Inclusion of company safety manual and procedures in QMS

Q

qwetwo

#1
We are an AS9100 and NADCAP certified company. I have always been of the school that says not to mix these two programs. My logic lies in (1) the fact that OSHA and its state derivatives have enough structure in and of themselves, and, (2) inclusion of the safety program goes beyond the intent of AS9100, although safety could be interpreted as part of work environment. Inclusion also makes the entire safety program auditable.

I would be curious to learn how others feel about blending the two efforts, and from anyone who has such a blended system regarding its value to the company.

Thanks in advance
 
Elsmar Forum Sponsor

RoxaneB

Super Moderator
Super Moderator
#2
We blend where I am...you'll find many people in the Cove who are strong advocates of an integrated system or BMS (Business Management System).

My company has, where possible, integrated Operational/Quality, Health & Safety and Environment into our standards (documentation) and training. Why?

Because while it is easier to understand a concept when it is isolated (sometimes referred to as silo thinking...you study electrons and I'll study neutrons and then we get together later and compare notes), when it comes to training and developing a system that provides value to an organization, one-stop shopping may be the way to go.

I'm not saying that it works for all organizations...some cultures may not be aligned with an integrated system...but for us, it worked because of how we communicate.

We don't welcome someone on their first day and say "Here, let us show you how to do your job." And on the 2nd day, "Here, let us show you how to be safe." And on the 3rd day, "Here, let us show you how to protect the environment."

We actually say, "Welcome! Let us show you how to do your job so that you're safe, the environment is safe and the requirements are met." We show them how to do their job properly in all aspects...not one aspect at a time.

But like I said above...just because it works for us does not mean that it will work for every organization.
 
C

crendfrey

#3
I agree with RCBeyette.
Our Safety Manual is attached as an addendum (along with our Employee Handbook) to our policy procedures and work instructions as it is referred to in our work instructions routinely.
I would have integrated it fully but I am required to send it to certain customers for approval to be allowed on site.
We are 17025:2005 calibration lab. As REBeyette says, it is truly very difficult to teach someone how to maneuver a 2000Lb weight (or 15 of them at a time) without safety as a primary issue.
Also having them attached as such, basically requires me to review and revise during annual internal audits. This is a good thing I think.

hope this helps a little bit
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
I'm also of the school that they should be in one system and have always designed my systems as such.

One reason is because in more than one job QA and Compliance were both under my unbrella.
But even if they were not, why have two (or more) document control systems? OSHA definately requires some written procedures. Just separate them into a subsection or supplement or something of your Quality (or Business) Management System but don't create more work for yourself by running multiple systems.
And there are crossovers. OSHA and any QMS require training systems.

And I think that "inclusion makes it auditable" is somewhat faulty logic...
I've had a system that was audited by customers and the FDA and neither even so much as glanced at the safety procedures even thought they all had access to the full index. Just as OSHA and EPA didn't give a hoot about our quality policy when they popped in for a surprise visit.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Don't let the auditor wander out of their scope.

Discordian said:
And I think that "inclusion makes it auditable" is somewhat faulty logic...
I've had a system that was audited by customers and the FDA and neither even so much as glanced at the safety procedures even thought they all had access to the full index. Just as OSHA and EPA didn't give a hoot about our quality policy when they popped in for a surprise visit.
:agree1: Exactly. Audits have "scope of coverage". I had made a similar point (as it pertains to 3rd party auditors) in this post.
 
S

spomagnum

#6
I am the Safety and Quality Manager and keep them seperate and note or refer to appendixes or rules when needed. Because the safety of the employees is paramount, the quality of the job is based on how safely it can be done. OSHA does not care about Quality when they come in and vice versa. They can tell when a company is putting one over the other OSHA or state osha, don't say it but hey need to know your company is putting the employees safety above all else.

If you can convince a safety auditor your safety is paramount you are much less likey to get any fines at all. IF you can show the auditor your 100% involved in anything they find as a Serious violation the odds of getting it dropped to a general or written off completely are much higher.

You can combine them and that's easy but they should be seperate.

I keep seperate. When the quality auditors come in whoever it may be, assume already that safety is over quality and do pay attention to procedures regarding safety within the operation or process. Auditors for quality or customers all understand safety should come first so far all understand what work is safety orientated and things are done the way the are so work can proceeed as scheduled.

If a quality auditor comes in and does not ask why things are done the way they are. It's not a quality audit it's a productivity audit.
 
K

kgott

#7
I am the Safety and Quality Manager and keep them seperate and note or refer to appendixes or rules when needed. Because the safety of the employees is paramount, the quality of the job is based on how safely it can be done. OSHA does not care about Quality when they come in and vice versa. They can tell when a company is putting one over the other OSHA or state osha, don't say it but hey need to know your company is putting the employees safety above all else.

If you can convince a safety auditor your safety is paramount you are much less likey to get any fines at all. IF you can show the auditor your 100% involved in anything they find as a Serious violation the odds of getting it dropped to a general or written off completely are much higher.

You can combine them and that's easy but they should be seperate.

I keep seperate. When the quality auditors come in whoever it may be, assume already that safety is over quality and do pay attention to procedures regarding safety within the operation or process. Auditors for quality or customers all understand safety should come first so far all understand what work is safety orientated and things are done the way the are so work can proceeed as scheduled.

