Cup of Joe

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Before making any big decision, it’s always recommendable to think it through. It’s not an easy task to find a good outsourced manufacturer for your needs, for your medical device that should conquer the market. The Real World, Choose Me, Things To Think About, Medical, Big, Easy, How To Make, Medicine, Active Ingredient
The Real WorldChoose MeMedicalEasyHow To Make

Cup of Joe #45 - How to choose a good manufacturer?

Before making any big decision, it’s always recommendable to think it through. It’s not an easy task to find a good outsourced manufacturer for your needs, for your medical device that should conquer the market. #qms #manufacturer #cupofjoe #qualitymanagement #choose #production #product #outsourced

When someone owns a medical device company, but not having a space or supplies for producing equipment, then they hire a contractor, outsourced manufacturer. What Have You Done, Life Cycles, When Someone, No Response, Medical, Space, Floor Space, Medicine

Cup of Joe 44# - Whose monitoring responsibility is when you have outsourced production?

When someone owns a medical device company, but not having a space or supplies for producing equipment, then they hire a contractor, outsourced manufacturer. #qms #manufacturer #cupofjoe #outsorced #owner #responsibility #production

Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means?Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means? 5 Whys, Us Data, People Working Together, My Magazine, Keep Trying, Risk Management, Health Goals, Startups, Problem Solving

Cup of Joe #43 - Treat the cause, not the symptom

Root Cause Analysis is something that we all do when we want to solve a problem for good. But what RCA actually means? #RootCauseAnalysis #qms #riskmodule #riskmanagement #rca #qualitymanagement #software #problemsolving #medicaldevice #medtech #smallbusiness #startups #b2b #comic #illustration #situation #learning #teaching #solve #problem #magazine #fish #table

To manage the suitable CAPA activity, it is important to track, manage and evaluate all different quality data points within the organization, and to manage key performance indicators throughout the process. Bad Reviews, Good Manufacturing Practice, Track, Things To Come, Organization, Key, Activities, Getting Organized, Organisation
Good Manufacturing PracticeActivitiesOrganisation

Cup of Joe 42# - Dealing with CAPA

To manage the suitable CAPA activity, it is important to track, manage and evaluate all different quality data points within the organization, and to manage key performance indicators throughout the process. #capa #corrective #preventive #risk #qms #audit #fda #qualitymanagement #medicaldevice #medtech

When implementing and maintain ISO standard such as ISO it is burdensome to maintain paper-based documentation and it’s very time-consuming. It is quite a struggle to find information when needed in the thick of ‘forest’ of document history. Iso 13485, How To Run Longer, How To Become, Software, Base, History, Historia
Iso 13485How To BecomeHistoria

Cup of Joe 41# - 4 reasons - why eQMS over paper-based QMS

When implementing and maintain ISO standard such as ISO 13485, it is burdensome to maintain paper-based documentation and it’s very time-consuming. It is quite a struggle to find information when needed in the thick of ‘forest’ of document history. #iso13485 #qms #eQMS #qualitymanagement #paper-based #toplist #software #CupOfJoe

Cup of Joe - Documents and procedures amendment Document Management System, Company Check, Decision Making, Work On Yourself, April 13, Apps, Change, Making Decisions, App

Cup of Joe 40# - Documents and procedures amendment

Changes to documents shall be reviewed and approved. Approved changes must be communicated to the affected personnel. Also, the company should maintain records of changes to documents and it should include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective. #qms #fda #regulation #cupofjoe #dms #documentmanagement #audit

A successful audit relies on communication. So, preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps. Can You Show Me, Can You Help, Meet The Team, Everyone Knows, Factors, No Worries, Communication, Success, Activities
Can You Show MeActivities

Cup of Joe 39# - Key factor during an audit–prepared employees

A successful audit relies on communication. So, the preparation of employees in order to know exactly how to interact with the auditors when they arrive is one of the most important steps. Read more on our blog. #audit #preparation #prepare #employees #qms #eQMS

Cup of Joe - There is such a thing like painless audit? Investigations, How To Memorize Things, Let It Be, Activities, Blog

Cup of Joe 38# - There is such a thing like painless audit?

An audit is verification of activities – process or quality system in order to ensure compliance to some requirements. Read more on our blog. #audit #cupofjoe #eQMS #qms #regulation #inspection

Cup of Joe - Why we have to perform an audit? Internal Audit, Risk Management, Bullying, Told You So, Positivity, Shit Happens, Words, Blog, Bullies
Internal AuditTold You SoWords

Cup of Joe 37# - Why we have to perform an audit?

At work, nothing raises the hairs on the back of your neck like the word “audit”. Read more on our blog! #cupofjoe #audit #regulation #inspection #qms

An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step. Scary Words, Process Improvement, How To Apply, Organization, Activities, Getting Organized, Organisation, Tejidos
ActivitiesOrganisationTejidos

Cup of Joe 36# - Scary word “Audit”

An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step. #audit #cupofjoe #qms #inspection #regulation

One of the main criteria for an eQMS is to have implemented an electronic signature. read more on our website E Signature, Electronics, Website, Signs, Shop Signs, Sign, Consumer Electronics

Cup of Joe 35# - Signing your electronic documents

One of the main criteria for an eQMS is to have implemented an electronic signature... read more on our website #signing #sign #electronic #documents #qms #eQMS #audit

Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS. E Signature, Folder Organization, Software, Medical, Handle, Electronics, Tips
E SignatureMedicalElectronicsTips

Cup of Joe 34# - How to organize your folders?

Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS.

One of the main fears when transferring from paper-based to eQMS is how to handle a lot of file versions, how should we name them, should we import every single version? How To Make Notes, Handle, History, Paper, Historia, How To Take Notes
Historia

Revision History helps you with transferring to eQMS

One of the main fears when transferring from paper-based to eQMS is how to handle a lot of file versions, how should we name them, should we import every single version? #eQMS #revisionhistory #QMS #paper-based #namingfiles #transition

Pickled mice lead to pickled companies. There are no savings when avoiding preventive actions. Mice, Geek Stuff, Action, Geek Things, Group Action, Computer Mouse
Geek Things

Weekly Cup of Joe #23– Corrective and Preventive Action (CAPA)

Ignoring preventive actions might sound like saving money at first, but not investing resources into improving processes will cost more on a long term.

If your company would like to achieve ISO 9001 certification, provide a clear picture of the organization's context to the auditors! Calm Down, Everything, Meant To Be

Weekly Cup of Joe #20 – Everything is Not What It Seems

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project… your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance. ISO Audit and the Company Image The Company must have...

Inappropriate or late requirements can result in the project being in the wrong place at wrong time! Wrong Time, Places, Projects, Log Projects, Blue Prints, Lugares
Log ProjectsBlue Prints

Weekly Cup of Joe #19 –Projects in Wrong Place and Time

Few tips on Project requirements are one of the first things that have to be determined when starting a new project.