Hello,

I am new to the forum and new to the world of Quality, so please bear with me!

I've searched the forums for this topic, but couldn't find it so I apologize if it's already been discussed.

We've recently been audited and one finding was that the document we are using as a checklist/assessment tool does not cover ISO 13485, IVDD and FDA requriements (and we are subject to all of these). While stumbling around the Internet looking for help I came across this:
ISO 13485 and FDA QSR (21 CFR 820) INTERNAL AUDIT CHECKLIST by Jack Kanholm (I'd put the link in, but I haven't posted enough yet to do this).

From the sample pages it looks great, with the right questions that will help me, as a novice, look for the right things during an audit, as well as be prepared for what external auditors will look for. However, I wanted to see if anyone had used it and their opinion, before paying for it. My company is small and low on the $$, and this will probably come out of my own pocket if I get it.

Thanks in advance for your help! :thanx:

Hello,

I am new to the forum and new to the world of Quality, so please bear with me!

I've searched the forums for this topic, but couldn't find it so I apologize if it's already been discussed.

We've recently been audited and one finding was that the document we are using as a checklist/assessment tool does not cover ISO 13485, IVDD and FDA requriements (and we are subject to all of these). While stumbling around the Internet looking for help I came across this:
ISO 13485 and FDA QSR (21 CFR 820) INTERNAL AUDIT CHECKLIST by Jack Kanholm (I'd put the link in, but I haven't posted enough yet to do this).

From the sample pages it looks great, with the right questions that will help me, as a novice, look for the right things during an audit, as well as be prepared for what external auditors will look for. However, I wanted to see if anyone had used it and their opinion, before paying for it. My company is small and low on the $$, and this will probably come out of my own pocket if I get it.

Thanks in advance for your help! :thanx:

Here is one that I found in a post using the Post Attachments List Search in the upper left corner of every forum page: ISO 13485 Practical Audit Checklist (http://elsmar.com/Forums/showthread.php?t=7425)

In the forum, files are 'Post Attachments'. At the top of every forum page on the left side of the page there is a Post Attachments Listing (http://elsmar.com/Forums/fileslist.php) button. Use it to get to the files listing which has a Search box in it.

http://elsmar.com/jpg/File Search 090220_700.jpg (http://elsmar.com/Forums/fileslist.php)

This may help you.

Thanks, I read this thread and looked at the attached documents, but they looked either too process-oriented or too broad (I think right now our company and those who will be auditing, including myself, need a little more direction). That's why the one I'm asking about looked so appealing.
One of our auditors shared the checklist they use with me, but it was 80 pages long! That seemed like a bit much.

Thanks, I read this thread and looked at the attached documents, but they looked either too process-oriented or too broad (I think right now our company and those who will be auditing, including myself, need a little more direction). That's why the one I'm asking about looked so appealing.
One of our auditors shared the checklist they use with me, but it was 80 pages long! That seemed like a bit much.

Process oriented is the way everything is going. Well, if you want to spend the money, in my opinion than go ahead.

I can't remember which one I used, but I did find a good template from our Post Attachments List when I decided to revise our checklist. We, too, must comply with both ISO 13485 and 21 CFR 820, and the checklist I came up with (with the help of the one I found in the link at the upper left of this page) is satisfactory for our needs and our ISO auditors didn't have a problem with it, either. Just a little tweaking and changing of a few things and it works well for us.

Why spend the extra $$ if you don't need to? But, it is your decision....

Hello,

I am new to the forum and new to the world of Quality, so please bear with me!

I've searched the forums for this topic, but couldn't find it so I apologize if it's already been discussed.

We've recently been audited and one finding was that the document we are using as a checklist/assessment tool does not cover ISO 13485, IVDD and FDA requriements (and we are subject to all of these). While stumbling around the Internet looking for help I came across this:
ISO 13485 and FDA QSR (21 CFR 820) INTERNAL AUDIT CHECKLIST by Jack Kanholm (I'd put the link in, but I haven't posted enough yet to do this).


Thanks in advance for your help! :thanx:

this is a check list that I found on this forum awhile ago (does not cover 820 requirements). It might still be here.

Thanks to all of you for your input! And thanks for the checklist. It's still here and perhaps I can tweak it so that it covers 820 too. I appreciate the help!

this is a check list that I found on this forum awhile ago (does not cover 820 requirements). It might still be here.

I posted that checklist a couple of years ago. I've got a version that has added the Canadian CMDCAS requirements as well, but I've never done a version with the 21 CFR 820 requirements. Maybe someday...

You can probably add the 820 requirements to the checklist similar to the CMDCAS in this one. If you do update it, please post it here. :)

Thank you! If I do update the checklist, I will be sure to post it.

It's taken me a couple of weeks, but I've finished at least a first try at updating howste's checklist with 21CFR 820 requirements. It's not perfect, but I thought I would post it anyway. I've removed a few items about sterilization, as they don't apply to my company. I was hoping to do more color coding, but I ran out of steam. :)

If anyone finds anything truly amiss, I would love to know.

As I'm new to the site, if there's any place I should post this, please let me know.

