[QMS] Identification and Evaluation of Aspects, Impacts and Risks...

x-files

Involved In Discussions
#1
Hi,

At first we had an EMS procedure to identify "Aspects, Impacts and Risks" with appropriate methodologies for evaluation (we've separated methodology for "everyday" scenarios, and methodology for potential (risk) scenarios). Generally, for significant Risks we make Plans for reactions, and for significant "everyday" scenarios we make goals/targets.

Then, we (obviously) find out that OH&S has the very similar requirements, and that many EMS "Aspects, Impacts and Risks" are directly related to OH&S (what is a risk to environment, many times could be a risk to humans safety also, etc).

Finally, with PAS 99 in mind, we want to have ONE procedure to cover "Identification and evaluation of Aspects, Impacts and Risks", with QMS included, besides EMS and OH&S.

Basically, in the draft working version of "Aspects, Impacts and Risks" form, we've created a new column "Management system", where we want to highlight to what managements system is "Aspect, Impact or Risk" related to. Sometimes, its only EMS, sometimes it's only OH&S, and sometimes it's a combination of all three integrated systems.

First question is, are we on a good track with decision to integrate "Aspects, Impacts and Risks" for all our management systems? Are there any side-effects we should be aware of?

Second question is, what is a good direction to think of "QMS aspects/impacts/risks"?

For example, we have many purchasing in a year. Maybe few thousands. Some of purchasing failures are not significant, but some of purchasing failures could have enormous negative impacts. Further, poor maintenance of some devices is not so relevant, but on the other side, poor maintenance of some other devices could have immense impacts to business.

As you probably know, we in Serbia had epic floods these days. Fortunately, the dam managed to stop the high river level, which is literally near the powerplant. But (on hard way) we've discovered another risk. The dam is not of appropriate height and capacity 10 km far from our powerplant, and the river could in one day or two, soak electric field.

Could all that be QMS aspect/impact/risk?


Best Regards,
Vladimir Stefanovic
 
Elsmar Forum Sponsor

kgott

Quite Involved in Discussions
#2
Yes; your are on the right track because you are thinking in a holistic or global way about these things.

It will however require a lot of thinking as I have thought similar things myself but I have not been successful, at least yet, in working out how to make it work in some way so I'm interested in how you get on with it.

Impacts of unwanted events or unwanted outcomes will ultimately have have an environmental aspect or impact.

Inefficiency and ineffectiveness is not in itself a waste until it's translated into money and other types of waste. The same goes for intangible resources such as time and effort.
 

x-files

Involved In Discussions
#3
Yes; your are on the right track because you are thinking in a holistic or global way about these things.

It will however require a lot of thinking as I have thought similar things myself but I have not been successful, at least yet, in working out how to make it work in some way so I'm interested in how you get on with it.

Impacts of unwanted events or unwanted outcomes will ultimately have have an environmental aspect or impact.

Inefficiency and ineffectiveness is not in itself a waste until it's translated into money and other types of waste. The same goes for intangible resources such as time and effort.
http://elsmar.com/Forums/showpost.php?p=574745&postcount=6
 
Thread starter Similar threads Forum Replies Date
M Informational Is Identification of Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 87
DuncanGibbons Enterprise Architecture for QMS Conceptualization AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
S Class I MDR Article 10 – QMS EU Medical Device Regulations 1
I Drupal for QMS Quality Tools, Improvement and Analysis 26
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Validation Records - Very young QMS Qualification and Validation (including 21 CFR Part 11) 2
E Sharepoint for ISO 13485 QMS for small IVD company ISO 13485:2016 - Medical Device Quality Management Systems 7
GreatNate Where to get a KPI dashboard for QMS processes Quality Tools, Improvement and Analysis 5
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 2
U QMS for medical device startups ISO 13485:2016 - Medical Device Quality Management Systems 11
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
B Record Management - Does the QMS need to control templates of records? Records and Data - Quality, Legal and Other Evidence 17
D How do I promote my QMS? ISO 13485:2016 - Medical Device Quality Management Systems 5
I Questions to ask when auditing for Organizational Leadership and Planning for the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C QMS Document Management Software Recommendations Quality Assurance and Compliance Software Tools and Solutions 15
R QMS Standard appilications on different Defense Sector Quality Management System (QMS) Manuals 1
O ISO 9001 new certification advice request - Develop a QMS from scratch ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
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
R ISO 13485 QMS Implementation Training ISO 13485:2016 - Medical Device Quality Management Systems 7
B We need a QMS: file-based templates or software Other Medical Device Related Standards 23
H QMS Software Recommendation (US based, Hemp) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D How to Identify the Risks and Opportunities required for QMS Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Benefits of electronic QMS software Software Quality Assurance 5
D Why are pharma companies automating QMS systems? Quality Management System (QMS) Manuals 2
dgrainger QMS for device "use" in a Health Institution? EU Medical Device Regulations 7
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
R Approvals on QMS Documents - ISO 13485 Requirements Document Control Systems, Procedures, Forms and Templates 2
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 14
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 22
R ISO 13485 QMS sequence of implementation ISO 13485:2016 - Medical Device Quality Management Systems 4
S Is Annual QMS Training Required? ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
Dean Bell QMS Content for one-man consultancy Consultants and Consulting 19
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
I Is this a Major AS9100 QMS change - Quality Concerns AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
R ISO 13485 purchasing QMS and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
lifehealer ISO 9001 QMS VS ISO 41001 FMS Quality Management System (QMS) Manuals 7
L Audit boundaries - Is a Registrar permitted to audit a company's QMS by visiting their suppliers? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 26
A IRCA QMS Foundation Courses India ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 3
T Risk analysis of QMS software - Validating software we use for QMS ISO 13485:2016 - Medical Device Quality Management Systems 5
I QMS documents required at each stage of Software development IEC 62304 - Medical Device Software Life Cycle Processes 5
T QMS Training for my organization - IATF16949 and also AS9100 or 9145 Manufacturing and Related Processes 2
A How to manage the QMS system and SOP during the transition from MDD to MDR EU Medical Device Regulations 4
GreatNate QMS in SharePoint - Is anyone doing this? Manufacturing and Related Processes 7
F Quality Objectives - Where in the QMS Quality Objectives should be located ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Referencing the MDR by name in QMS SOPs EU Medical Device Regulations 2
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
Farley.0 QMS Sales Goals & Quality Objectives Manufacturing and Related Processes 22
Similar threads


















































Top Bottom