Handling External Audits with Internal Vacations

H

HSSE Auditor

#31
While I agree to a point, I disagree to a point as well. If he were to leave today it would be a shock but we would prevail. We may not introduce new products for awhile, but we'd still be in business. We aren't sitting over here biting our nails giving his guy everything he asks for. He understands the situation and would be here, but as with everything there is always some conflict.

We are a small company, theres nothing the Engineering manager knows that cannot be taught to another individual. Heck, the audit is 3 months away. Is everyone saying to reschedule an audit that far out because of one person being on vacation? Our processes aren't that complicated that any competent person couldn't learn.
Me thinks you complain too much. This audit was scheduled at a time that you knew folks would be on vacation. Why was it scheduled for a time when folks were on vacation????
 
Elsmar Forum Sponsor
N

noboost4you

#32
Our first Internal Audit is scheduled for next month. We'll be sure to get their input as well.
 

Jim Wynne

Staff member
Admin
#33
We are a small company, theres nothing the Engineering manager knows that cannot be taught to another individual.
Then you can have him teach everything he knows to another person, and then get rid of him. Or do you think that he might have knowledge that can't be transferred as easily as you seem to think it can?

Heck, the audit is 3 months away. Is everyone saying to reschedule an audit that far out because of one person being on vacation? Our processes aren't that complicated that any competent person couldn't learn.
It makes me wonder why you even asked the question in the first place then. If you feel confident that the auditor's questions will be answered accurately by a surrogate, then there should be no problem. The auditor will be looking mainly for information, not people.
 
N

noboost4you

#35
Then you can have him teach everything he knows to another person, and then get rid of him. Or do you think that he might have knowledge that can't be transferred as easily as you seem to think it can?



It makes me wonder why you even asked the question in the first place then. If you feel confident that the auditor's questions will be answered accurately by a surrogate, then there should be no problem. The auditor will be looking mainly for information, not people.
I wanted to get a feel for what other people think and maybe even gone through themselves. It was basically one of those questions where there are a few options available, but no matter what anyone said we're going with what we had originally planned to do.

And after reading all the responses, which I'm grateful for, we'll continue on with what we had originally planned. Simply because there was no overwhelming evidence of everyone suggesting to reschedule the audit. I suppose it was a tough question to answer because no one here knows our company and how everything is handled. To some companies, it may be easy to reschedule audits or vacations and to others it may be easier to train someone. It can't hurt to have additional personnel knowledgable of certain sectors within the organization.

Our Internal Audit is next month. Perhaps it would be a good time to 'test' the trainee in that situation with the manager closely monitoring. Or have the trainee closely monitor the manager.

Thanks everyone for your input. Everyone's responses were thought through and helped in one way or another.
 
#36
Part of being a professional (the engineering manager) is accepting that sometimes you may have to change (change, not drop altogether) plans for work priorities.
seems to me 4 months is plenty of time to reschedule a vacation for something as important as a registration audit.
We are also having a registration audit (ISO9001) in August and all management has been told that no vacation will be approved for that week. In addition I have notified my staff that I will not approve vacation for the week prior.
The owner rescheduled some vacation time because of this.
Wow, Discordian, I've rarely seen you stray so far from my way of thinking! "Screw those audits, I've had my vacation scheduled since January 1!" = My thinking and the thinking of everyone else with enough experience to get 3 or 4 weeks scheduled vacation every year. Vacations are not some priveledge to be granted at the behest of some high muckity-muck. They are well deserved recharge times for your best people. I would never screw my best people out of a long awaited vacation! I have a TS audit that was scheduled for the week of June 18-22, between the registrar and I, two weeks after I scheduled June 22 off. The audit will take place on any two days that week except June 22. This vacation day is pointless if rescheduled because that day is the only day that some very important people in my life (way more important than my job!) will be gathered together.

