Ridiculously Underqualified and Need Some Guidance
- Thread starter Gwerner
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Randy
Super Moderator
Start by studying your stuff.
There are some ISO for "Dummies" type books out there. Search here for recommendations. Start with that to get the lay of the land. Then read a bunch of posts here to get some real life experiences.
Johnnymo62
Haste Makes Waste
Like Randy said, you should be reading the stuff already in place at your company.
I would review the last 3 years of audit findings from your registrar. This will let you know if there are major problems lurking. Any findings will relate to the requirements in ISO 9001:2015.
But, mostly read the ISO 9001:2015 Quality Management Systems Standard book. Just do an overview until you understand the structure before you get into the details.
I would review the last 3 years of audit findings from your registrar. This will let you know if there are major problems lurking. Any findings will relate to the requirements in ISO 9001:2015.
But, mostly read the ISO 9001:2015 Quality Management Systems Standard book. Just do an overview until you understand the structure before you get into the details.
In addition to the above advice, I suggest you get your hands on a used copy of ISO 9001:2015 in Plain English. It goes through their ISO 9001 standard clause by clause and explains what it is about, yes in plain English. Read it front to back.
I suggest this book because it explains quality management systems while it explains the standard. With the possible exception of Design, your organization will have everything in there in some shape or form.
Once you have done these things, feel free to come back with more specific questions about what you find in your documentation.
I suggest this book because it explains quality management systems while it explains the standard. With the possible exception of Design, your organization will have everything in there in some shape or form.
Once you have done these things, feel free to come back with more specific questions about what you find in your documentation.
Randy
Super Moderator
Guess who has a copy?
You know I do.
outdoorsNW
Quite Involved in Discussions
After you are familiar with the 9001 standard, read the recent internal audit reports. Look for evidence of soft grading, such as many audits not having any non-conformances or serious problems being labeled opportunities for improvement. Soft grading can lead to external audit findings.
Take an internal auditing class if possible.
Follow-up on internal audit reports and see if reasonable actions were completed and implemented in response to nonconformances. See if the corrective actions are still used, and if not, is there a good reason why, such as a better method was implemented or data shows the corrective actions did not work as intended, in which case a different action should have been implemented. Almost always the actions need to be more than just retrain the operator.
Conduct some internal audits. Some audited processes should be selected on a random basis or because the process has not had an internal or external audit in a while. Choose a few more where there is reason to suspect possible 9001 nonconformances. But audit with an open mind and attention to what 9001 actually requires because sometimes the suspicion turns out to not be a non-conformance.
Usually, people talk about the problem areas and processes. If people talk about a process being difficult to perform, that might mean some people take shortcuts to minimize the difficulty. Find out what the known problem areas are. Look at internal audits and see how many of the problem areas people talk about have had an internal audit recently. Not all problem areas need an internal audit. Sometimes, such as an old machine that struggles to make good product, the problem is understood and may have an improvement in the works. If problem is primarily technical/engineering related rather than a failure to follow the process an internal audit may not find much. However, some technical problems are really the result of people not following the process and the requirements, in which case an internal audit is valuable. You may not know until you are done with the audit.
Take an internal auditing class if possible.
Follow-up on internal audit reports and see if reasonable actions were completed and implemented in response to nonconformances. See if the corrective actions are still used, and if not, is there a good reason why, such as a better method was implemented or data shows the corrective actions did not work as intended, in which case a different action should have been implemented. Almost always the actions need to be more than just retrain the operator.
Conduct some internal audits. Some audited processes should be selected on a random basis or because the process has not had an internal or external audit in a while. Choose a few more where there is reason to suspect possible 9001 nonconformances. But audit with an open mind and attention to what 9001 actually requires because sometimes the suspicion turns out to not be a non-conformance.
Usually, people talk about the problem areas and processes. If people talk about a process being difficult to perform, that might mean some people take shortcuts to minimize the difficulty. Find out what the known problem areas are. Look at internal audits and see how many of the problem areas people talk about have had an internal audit recently. Not all problem areas need an internal audit. Sometimes, such as an old machine that struggles to make good product, the problem is understood and may have an improvement in the works. If problem is primarily technical/engineering related rather than a failure to follow the process an internal audit may not find much. However, some technical problems are really the result of people not following the process and the requirements, in which case an internal audit is valuable. You may not know until you are done with the audit.
greatwhitebuffalo
Involved In Discussions
I found myself in a similar position some years ago, but I was charged with implementation of the system. What helped me understand in practical terms how we complied with the standard was to make tables with the standard's requirements on the left, compliance in the middle (yes / no column) and evidence of compliance on the right (how we comply). This table also helped guide me through our first audits. Some quality manuals are set up in a similar fashion, with the clauses listed and how the company complies. Take it slow and one day it will "click". This forum has been an invaluable resource.
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