Professional Documents
Culture Documents
External QMSRisks and opportunities
External QMSRisks and opportunities
EXTERNAL ISSUES
Compliance to Legal
1 Legal Compliance
requirements
Not meeting Legal requirements 5 1 5 L
More Customers, to
Depending on Few customer , leads
Depending on Few Ensure that there is no
to Not fully utilizing production Explore the market, we need to do
3 Customers breakup in production/
capacity
4 3 12 m
marketing after obtaining the Certifications
Full capacity production
should run
Non availability of raw Material availability for Delay in starting the production Keeping stock of material, /or developing
4 material in the market batch of production batch
3 3 9 M
usage method of alternate raw material
PREPARED BY APPROVED BY
Risk Score between 1 to 7 considered as low and Acceptable: between 8- to 15 Medium , we need to make action plan, Rating 16-25 high Risk
CONTEXT OF THE ORGANISATION
EXTERNAL ISSUES
New formulation of
Abel to manufacture with new Loss of business due to new Develop new technologies, new
10 drugs/New
formulations drugs/technologies in the market
3 3 9 M
drugs with new formulations
technologies
Transport
delay/damages in
On time delivery without Damages to product leads to
11 transport during
damages customer dissatisfaction
4 2 8 M Transporters rating to be done
product despatch to
customer end
Interaction with
Employees of SPARKVEE Training to be provided to sales
different levels of Communication gap between
should interact appropriately to staff on interpersonal skills,
13 customers/ different
different positions of customer
customers and SPARKVEE 2 3 6 L Communication and convincing
positions of customer employees
representatives skills
representatives
PREPARED BY APPROVED BY
Risk Score between 1 to 7 considered as low and Acceptable: between 8- to 15 Medium , we need to make action plan, Rating 16-25 high Risk
CONTEXT OF THE ORGANISATION
EXTERNAL ISSUES
1 Minimal Little impact on Quality and Business, Interested parties not affected
May affects Quality performance and business performance of the organisation the organisation. Minor affect
3 Moderate
on interested parties
4 Major Likely to affect Business performance of the organisation, Effect on interested parties,
5 Severe Likely to affect Business performance, Dissatisfaction of interested parties. Not meeting Compliance obligation