I don't understand why you feel the need to have "everyone on deck" for an external audit, even a registration audit. Companies run without 100% of the people every day, every week. People get sick or take vacation. Are you telling me that you can't pass a registration audit without everyone present? I can understand that you don't want the entire management team to cut and run the week of the audit but do you want to make enemies in management if you've got a couple that booked flights, hotels, reservations and plans for a week with their family last October?
We are a small company, theres nothing the Engineering manager knows that cannot be taught to another individual. Heck, the audit is 3 months away. Is everyone saying to reschedule an audit that far out because of one person being on vacation? Our processes aren't that complicated that any competent person couldn't learn.
We're a small company, too. Our auditor likes to talk to the Engineering Manager every time he audits. He doesn't always get to do so. I firmly believe that asking some hard questions a little farther down the line gives him, and us, the confidence that our enterprise is not too dependent on any single person.
Me thinks you complain too much. This audit was scheduled at a time that you knew folks would be on vacation. Why was it scheduled for a time when folks were on vacation????
I'm not privy to everyone's schedule 12 or even 6 months out. We schedule, we adapt. This is not that big a deal!
.. Simply because there was no overwhelming evidence of everyone suggesting to reschedule the audit. Our Internal Audit is next month. Perhaps it would be a good time to 'test' the trainee in that situation with the manager closely monitoring. Or have the trainee closely monitor the manager.
Don't reschedule. Get a handle on the gaps between manager and trainee knowledge during Internal Audit so you can fill them before the External Audit. Once again, I believe that a robust QMS system should be able to handle this kind of thing without resorting to vacation mangling or excessive wrangling over audit dates.
 
Last edited:

ScottK

Not out of the crisis
Staff member
Super Moderator
#38
Wow, Discordian, I've rarely seen you stray so far from my way of thinking! "Screw those audits, I've had my vacation scheduled since January 1!" = My thinking and the thinking of everyone else with enough experience to get 3 or 4 weeks scheduled vacation every year. Vacations are not some priveledge to be granted at the behest of some high muckity-muck. They are well deserved recharge times for your best people. I would never screw my best people out of a long awaited vacation! I have a TS audit that was scheduled for the week of June 18-22, between the registrar and I, two weeks after I scheduled June 22 off. The audit will take place on any two days that week except June 22. This vacation day is pointless if rescheduled because that day is the only day that some very important people in my life (way more important than my job!) will be gathered together.

I don't understand why you feel the need to have "everyone on deck" for an external audit, even a registration audit. Companies run without 100% of the people every day, every week. People get sick or take vacation. Are you telling me that you can't pass a registration audit without everyone present? I can understand that you don't want the entire management team to cut and run the week of the audit but do you want to make enemies in management if you've got a couple that booked flights, hotels, reservations and plans for a week with their family last October?
We're a small company, too. Our auditor likes to talk to the Engineering Manager every time he audits. He doesn't always get to do so. I firmly believe that asking some hard questions a little farther down the line gives him, and us, the confidence that our enterprise is not too dependent on any single person.
I'm not privy to everyone's schedule 12 or even 6 months out. We schedule, we adapt. This is not that big a deal!
Don't reschedule. Get a handle on the gaps between manager and trainee knowledge during Internal Audit so you can fill them before the External Audit. Once again, I believe that a robust QMS system should be able to handle this kind of thing without resorting to vacation mangling or excessive wrangling over audit dates.
It's part of being a Discordian - I can't be too predictable. ;)

understand - I would not screw anyone out of a vacation. never. would I ask them to reschedule? absolutely. If they can't it's one thing, if they won't it's another.

I would try to reschedule the audit first though.

and as far as having all hands on deck - a registration audit is (or should be) a one time thing. Everyone in the company should experience it. For a surveillance or re-registration I'd feel differently as the system should be set up to run without certain people needing to be there.
So my interest is not in passing or failing the audit, but for the experience for the people. They put the effort into it, why miss it? It's like blowing off your high school graduation.
 
#39
understand - I would not screw anyone out of a vacation. never. would I ask them to reschedule? absolutely. If they can't it's one thing, if they won't it's another.
So my interest is not in passing or failing the audit, but for the experience for the people. They put the effort into it, why miss it? It's like blowing off your high school graduation.
An erudite answer as usual, Discord...
I can't reschedule my vacation because I will miss an immutable event. I won't reschedule my vacation because it's been planned for 12 months, you came up with this alleged urgent need for my time last week, and you won't pay for the deposits, rescheduling fees, and other losses that I will suffer.

Our president was absent for all but the first 10 minutes of our registration audit. He had way more important things to do...like negotiating for some new business. QMS registration is irrelevant if you don't have customers...and your customers don't care if your audit is this week.

BTW, my brother missed his high school graduation. In fact, I'm pretty sure he doesn't have a high school diploma. He does have a BA in Psychology, an MS in Child Psychology and a Ph.D in Child and Family Counseling. He runs the state sponsored program for the general mental welfare of the greater Cody, Wyoming area. He has probably made sure that more traumatized children will become well-adjusted and productive members of society than you and I have even met. Some things are actually important and some things are important because we think they are important.
 
S

somerqc

#40
I never thought of myself as a hard-nose manager until this discussion took place.

We knew months in advance of when our registration audit was.

Granted, approvals took place almost a year prior, however, key personnel were informed that they would not have vacations approved that were within 4 weeks prior to the registration audit.