Thanks!

It looks like you've done a great job in updating it!

I have just one suggestion, since you asked for feedback. You may want to include more open-ended questions on the checklist. If the checklist has closed-ended questions written, the auditor(s) using the checklist tend to ask more yes/no questions. Most auditees have been taught to give a short answer when asked a question by an auditor. The auditee may just say "yes" and stop talking.

For example, instead of asking "is product protected from damage?" (auditee says "yes") you might want to ask "how is product protected from damage?" instead. There is generally no short answer to the second question.

Thank you howste, that is excellent feedback! I will go through and incorporate more open-ended questions. Fortunately I am the only one that will be using the checklist at first, but it's definitely something I will put on my "To Do" list. When I get it updated, I'll post it again.

Thanks again! You've been so helpful to me in my short time on the forum. I appreciate it!

Good job folks; I haven't seen a checklist this through. Is it OK if I use it when doing internal auditing for my clients?

As with many other answers (in other auditing threads) here relating to the use of checklists, internal audits shouldn't be done to this style of list. Turning the various requirements of any standard into a bunch of questions is not effective as the basis for an audit strategy, especially given the level of understanding of most auditors, fresh out of a training course!:nope:

Internal auditors and auditing should be focused on the business processes. Given a standards based checklist, most auditors will form their thoughts and ask questions based on what's written down! What kind of answers are people going to give, when they hear the 'jargon' of the standards?:mg:

Worse, the use of such canned checklists abrogates the needs for the internal auditor to adequately plan and prepare for the audit. There is no 'buy in' to the task. Therefore it becomes a parody of an audit. The result may be satisfactory to get by a CB auditor, but it's not going to demonstrate and effective audit program!:notme:

I would agree that checklists are simply a guide to questions that one might ask. It helps the auditor stay on track and ask process related questions. I've been involved in many audits and the majority of the auditiors use some form of checklist to guide the audits. I was merely trying to give credit to what I thought was a job well done by the folks that put a lot of hard work into their checklist.

I would agree that checklists are simply a guide to questions that one might ask. It helps the auditor stay on track and ask process related questions. I've been involved in many audits and the majority of the auditiors use some form of checklist to guide the audits. I was merely trying to give credit to what I thought was a job well done by the folks that put a lot of hard work into their checklist.

Oh, yes Larry, hard work indeed. But is it effective? We see much hard work here, by Cove contributors - for example, Quality Manuals by the boatload, but are they effective?

I took a look at the checklist in post #10. I'd be interested in your views (since you're new to the Cove) on how such a checklist fosters a 'process approach' to auditing?

I would agree that checklists are simply a guide to questions that one might ask. It helps the auditor stay on track and ask process related questions. I've been involved in many audits and the majority of the auditiors use some form of checklist to guide the audits. I was merely trying to give credit to what I thought was a job well done by the folks that put a lot of hard work into their checklist.

The use of a checklist during audits is much maligned here in the Cove, however, I too believe that a well developed checklist can be a useful audit tool. Checklist questions do not have to be written using "standard jargon" nor do they have to rephrase the standard's "shalls" into questions. Checklist questions can, and should, be process oriented.

Perhaps the quality profession should take note of the successful use of checklists in reducing surgical errors.

If a checklist is used for an audit, I prefer to customize it for each process and audit. The checklist above can be used as a pool of questions/requirements to pull from, which I would do in the audit planning phase. Other questions would be added as appropriate from company procedures and other documents.

You definitely shouldn't audit by following the sequence of the requirements. You should, as Andy noted, audit per the process itself. Arranging the questions/requirements into a more logical sequence which flows with the process itself is a much better approach.

Thanks, Howste, for that insight!

Unfortunately, too many auditors are shoved off to do an audit, armed with such a checklist, without any form of preparation or customization! Why do I know this to be true? I have been asked to do 'remedial' training of auditors who have been given such assignments!

For years, training has focused on how to do audits, so maybe it's time for RABQSA etc to step up and require training on how to manage audit programs, of which the development and use of checklists should be a (small) part......

Good job folks; I haven't seen a checklist this through. Is it OK if I use it when doing internal auditing for my clients?

Hi Larry CP, as far as I'm concerned you can use it.

This is a very interesting discussion! As I am new to Quality in general, and new to auditing, I was looking for a checklist that covered all the standards my company follows and was extremely thorough. The goal was to use it as a guide, not necessarily follow the checklist to the letter. It certainly makes sense that an audit should be tailored to the task at hand (i.e. system audit vs process vs product). However, how do you know, without a checklist, that you are asking the right questions? I would be interested to hear any tips you may have for a new auditor. Thank you!

This is a very interesting discussion! As I am new to Quality in general, and new to auditing, I was looking for a checklist that covered all the standards my company follows and was extremely thorough. The goal was to use it as a guide, not necessarily follow the checklist to the letter. It certainly makes sense that an audit should be tailored to the task at hand (i.e. system audit vs process vs product). However, how do you know, without a checklist, that you are asking the right questions? I would be interested to hear any tips you may have for a new auditor. Thank you!

