OK EC friends, I'm back.
If you've seen some of my earlier posts you may remember , but here's a bit of history.
In July 2019 I came to a small company that had their first AS9100 certification audit in Jan 2019 (After four months of preparation and with the aid of an SME / consultant that based the QMS on a generic "canned" AS9100 package.). When I came aboard the individual assigned the Quality rep responsibilities had spent much, much more time in the field performing his "old" job (Field Tech) than actually supporting the QMS. Consequently we were < 6 months from our first surveillance audit and had very little to support compliance to the AS requirements. Management mandated that the current rep would no longer be involved in the off-site activities that had kept him from focusing on the QMS, and of course, they hired me to help. I was fortunate to have had 20+ years in a Quality Assurance post with one company, a good part of that time we were AS certified (first a little bit of B, then to C) , but I had been performing in a different role the last few years (since 2015). The QMS that I had managed was developed over years (and I had the advantage of working with the same consultant during the entire time) so a lot of what I learned and facilitated was specific to that company / industry. I really didn't know how much I didn't know until I began this post. We recently completed the surveillance audit and did pretty good.
At any rate when this company submitted the stage 1 information prior to certification, they identified five "Processes" - Management & Support Processes, Customer Management, Design Management, Purchasing / Supplier Management, and Production Management.
However another part of the submission package, titled "Process Identification" came with the following instructions:
" This chart identifies what AS9100/AS9120 requirements are addressed in which processes and helps to assure that all AS9100/AS9120 requirements are addressed in your system. Please ensure that all clauses have been covered and identified to the relevant processes. The processes identified on this table should agree with the processes identified on your process map or in your manual. INSTRUCTIONS: Fill in the table below with the processes identified by your organization in the left hand column and the Process Owner and the procedure/work instruction/flowchart that describes the process and the metric/measure used to determine effectiveness of the process. Then in the right-hand columns place an “x” to indicate the AS9100/AS9120 clauses which are addressed by that process. "
And a table with the following fields 1) Process 2) Process Owner 3) Procedure / flowchart 4) Process Effectiveness Metric, as well as columns for each AS clause, 4.1, 4.2, etc. . The following is an example of how this form was filled-out : First entry - The Quality rep filled in field 1 with "Process : P-400 Organizational Context (Our documented procedure) and nothing in the "Procedure / flowchart" or "Process Effectiveness Metric" fields, then checked the columns for 4.1, 4.2, 4.3, and 4.4 - (these are the AS clauses that this procedure addresses). The same pattern was followed for every one of our procedures ("Process : P-500 Leadership" with 5.1, 5.2, & 5.3 columns "checked') and so on for 29 documented procedures. I'm not sure that this is the intended use for this "form", but I suspect it was not - maybe I'm wrong?
So, to the point of my entry today (Sorry it took so long but I felt like it was important to provide some background.) After I came aboard, one of the things that needed addressed was Internal Audits. I put together a tailored generic "checklist" and conducted and recorded an internal audit pretty much based on departmental responsibilities / clauses (I know...), and it was enough to allow the auditor not to write a finding, although he did note an opportunity for improvement. Now I'd like to schedule process based audits, using the processes noted in paragraph 1, above, but I'm having a hard time communicating this to the Q rep as he is certain that a procedure equals a process. I feel that multiple procedures may support a process, for example our Management and Support Processes process may be supported by our procedure P-400 Organizational Context, and by our procedure P-930 Management Review (just to name a couple) and I plan to use standard AND procedure interview questions.
I may be way off base and I'd sure like to hear what folks in the EC community have to say.
If you've seen some of my earlier posts you may remember , but here's a bit of history.
In July 2019 I came to a small company that had their first AS9100 certification audit in Jan 2019 (After four months of preparation and with the aid of an SME / consultant that based the QMS on a generic "canned" AS9100 package.). When I came aboard the individual assigned the Quality rep responsibilities had spent much, much more time in the field performing his "old" job (Field Tech) than actually supporting the QMS. Consequently we were < 6 months from our first surveillance audit and had very little to support compliance to the AS requirements. Management mandated that the current rep would no longer be involved in the off-site activities that had kept him from focusing on the QMS, and of course, they hired me to help. I was fortunate to have had 20+ years in a Quality Assurance post with one company, a good part of that time we were AS certified (first a little bit of B, then to C) , but I had been performing in a different role the last few years (since 2015). The QMS that I had managed was developed over years (and I had the advantage of working with the same consultant during the entire time) so a lot of what I learned and facilitated was specific to that company / industry. I really didn't know how much I didn't know until I began this post. We recently completed the surveillance audit and did pretty good.
At any rate when this company submitted the stage 1 information prior to certification, they identified five "Processes" - Management & Support Processes, Customer Management, Design Management, Purchasing / Supplier Management, and Production Management.
However another part of the submission package, titled "Process Identification" came with the following instructions:
" This chart identifies what AS9100/AS9120 requirements are addressed in which processes and helps to assure that all AS9100/AS9120 requirements are addressed in your system. Please ensure that all clauses have been covered and identified to the relevant processes. The processes identified on this table should agree with the processes identified on your process map or in your manual. INSTRUCTIONS: Fill in the table below with the processes identified by your organization in the left hand column and the Process Owner and the procedure/work instruction/flowchart that describes the process and the metric/measure used to determine effectiveness of the process. Then in the right-hand columns place an “x” to indicate the AS9100/AS9120 clauses which are addressed by that process. "
And a table with the following fields 1) Process 2) Process Owner 3) Procedure / flowchart 4) Process Effectiveness Metric, as well as columns for each AS clause, 4.1, 4.2, etc. . The following is an example of how this form was filled-out : First entry - The Quality rep filled in field 1 with "Process : P-400 Organizational Context (Our documented procedure) and nothing in the "Procedure / flowchart" or "Process Effectiveness Metric" fields, then checked the columns for 4.1, 4.2, 4.3, and 4.4 - (these are the AS clauses that this procedure addresses). The same pattern was followed for every one of our procedures ("Process : P-500 Leadership" with 5.1, 5.2, & 5.3 columns "checked') and so on for 29 documented procedures. I'm not sure that this is the intended use for this "form", but I suspect it was not - maybe I'm wrong?
So, to the point of my entry today (Sorry it took so long but I felt like it was important to provide some background.) After I came aboard, one of the things that needed addressed was Internal Audits. I put together a tailored generic "checklist" and conducted and recorded an internal audit pretty much based on departmental responsibilities / clauses (I know...), and it was enough to allow the auditor not to write a finding, although he did note an opportunity for improvement. Now I'd like to schedule process based audits, using the processes noted in paragraph 1, above, but I'm having a hard time communicating this to the Q rep as he is certain that a procedure equals a process. I feel that multiple procedures may support a process, for example our Management and Support Processes process may be supported by our procedure P-400 Organizational Context, and by our procedure P-930 Management Review (just to name a couple) and I plan to use standard AND procedure interview questions.
I may be way off base and I'd sure like to hear what folks in the EC community have to say.