If a quality auditor comes in and does not ask why things are done the way they are. It's not a quality audit it's a productivity audit.
To take up RcBeyette's point, the process of transforming customer inputs into customer deliverables involves people doing work and consuming finite resources. It makes sense that the safety of people is safeguared when they they do the work thats required to be done and the minimum amount of finite resources are used and so make the product realisation process as efficient as possible.

You can seperate safety, quality and environmental issues on paper but you can't do that when it comes creating goods and services. To try and do so indicates that there is a missalignment between how work get done and an how the busienss management systems are percieved to work on as depicted on paper.
 

somashekar

Staff member
Super Moderator
#8
Each of these standards have their own specific focus area. When we embrace a standard, we commit to meet the requirements of that standard by mapping our operations with that standard's requirements.
But beyond this we can also see that all these standards embrace the same methodology for application of that management system ...
To Plan -- Do -- Check -- and Act, in a way to maintain and continually improve that system.
In the normal working, it seems highly false to embrace each of these separately. The thinking, processing and doing activities must be done with all the focus areas in tandem. The key is integration, and the essence is to operate as an integrated management system.
Our worry always crops up from the audit view point and this drives all activities to be kept separate and managed, thinking that the organization is operating towards audit requirement.
No.
Organization operate towards meeting business requirements, and these can be quality, environmental, safety, and anything more. Just like the various spices cooked together gives the flavor and taste, we must blend and cook them together to be effective and enjoy the organization working.
Such a dimension thinking has to be inculcated into the organization and this is the top management area. When this is lacking, the directions down gets unclear and compartments become strong, only running behind successfully completing audits rather than seeing success and progress.
Leave the audit to auditors. They will know the scope of audit and keep within that. As an organization we must focus on good understanding and integration of scope to work in harmony. Integrated management is way to go ~~~~~
 

Randy

Super Moderator
#9
I hate agreeing with Sidney:D, but, Scope of coverage is absolutely correct. Right now, this week, I have done 3 seperate "audits" of different types of the same organization using the same documentation and identical activities (Manual, Policy, level 1 and some level 2 procedures, internal audit, management review, etc..)

Audits
1...QMS recertification
2...EMS surveillance
3...OHS Stage 1

Each audit was conducted on specific and seperate dates (actually the OHS Stage 1 is tomorrow) and had different objectives & scopes

Each had or will have had individual opening & closing meetings

Each had a seperate audit plan

Each will have a seperate audit report

Now next year (of course fully dependant upon success in OHS Stage 1 & 2) all 3 systems will be audited concurrrently as integrated systems...1 plan, 1 report
 
Thread starter Similar threads Forum Replies Date
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
I Inclusion of 7.3 design and development (previously excluded) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S ISO/IEC Guide 51: 1999, Safety Aspects - Guidelines for their inclusion in standards Food Safety - ISO 22000, HACCP (21 CFR 120) 4
V Coverage of Process Failures in dFMEA (Scope/Boundaries for Inclusion) & vice versa Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
F Quality Manual Inclusion and Exclusion Justifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Z Supplier Scorecard Inclusion of Corrective Actions Supplier Quality Assurance and other Supplier Issues 3
D Sales targets (KPI's) and their inclusion in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Q MDD inclusion in Quality Policy - MDD Annex 5, 3.2 was referenced ISO 13485:2016 - Medical Device Quality Management Systems 3
S The essential criteria for inclusion in a test method Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
D PPAP for Electronics - Inclusion of Dimensional Data and Material Specifications APQP and PPAP 2
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
F IVD registration in EU - Northern Ireland based company EU Medical Device Regulations 0
W Where does a coatings and paint company fall in IATF? IATF 16949 - Automotive Quality Systems Standard 5
A AS9100D - Clause 8.1 Operation - Coating service company AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
O Informational Ford Motor Company Customer Specific Requirements for IATF 16949:2016 - 08 Jan 2021 Customer and Company Specific Requirements 0
L Have been purchased by a corporate company ISO 13485:2016 - Medical Device Quality Management Systems 7
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
lanley liao What shoud i do if our company top management has been changed. Oil and Gas Industry Standards and Regulations 8
S Malcolm Baldrige Company Dashboard Quality Tools, Improvement and Analysis 3
T IATF Rules for sharing production space with another company IATF 16949 - Automotive Quality Systems Standard 10
J Leveraging another company's ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
R MDEL and company affiliate Canada Medical Device Regulations 0
E Our company is planning to file MDD not MDR next month. Do we require to show chemical characterization report ? CE Marking (Conformité Européene) / CB Scheme 2
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
E Contract manufacturer FDA requirements foreign company US Food and Drug Administration (FDA) 6
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
M IT validation for a paper based MD repair company QMS ISO 13485:2016 - Medical Device Quality Management Systems 6
M QMS for a repair/servicing company ISO 13485:2016 - Medical Device Quality Management Systems 2
C Internal Audits in a tiny Dx Company Internal Auditing 33
T ISO 13485 - 5.5.1 Responsibility and authority - Small Company Independence ISO 13485:2016 - Medical Device Quality Management Systems 13
F Quality manual for trading company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Implementing the PRRC role in a company EU Medical Device Regulations 7
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 17
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T EQMS for small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 18
qualprod Corona virus Contingency plan - What have you done in your company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 11
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
L Contracted Manufacture Company wanting to be able to design and manufacture own product. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D ISO9001 for one man company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11

Similar threads

Top Bottom