I hope I don’t overextend my welcome here with all my inquiries, but the closer the date of the real audit gets, the more I keep identifying potential deficiencies in the work I have done and am doing.

Here’s another one that more than likely will not have a single right answer, and again I wonder how some of you approach the issue.

I am responsible for preparing the company for ISO 9001:2000 certification, and I report directly to the president. There also is a Quality Control Manager, who reports to the president as well. Even though I work closely with QC, I do not report or have anything to do with them organizational-wise. My two functions here as a full-time independent contractor are Management Representative, as for ISO 9001:2000, and manufacturing and process engineer.

Even though I wrote all the procedures after interviewing the managers and personnel involved in each area, it was a clear-cut decision when it came to assign a department or function to be responsible for each procedure. The same holds true for most forms; someone (the author) created them and may change them as needed, but a department, which may not be related to the author, uses them (turns them into ‘records’) and keeps these records.

My concern is that there are some procedures and forms that I have authored on my own; e.g., Control of Documents, Internal Audits, audit Checklists, and several others, over which I am laboring in assigning departmental responsibility. Since these procedures, forms, and records (activities in general) did not exist before, there is no department responsible for them. Also, since I am the individual responsible for their implementation and maintenance, and I do not belong to a department, they are in limbo.

In our case, who would you say and what department or function should be responsible for Control or Documents, Control of Records, Internal Audits, Audit Checklists, Management Responsibility (audit result reviews and so on), Master Documents list, Master Records list, and similar?

Thanks!

Alex

who would you say and what department or function should be responsible for Control or Documents, Control of Records, Internal Audits, Audit Checklists, Management Responsibility (audit result reviews and so on), Master Documents list, Master Records list, and similar?

In our organization, the Mgmt Rep is responsible for the activities/funtions you describe. It just so happens that the Mgmt Rep is also the head of the QA Department. When auditing, I assume the Mgmt Rep to be the point of contact for the activites/functions described. I am sure there are many exceptions though.

The management rep is repsonsible at our facility as well.

As for approval of the procedures, either the President or the Vice President is responsible for final approval. We also require approval by the author and approver and review/agreement by all involved parties.

My concern is that there are some procedures and forms that I have authored on my own; e.g., Control of Documents, Internal Audits, audit Checklists, and several others, over which I am laboring in assigning departmental responsibility. Since these procedures, forms, and records (activities in general) did not exist before, there is no department responsible for them. Also, since I am the individual responsible for their implementation and maintenance, and I do not belong to a department, they are in limbo.

In our case, who would you say and what department or function should be responsible for Control or Documents, Control of Records, Internal Audits, Audit Checklists, Management Responsibility (audit result reviews and so on), Master Documents list, Master Records list, and similar?

Similar to Badgerman and mshell, as head of QA (and the sole member of it, too), I'm responsible for authoring documents in the areas that you've listed. But you seem more concerned about associated departments with them, as opposed to questioning who penned them.

Might I suggest the following....the department you belong to is Admininistration. After all, you are the Management Representative (i.e., representing Management aka Administration). There is no need to create a "department name" for yourself...use what is currently in place.

Yes! - Administration it shall be, and it is correct! (Thanks Roxane.)

As a matter of fact, 'Administration' is what I had originally written months ago, but since it wasn't a 'real' department, I wondered its acceptability. As suggested, I didn't want to create a new department just for this purpose.

Thanks -

Alex

As a matter of fact, 'Administration' is what I had originally written months ago, but since it wasn't a 'real' department, I wondered its acceptability. As suggested, I didn't want to create a new department just for this purpose.

Truth be told, there is no Administration Department here, either. However, we have the Administration Key Indicator meeting once a month. Attendance at this meeting involves a group of people I affectionately refer to as "The Island of Reject Toys." Small departments with no true home and having a meeting by themselves would be lacking in information. So this is a wonderful way for people in accounting, purchasing, stores, raw materials and information systems to understand other aspects of the business.

Truth be told, there is no Administration Department here, either. However, we have the Administration Key Indicator meeting once a month. Attendance at this meeting involves a group of people I affectionately refer to as "The Island of Reject Toys." Small departments with no true home and having a meeting by themselves would be lacking in information. So this is a wonderful way for people in accounting, purchasing, stores, raw materials and information systems to understand other aspects of the business.

"Island of Reject Toys" Top funny. I refer to mind as the "Land of the Misfit Toys", taken from the Christmas special I watched when I was young. You remember the one. There was something wrong with every toy, but as a group they found a way to work together". Glad to see I am not the only one in that enviroment!

"Island of Reject Toys" Top funny. I refer to mind as the "Land of the Misfit Toys", taken from the Christmas special I watched when I was young. You remember the one. There was something wrong with every toy, but as a group they found a way to work together". Glad to see I am not the only one in that enviroment!

That's what I was referring to...unfortunately, I forgot it was Misfit and Reject appears to have stuck. Especially since in a few cases they used to attend the meetings with other departments until they were politely "booted" out (prior to my arrival).

Here's to all the Misfits and their continuing success! :drunk:

Suggestion: think process approach, rather than department. Who owns the process. who uses the process. who is accountable in the process?

Surely, certain processes are closely tied to departments, but if your organization is to truly embrace and meaningfully implement 9k2k, THINK PROCESS and elect process owners.

Departmental thinking promotes little feuds. Process thinking is the way to go.

One way to determine the process owner is to determine to whom you will assign the final audit report. Which member of the organization should be responsible for ensuring that effective action is taken to address any nonconformances?

We are a small organization so we are limited on "process owners". We have the President, Vice President & Customer Support/Product Development Manager. The last organization that I worked for was a lot bigger and we assigned every process to a member of the management team. Every management member was responsible for at least one of the QMS processes.

One way to determine the process owner is to determine to whom you will assign the final audit report. Which member of the organization should be responsible for ensuring that effective action is taken to address any nonconformances?

We are a small organization so we are limited on "process owners". We have the President, Vice President & Customer Support/Product Development Manager. The last organization that I worked for was a lot bigger and we assigned every process to a member of the management team. Every management member was responsible for at least one of the QMS processes.It may seem "wishy washy" to many, but in small organizations or those with a high turnover of personnel [for any reason], it is always best to assign "ownership" to a department head by title, rather than name, granting that department head the authority to delegate "temporary ownership" to anyone. This may be easier to accept if we think of the ORGANIZATION as a whole being the "owner" and its CEO as the delegated temporary owner of EVERY process, who in turn delegates temporary ownership to others by either name or position. Authorship does NOT, in my opinion, automatically confer ownership of a process any more than Quickbooks owns the accounting process of myriad organizations.