Documentation for Health & Safety (OSHA) require ECO's?

M

Marquee05

#1
I would like the expertise of the people on this board on the subject of documents that require ECO's and those that don't. We are creating new OSHA documents such as "Fire & Earthquake Action Plan" and "Injury & Illness Prevention PLan" and "Innoculation for Hepatitis B" (for those who handle returned merchandise from hospitals). These are all HR documents so do they need to be formally approved through an ECO and do they belong to the Quality System? I don't think so. I believe that referencing ISO 13485:2003 section 6.4 is only an invitation to be audited - that opens a can of worms unnecessarily. I'm in favor of keeping the docs in HR and having them accessible to all employees electronically but our Regulatory person thinks they should be "controlled documents" and part of the Q system.

Anyone? :confused:

I'm the Documentation Specialist.
 
Elsmar Forum Sponsor
F

funkj - 2008

#2
I would put them in your QMS. Some auditors would consider them a type of WI that needs to be followed to stay safe. If they are not controlled with in your system how do you know if people are following the proper steps.

That is my two cents, but I am not familiar with your version of ISO.

At my previous employer we were attempting to integrate our EHS stuff, (things that you referenced above) with our TS system so that everything was under one "roof" and required a little less work to monitor and control.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#3
The ECO process isn't a quality system function, it is a document control function. Registering to one ISO standard or 12 of them makes no difference in this subject. Document change control can, and should be managed in one central process.

That's because the various standards have the same requirements: to decide what is important to control and why; how the records will be maintained; how and when they will be disposed of; how you will ensure information is kept current, and how you will keep old information for reference.

The documents you listed sound like they may have more than one set of requirements, because some may be required by law and others provide support for workplace health and safety maintenance. The documents that describe what is required and how you do things should have change control. Documents that show what has been done--records--should not get any changes once they are completed and filed.

I don't mean to preach to the choir, only show you that there really is little difference here between quality and safety system documentation management. So don't call it Quality Document Control. Just call it Document Control.
:2cents:
 

Doug Tropf

Quite Involved in Discussions
#4
I would like the expertise of the people on this board on the subject of documents that require ECO's and those that don't. We are creating new OSHA documents such as "Fire & Earthquake Action Plan" and "Injury & Illness Prevention PLan" and "Innoculation for Hepatitis B" (for those who handle returned merchandise from hospitals). These are all HR documents so do they need to be formally approved through an ECO and do they belong to the Quality System? I don't think so. I believe that referencing ISO 13485:2003 section 6.4 is only an invitation to be audited - that opens a can of worms unnecessarily. I'm in favor of keeping the docs in HR and having them accessible to all employees electronically but our Regulatory person thinks they should be "controlled documents" and part of the Q system.

Anyone? :confused:

I'm the Documentation Specialist.
Per ISO 14969, if product quality can be influenced by any of situations addressed in the OSHA documents you referenced, then they should be under the quality system umbrella.
 

Al Rosen

Staff member
Super Moderator
#5
An argument can be made on either side of this. There are those who would put everything under the QMS, but IMO I would keep it out. You may still want to control the documents, but not within the QMS.
 

Helmut Jilling

Auditor / Consultant
#6
I would like the expertise of the people on this board on the subject of documents that require ECO's and those that don't. We are creating new OSHA documents such as "Fire & Earthquake Action Plan" and "Injury & Illness Prevention PLan" and "Innoculation for Hepatitis B" (for those who handle returned merchandise from hospitals). These are all HR documents so do they need to be formally approved through an ECO and do they belong to the Quality System? I don't think so. I believe that referencing ISO 13485:2003 section 6.4 is only an invitation to be audited - that opens a can of worms unnecessarily. I'm in favor of keeping the docs in HR and having them accessible to all employees electronically but our Regulatory person thinks they should be "controlled documents" and part of the Q system.

Anyone? :confused:


I'm the Documentation Specialist.
As I have offered in other postings, I recommend all important documents should be controlled. If it is important that they be accurate and up to date, they need to be controlled.

If you buy that, then the question is not whether to control them, rather to what degree. Different kinds of documents can be controlled in different ways, depending on what is needed.