Based on responses I am seeing here, this would be considered draconian in many places. I consider it a perfectly reasonable request. To think, I am probably one of the younger ones here!
 
Thread starter Similar threads Forum Replies Date
Douglas E. Purdy Handling of ISO Interpretations - Are you controlling them as External Documents? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
S Advice on how to reduce overhead of handling non-conforming material Nonconformance and Corrective Action 7
B Handling lower detection limits for SPC and process performance Statistical Analysis Tools, Techniques and SPC 1
A ISO 10002:2018 Checklist Needed (Complaints Handling) Customer Complaints 5
G Handling Unpacked (Additive Chemical) Product For Automotive Applications IATF 16949 - Automotive Quality Systems Standard 3
A Handling of contaminated medical equipment Other Medical Device and Orthopedic Related Topics 0
B Procedures for Complaint Handling and Post Market Surveillance EU Medical Device Regulations 7
J KPIs or Metrics to Measure a New Complaint Handling Process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
shimonv Rigid rules for handling supplier audit findings ISO 13485:2016 - Medical Device Quality Management Systems 11
Jimmy123 Handling nonfunctional requirements in DFMEA FMEA and Control Plans 5
F Component Molding and Over-molding - Handling Resin Inventory Manufacturing and Related Processes 2
Q Handling Off-the-Shelf Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
V Handling open points in design reviews 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
P HVAC System vs Air Handling Unit (AHU) - Differences Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L GMDN code wanted - Software for handling records Service Industry Specific Topics 9
L Handling Sort/Return Requests Customer Complaints 8
S Document Handling during an Audit General Auditing Discussions 6
S Handling Cost of Sales requests for Customer Quality Manager and Management Related Issues 2
Q AS9100/AS1180-1 - Handling of Equipment and Calibration Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
M Complaint Handling Responsibilities for a Design Partner - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 9
S Merging Post Market Surveillance and Complaint Handling ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 9001 Ergonomics and Manual Handling Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Suggestions requested on handling batch record papers exposed to hormonal products Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
A Production and Post-Production and Complaint Handling ISO 14971 - Medical Device Risk Management 2
C What's Your Process for handling rush jobs, urgent or priority orders ? Manufacturing and Related Processes 6
A Medical Device Handling AFTER the device's specified lifetime has expired 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Handling of Obsolete Material Work Instruction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Risk Management, complaint handling and CAPA system ISO 14971 - Medical Device Risk Management 5
W Aerospace Materials Handling Training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
V Handling decomissioned line/equipment during 1st time product-based inspection US Food and Drug Administration (FDA) 1
D Complaint Handling Call Centers ISO 13485:2016 - Medical Device Quality Management Systems 7
W Contract Initial Importer and Order Handling for a Class I Medical Device Service Industry Specific Topics 2
W SOP on Handling of HCl (Hydrochloric Acid) Document Control Systems, Procedures, Forms and Templates 5
A Handling Normal Capacitor Production Fallout AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K Procedure for Handling of Customer Supplied Material (AS9100 Requirements) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M Procedure for Handling Customer Return Part (Defective Part Return) IATF 16949 - Automotive Quality Systems Standard 1
M Manufacturer's handling of Distributor's Historical Complaint Records US Food and Drug Administration (FDA) 5
C Anyone have experience handling Feed Safety Management System (GMP+B2)? Other ISO and International Standards and European Regulations 1
V ISO10002:2004 (Guidelines for Handling Customer Complaints) Self Assessment Checklist Customer Complaints 5
V Ensuring Improvement and Handling Change FMEA and Control Plans 4
S Handling Out-of-Specification Results: FDA's guidance for the industry Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 12
M Internal Warehouse Handling - A Reverse Logistic Case! Process Maps, Process Mapping and Turtle Diagrams 6
C Corrective Action and Preventive Action for Operator Error (Cosmetic - Handling) Preventive Action and Continuous Improvement 15
S PCB Handling Requirements - What to do if we drop a PCB during the assembly Manufacturing and Related Processes 4
M Raw Material Handling & Mixing in Plastic Injection Moulding Manufacturing and Related Processes 5
C Safe Handling of Non-Device Refurbished Medical Equipment US Food and Drug Administration (FDA) 3
Y Handling of Potentially Biohazard Material - Alcohol Cleaning Procedure ISO 13485:2016 - Medical Device Quality Management Systems 12
R Use of Automated Liquid Handling Robot for a PCR based Assay CE Marking (Conformité Européene) / CB Scheme 2
R Storage Procedure per NQA 1 Storage and Handling Requirements Document Control Systems, Procedures, Forms and Templates 6

Similar threads

Top Bottom