ISO 9001 Implementation Roadblocks - Small Manufacturing Company

[PVIJOHN]

First let me apologize if this post would be better served in another forum.

I was assigned the task of Management Representative for a small Manufacturing company. We make Handicap Access ramps and Commercial Food service equipment. We employ almost 90 people.
Two months ago I began, my predecessor (My boss) had a typical procedure package and had been working with a consultant but his expertise is in building things not writing them, so here I am.
Our Management commitment is very strong, I report only to my boss and his boss both of whom I have a good relationship with.

All of our procedures and forms are complete and in final approval, looking over phase. Our Non Conforming procedures have been running for a month or so with data be collected, Our CAPAs are in the infant stages but moving. D&D is almost hashed out ( had a bit of hassles there ). Things seem to be moving smooth, almost to smooth. I think I am getting a grasp of all the moving parts of an ISO system...thanks in large part to hours of digging at this wonderful site...but I am sure that there a few common pitfalls that i should be aware of over the next month or two. We are planning on a registrar visit around christmas.

Now that I gave a bit of background, a few specific questions please. And please feel free to dump any feedback, stories, opinions ya got, I am all ears.

Is my timetable realistic?
Is understanding why we do things and how we feel we meet the standards as vital as i believe when it comes to the registrar? What i picked up is that Knowing why you do something and being able to articulate it will get you through almost all registrar problems. An example being our tape measures..we will verify they are accurate, lable them, and then inspect when using them at the employee level. We know exactly how we think we are meeting calibration standards even if an auditor disagrees will our being able to explain help better than just saying, well thats how we wanted to do it. Or is it more black and white? I guess my question boils down to how much grey is there?
What tips could you share to make the audit go as smooth as possible?
How important are the little things, good coffee? comfortable desk for him/her? All the documents at there finger tips?
Last thing. I made an Excel work book with tabs for Procedures, WI, Forms, Databases, Records with everything hyperlinked, and all the info, dates, approvals, distribution, revisions. so that all of our Quality documents can be accessed through that Excel index. Anyone work with something similiar.
Ok I'm done. Sorry about my case of blabberkeyboard.
Thank you in advance,
John

[Brunetta]

No mention of an internal audit program, how is that going?

We use an excel spreadsheet with hyperlinks, and our internal audit records are tabbed and indexed. Our auditor commented in appreciation that the organization of our records was impressive.

As for the coffee, comfy chair and whatnots, I am sure that it appreciated too, but don't go overboard. They are there to do a job, which is to look objectively at your system and make a determination of conformance to the standard.

[kuntrykidd1]

PVIJOHN,

I have gone through TS and am going through ISO14001 now. I am in the auto sector, but the "systems" are set up similar. I would suggest that you ask for an agenda from your auditor and assume that he/she will follow it to the letter. You should allow yourself a few months (6 or more) to schedule "new" audits. You need to make sure your system works complete from beginning to end and can be followed with little disruption. An auditor should be able to follow your processes with little assistance from you. Having the hyperlinks helps you find the documentation, most of it should already be organized before they get there. Follow the code book for your industry. I use my TS 16949 book and ISO 14001. Remember that your system is your system. Set it up the way it works best for your company. One of my faults were reading too much into what was required. I took simple tasks and made them difficult for myself and became frustrated. Multiple audits are a must to ensure that your system is bulletproof. If you think there might be a problem with a process, chances are there is. Double check it until you are confident. Utilize as many company people to look over your work. Fresh eyes help uncover simple flaws that can get you a minor or major. There is a lot more, but these things kept me on track. Good Luck. PS. Meals usually relax the environment and you never know, you might develop a friendship with the auditor. I have met some outstanding people by taking them to dinners. It separates work and makes it personal for both people.

[PVIJOHN]

Our Consultant was here last week to do a walkthrough and see how I had implemented what i did. She did an " audit " then. She gave a list of twenty or so Items ...mostly small. Friday we are having a management review meeting to discuss her findings. I will initiate CAs from that.
I am going to document Fridays meeting as our initial Management review. I am going to document our consultants findings as our initial audit.
The first of december we will have another management review to make sure things are still going smooth, I will document thouroughly.
I will Do an audit again at that time to identify any other things I may have missed.
From there I was thinking every three months for a management review, and audit a small part of system every month, making sure each area is audited annually.
Sound like a plan?

[Qualqueen]

In Reply to Parent Post by PVIJOHN

I will Do an audit again at that time to identify any other things I may have missed.
From there I was thinking every three months for a management review, and audit a small part of system every month, making sure each area is audited annually.
Sound like a plan?

Hi John,
One thing I haven't read here is training. Who trained you as auditor? Is is documented on your training records? Who will audit your department? The standard states that auditors shall not audit their own work. Just a couple of things to think over. Good luck

[kuntrykidd1]

In Reply to Parent Post by Qualqueen

Hi John,
One thing I haven't read here is training. Who trained you as auditor? Is is documented on your training records? Who will audit your department? The standard states that auditors shall not audit their own work. Just a couple of things to think over. Good luck

Execellent point.
Sounds like you have a pretty good grasp it. We are a small company too (70 people, 3 shifts) We do layer audits daily (a manager does it weekly) monthly manufacturing audits, and at least annually audit our QOS. We spread out our QOS on various months througout the year.

[PVIJOHN]

In Reply to Parent Post by Qualqueen

Hi John,
One thing I haven't read here is training. Who trained you as auditor? Is is documented on your training records? Who will audit your department? The standard states that auditors shall not audit their own work. Just a couple of things to think over. Good luck

Our Consultant had a Canned procedure package. In it was an auditors training program which I took. My Boss, We define it him as Quality Control Supervisor will audit my work. He also took the training offered. I am considered the Quality Control Representative. I work directly for him, and he works directly for the Plant Manager. It is a very streamlined managerial set-up and one of our big advantages I think.
Would I need any more accreditation other than the pretty certificate I got to print out.
We worked with the ISO9000 store.
Thank you very much for your replys and insight.

[Jan T]

I am a little leary on the "audit training" that was included in your "canned package". Did it discuss process auditing? Did you consultant do any type of training with you to augment the self reading? Do you have a documented audit plan? (ref 8.2.2.)

Did you take the self training and then train the person who will audit your functions? How is the competence and effectiveness of the training evaluated? Are there records?

Regards
Jan