Try to keep it simple.
 

somashekar

Staff member
Super Moderator
#9
I would like the expertise of the people on this board on the subject of documents that require ECO's and those that don't. We are creating new OSHA documents such as "Fire & Earthquake Action Plan" and "Injury & Illness Prevention PLan" and "Innoculation for Hepatitis B" (for those who handle returned merchandise from hospitals). These are all HR documents so do they need to be formally approved through an ECO and do they belong to the Quality System? I don't think so. I believe that referencing ISO 13485:2003 section 6.4 is only an invitation to be audited - that opens a can of worms unnecessarily. I'm in favor of keeping the docs in HR and having them accessible to all employees electronically but our Regulatory person thinks they should be "controlled documents" and part of the Q system.

Anyone? :confused:

I'm the Documentation Specialist.
For sustaining and improving the process and its interactions, I would always address your type of issues within the QMS. I believe no process is so less important that you still want to adopt it but keep it out of the QMS.... Sooner or later that will turn out to be your weakest link. What you would be getting into perhaps will be a very good Integrated QMS
Wishing you good luck.....
 
J

joshua_sx1

#10
:2cents:
…first, if your ECO’s are engineering change orders that could affect your OHSA performances, definitely you have to control them…

…and I guess, if your management agrees to let their control under QMS, I don’t see any problem on that since you are going to control them anyway… and not to mention that the generic document requirements for QMS and OHSAS are the same…

(…just a thought, if they are engineering change orders, shouldn’t be they belong to engineering? :confused:)
 
Thread starter Similar threads Forum Replies Date
U HSE (Health, Safety and Environmental) Documents and Documentation Occupational Health & Safety Management Standards 1
T Safety & Health Documentation Responsibilities and Requirements (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Le Chiffre Health Canada to accept Summary Technical Documentation (STED) for Class III & IV ISO 13485:2016 - Medical Device Quality Management Systems 1
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
C Documentation hold during submissions? ISO 13485:2016 - Medical Device Quality Management Systems 0
K SOUP (Software of Unknown Provenance) Anomaly Documentation IEC 62304 - Medical Device Software Life Cycle Processes 2
C Gobys for operations documentation plan Oil and Gas Industry Standards and Regulations 4
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
C Documentation for items used for Design Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Documentation structure - Do I need Work Instructions? Document Control Systems, Procedures, Forms and Templates 23
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Robert Stanley Required Documentation Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
was named killer CLOUD BASED QUALITY DOCUMENTATION vs. SERVER BASED Document Control Systems, Procedures, Forms and Templates 5
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
K ITAR Visitor Documentation of Citizenship AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
R Design Verification Documentation ISO 13485:2016 - Medical Device Quality Management Systems 19
A Process Documentation for ISO 9001:2015 Internal Auditing 2
F Process Review - What is the ISO requirement for reviewing SOPs and quality documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
F ISO 17025:2017 mandatory documentation requirements ISO 17025 related Discussions 1
D Virtual Documentation via Master Flow Chart? Process Maps, Process Mapping and Turtle Diagrams 4
S Defining a Quality System from scratch - Preferred system and documentation names Document Control Systems, Procedures, Forms and Templates 4
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
F PPAP Documentation Control APQP and PPAP 8
V Every good documentation practice observation is an data integrity issue US Food and Drug Administration (FDA) 7
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
DuncanGibbons Documentation aerospace OEMs require with purchase of parts from manufacturers/suppliers Manufacturing and Related Processes 0
V What is the criteria to cite an good documentation practices observation as an data integrity related issue US Food and Drug Administration (FDA) 6
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
L ISO 9001:2015 standard documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N Time source for paper-based documentation (research nurses) US Food and Drug Administration (FDA) 1
W Documentation - Use of Addendum vs Amendment Document Control Systems, Procedures, Forms and Templates 1
I What level of change in documentation requires re-training? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
D QMS Documentation Process - I want to put all the Process SOPs to a QMS system Document Control Systems, Procedures, Forms and Templates 3
T QMS - Documentation Cloud Storage EU Medical Device Regulations 0
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
B Quality Management System documentation identification Document Control Systems, Procedures, Forms and Templates 11
J Training documentation - ISO 13485 audit and the auditor had questions General Auditing Discussions 7
D Documentation requirements for the new Medical Device Regulations (2019) CE Marking (Conformité Européene) / CB Scheme 5
Ashok sunder ISO 45001:2018 Documentation template Occupational Health & Safety Management Standards 4
M Informational BSI – MDR Documentation Submissions Best Practices Guidelines Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom