online, it will be a great help to me.

another thing what i seen in the forum is that if somebody asks a question no body gives the exact answer, people say that they do like this and it may be like that but guys like me who are new want to know exactly what should be done in such situations, if guys are highly experienced then they should guide the people with less knowledge but i dont know whether people will agree for this or not, i am sorry if i offend anybody.
thanks
Internal Auditing is not a simple task to learn. Here are a few things that it takes:

1. Experience in the field.
2. Knowledge of specific standards.
3. Knowledge of Business processes
4. Knowledge of human nature
5. Knowledge of Interpersonal Communication
6. Knowledge of Management Principles
7. Skills in researching
8. Skills in managing conflict

These are just a few. My suggestion is that you perform some research into outside training for Auditing. There you would find a basic understanding, basic requirements, and so forth.

Now, back to some of the other issues:

Some of your questions were confusing. The specifics weren't exactly asked. As you can see in my responses:

Coury Ferguson said:
That said: As far as I understand your question(s) (Please correct me if I am wrong on how I interpret your questions):

You are asking is it ok that the President, The MR, Purchasing are one in the same. Yes that is ok, I don't see any issues with this.

The other question (via the post) is: With the President acting in the capacity of all of these functional areas is it ok to identify them as the Auditee. I don't see any problem with this either.

Now, my answers are based on my opinion, and some people may not agree with my opinion. That is what the Cove is all about.

If I am incorrect in my interpretation of your questions, please let me and others know.
As you can see, I tried to answer your questions to the best of my interpretation.

Recommendation: The Cove is an excellent source of information, but the responses to the questions are only as good as the questions asked. Think about the questions, be specific on what you want to ask, and ask them with good clarification. Don't take things so personally, they are answers from people that have been in the field for a lot of years.
 
#9
Re: Small Organizations- Audit Confusions

ok friends, if you guys feel like that i cant do any thing,thats ok, but if you feel that i dont know any thing then can you guys give me some basic understanding to do the internal audit or to know exactly what is internal audit and who are auditors and auditees or please let me know where can i get the material about this even online, it will be a great help to me.

another thing what i seen in the forum is that if somebody asks a question no body gives the exact answer, people say that they do like this and it may be like that but guys like me who are new want to know exactly what should be done in such situations, if guys are highly experienced then they should guide the people with less knowledge but i dont know whether people will agree for this or not, i am sorry if i offend anybody.
thanks
You have been given some very reasonable advice here. The reality is that no-one can teach you the basics of auditing here, in the one dimensional world of the written word. No more than we could teach you to paint or learn any skill.

If you are in a corner, you need to know how to do an audit and you've come here for help, we can guide you to a good source of local help. Tell us which town and country you are located in and our friends from around the world will point you to some help, I'm sure.

We understand your frustration, but your response will probably offend anyone from giving more help to you. If it's a language issue (english isn't the easiest is it/), may I suggest that you get some help to be able to express your question more clearly for everyone?
 
Thread starter Similar threads Forum Replies Date
H Effectiveness of ISO 9001:2000 Implementation in small industrial organizations? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
apestate Size of QMS / Size of company - What advantages do small, simple organizations have? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Calibration of Small Scales General Measurement Device and Calibration Topics 26
J Defining staff competence - Small mechanical workshop Occupational Health & Safety Management Standards 20
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
Proud Liberal Small radius with tight tolerance on a torus General Measurement Device and Calibration Topics 4
shimonv Worthwhileness for a small startups to apply for EUA (Emergency Use Authorization) for COVID-19 US Food and Drug Administration (FDA) 17
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J SPC - Stamping parts - Small batch size Statistical Analysis Tools, Techniques and SPC 6
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 18
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Gauge Study for Small Lots Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
F AS9100D Process Matrix for a small cnc machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
E In need of a new TGA sponsor - Small software company Other Medical Device Regulations World-Wide 4
Nicole Desouza ISO / AS Certification - Small business with less than 100 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
R Inventory management for a small startup device company Other Medical Device Related Standards 1
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
E Question on GD&T added to print - Positional callout for the small holes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
C Is CE Mark needed for a small DAC audio board on top of a Rasberry PI? CE Marking (Conformité Européene) / CB Scheme 1
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1
Ed Panek Small Medical Device company - Bring production in-house ISO 13485:2016 - Medical Device Quality Management Systems 1
K Small Sample - Lower Limit Probability Statistical Analysis Tools, Techniques and SPC 0
Z Best Practices - small volume medical device tube cutting (0.020" to 0.080" OD)? Manufacturing and Related Processes 3
L REACH Compliance - Small, family-owned contract manufacturer REACH and RoHS Conversations 16
Tagin Measuring supplier quality with small quantities Statistical Analysis Tools, Techniques and SPC 10
apestate Inexpensive Gage Blocks for small aerospace startup shop General Measurement Device and Calibration Topics 1
I DOE: High variance and small effects in Minitab Using Minitab Software 1
E Small one man shop with QMS (shoptech e2) | AS9100 cert help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 46
M AS9100 - Where to start - Small company (10 employees) and I am the Quality Dept. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 45
B ISO 9001:2015 for a Small Machine Shop need Resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H AS9100D Cert question - Small machine shop - Where can I buy a certificate? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
Le Chiffre Is ISO/IEC 27001 appropriate for most small businesses? IEC 27001 - Information Security Management Systems (ISMS) 2
P Is it possible to make an educated decision using a very very small sample size? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
B Medical device manufacturer - Product certification (Small businesses) EU Medical Device Regulations 2
J Requirements for Work Transfer of Small Company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
P QMS software recommendations for a small ISO 13485 company Quality Manager and Management Related Issues 5
S Need Continuous improvement Suggestions - Small (30 of us) all-CNC machine shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
S Quality Plan at a small Medical Device Company - Is the quality plan a DMR document ISO 13485:2016 - Medical Device Quality Management Systems 6
G Setting Up a Basic Quality Lab for a small manufacturing company General Measurement Device and Calibration Topics 2
E Defined Roles in Small Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
D Number of Audit Days - AS9100D Transition for a Small Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M AS9100D excluding Design and Development - Small Job Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
R ISO 9001:2015 for Small Enterprises - Book from ISO ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Performing PQ on a Small (tabletop) Air Heat Treating Oven ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H How to Establish and Document Competence of Employees in a Small Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13

Similar threads

Top Bottom