It requires a mindset change from what's taught in courses. Let's start by defining what the scope and criteria of the audit is....... Then, it shouldn't be too difficult to formulate a set of questions, from studying the criteria.

Essentially, what you want to do is have the people who own and operate the process describe to you that process and its controls. Take any process, one even away from work - like cooking breakfast - and just 'brain storm a bunch of things you'd need to know about the process. Don't get carried away (like wondering if you have to audit the farm where the eggs came from, because that's not within 'scope'!) but you an include objectives, results, process controls, competencies of people making it, etc etc.

Seriously, it's not so difficult to formulate questions - most of us have been doing this since we were 3 or 4 years old......

Hmm, that's a great way of thinking about it. I will use that idea as I move towards preparing for my next audit. Thank you!

Hmm, that's a great way of thinking about it. I will use that idea as I move towards preparing for my next audit. Thank you!

You are very welcome!

Using this example, would you share with us your understanding of the audit of 'breakfast' you'd undertake? It would help me (and our other devotees) to see what questions you'd formulate to ask whomever would be preparing breakfast. If I may be permitted to start....

What are the objectives of the breakfast making process?
How will you measure the results (yours and the 'customers'?)

You are very welcome!

Using this example, would you share with us your understanding of the audit of 'breakfast' you'd undertake? It would help me (and our other devotees) to see what questions you'd formulate to ask whomever would be preparing breakfast. If I may be permitted to start....

What are the objectives of the breakfast making process?
How will you measure the results (yours and the 'customers'?)
Hmm, how's this for a start:

How do you train the people making the breakfast? How do you measure that they know how to make it correctly?
Do you document the breakfast process and if so, how do you do that?
How do you decide which breakfast products to make? What are the inputs?
How do you decide what equipment you use and/or need? How do you ensure that equipment is working properly?
How do you maintain a clean environment for your breakfast to be made in?

Hmm, how's this for a start:

How do you train the people making the breakfast? How do you measure that they know how to make it correctly?
Do you document the breakfast process and if so, how do you do that?
How do you decide which breakfast products to make? What are the inputs?
How do you decide what equipment you use and/or need? How do you ensure that equipment is working properly?
How do you maintain a clean environment for your breakfast to be made in?

Yup, you've got a good idea - you could even start with the objectives and customer requirements for breakfast..........even before you get to having to consider the equipment, for example, that necessary for oatmeal for 1 is going to be significantly different than for eggs, meat, pancakes, coffee, juice etc. for a whole family....that way, when it comes to asking about outputs and measurements it's easier to determine if the 'goals' were met......

I bought Jack's Internal Audit Checklist. For me, it's definately worth the money. How many hours are you going to spend creating your own that meets both ISO and CFR 820? His checklist is very thorough. I combine his checklist with my own to make sure I cover all the bases.

I have been searching for some sort of ISO 13485 list all week. thank you and the person who wrote this!!!!!!! I still can't seem to find the actual regulation any where online. Do you have to pay to get it???
I had problems finding CFR 21 part 11 info until I found it with System Suitability information.
It seems you must be in some special secret club just to find these REQUIRED REGULATIONS. Anyone know the secret handshake?

I have been searching for some sort of ISO 13485 list all week. thank you and the person who wrote this!!!!!!! I still can't seem to find the actual regulation any where online. Do you have to pay to get it???
I had problems finding CFR 21 part 11 info until I found it with System Suitability information.
It seems you must be in some special secret club just to find these REQUIRED REGULATIONS. Anyone know the secret handshake?

Are you looking for ISO 13485? If so, I think you have to pay (that was the only way I could figure out how to obtain it). The FDA regs can be found online for free at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm.

Megan

I have been searching for some sort of ISO 13485 list all week. thank you and the person who wrote this!!!!!!! I still can't seem to find the actual regulation any where online. Do you have to pay to get it???
I had problems finding CFR 21 part 11 info until I found it with System Suitability information.
It seems you must be in some special secret club just to find these REQUIRED REGULATIONS. Anyone know the secret handshake?

What regulation are you looking for? If you mean the FDA medical device regulations, you can find 21 CFR 820 here (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1). If you're talking about ISO 13485, you won't find it online because it's not a regulation. It's a copyrighted ISO standard, and it must be purchased.

Wow - same info posted at the same time... :agree1:

Yup, you've got a good idea - you could even start with the objectives and customer requirements for breakfast..........even before you get to having to consider the equipment, for example, that necessary for oatmeal for 1 is going to be significantly different than for eggs, meat, pancakes, coffee, juice etc. for a whole family....that way, when it comes to asking about outputs and measurements it's easier to determine if the 'goals' were met......

I'm so sorry Andy, I just realized that I never thanked you for your help with better understanding how to go about an internal audit! Thank you! I am conducting my first audit this month - your help will be an asset!

Megan

I'm so sorry Andy, I just realized that I never thanked you for your help with better understanding how to go about an internal audit! Thank you! I am conducting my first audit this month - your help will be an asset!

Megan

Delighted to help, Megan! Let us know if this approach worked for you - how well! And if it does, I'll use it in my internal auditing book and you can have a free copy!