standard operating procedure -SOP ( a detail discussion )martinshaji
Standard Operating Procedures (SOPs) are an integral part of Good Manufacturing Practices. Without SOPs its really tough to run such big infrastructures of Pharma Manufacturing Units. SOPs are also required as regulatory requirements & every worker must be aware of the SOPs related to his/her job function.
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thank uu
It is real Art and Talent to make an effective Standard Operating procedure and understanding of the difference between guideline and SOP.
SOP should tell itself
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
standard operating procedure -SOP ( a detail discussion )martinshaji
Standard Operating Procedures (SOPs) are an integral part of Good Manufacturing Practices. Without SOPs its really tough to run such big infrastructures of Pharma Manufacturing Units. SOPs are also required as regulatory requirements & every worker must be aware of the SOPs related to his/her job function.
please comment
thank uu
It is real Art and Talent to make an effective Standard Operating procedure and understanding of the difference between guideline and SOP.
SOP should tell itself
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
This slide includes:
Standard Operating Procedures (SOP) - its definition, types, needs, method of SOP making, General Areas Covered by SOP in a Pharmaceutical Industry, Do's and Don't while making SOP definition and types of parenteral preparation in BRIEF.
The questions added at the end of the presentation is based on the asking pattern of CSVTU, Bhilai.
STANDARD OPERATING PROCEDURE FOR PUBLISHING COURTESY
ADVERTISEMENT, SPONSORSHIP& OTHER PUBLICITY INITIATIVES BY SECL MBA/BBA presentation Pune University/Mumbai University/kolkata university / Best PPT
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
standard operating procedure are the important document for pharmaceutical company & organization which may follow reference copy of the manufacturing batch or lot.
Thought At Work partners with you to examine your processes and help you with transform the processes to achieve desired "Shared Value" not only from the Customer but also from a Business point of view.
This slide includes:
Standard Operating Procedures (SOP) - its definition, types, needs, method of SOP making, General Areas Covered by SOP in a Pharmaceutical Industry, Do's and Don't while making SOP definition and types of parenteral preparation in BRIEF.
The questions added at the end of the presentation is based on the asking pattern of CSVTU, Bhilai.
STANDARD OPERATING PROCEDURE FOR PUBLISHING COURTESY
ADVERTISEMENT, SPONSORSHIP& OTHER PUBLICITY INITIATIVES BY SECL MBA/BBA presentation Pune University/Mumbai University/kolkata university / Best PPT
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
standard operating procedure are the important document for pharmaceutical company & organization which may follow reference copy of the manufacturing batch or lot.
Thought At Work partners with you to examine your processes and help you with transform the processes to achieve desired "Shared Value" not only from the Customer but also from a Business point of view.
ERP implementation helps with all business processes and areas which includes : CRM, Inventory, Sales, Accounting, Purchase, Manufacturing, HR, Project Management.
Process Management by Jan Mohammed.pptxJanMohammed3
This is a very generic presentation on Process Management concepts and its design + implementation. Use it to understand what process management entails and to coach your teams / customers.
When Management Asks You: “Do You Accept Agile as Your Lord and Savior?"admford
So you’ve been told that your organization is going to implement Agile methodologies across ALL of IT, and not just in development. And you’ve been given the responsibility to implement it in Security Operations, and without a clear plan or measurable objectives other than “make the team more efficient”. While one can complain that someone in the C-Suite heard of the book “Scrum: The Art of Doing Twice the Work in Half the Time”, you still have a job to do. So the basics of Project Management, Agile, Scrum & Kanban are covered and how one can shoehorn these concepts into working in an operations context. Oh, and there will also be some finagling of where DevOps stands regarding Agile and Operations.
Apty's software adoption platform makes any web-based application easier to use and provides actionable insights to improve efficiency and reduce support costs.
When Management Asks You: “Do You Accept Agile as Your Lord and Savior?” - Ci...admford
Updated version of my original Cyphercon talk. With more useful information regarding how to enact change and better visual representation of certain concepts. This talk was given at CircleCityCon 10 in 2023
The key benefits of implementing SIC:
* Increased OEE (by focusing on immediate and relevant losses within the shift)
* Increased effectiveness (by utilizing high-quality data at its source to drive decision making)
* High speed of improvement (localized focus increases the speed of improvements)
* Improved employee engagement (teams gain significant control over how the line is run)
Line Crew Optimisation is a process that reviews and optimises the established flow patterns, links process steps in order to minimise cycle times and travel distance, and eliminates crossover points in order to achieve a continuous flow process
Part of OFX Academy Course: Improving Line Performance
http://academy.optimumfx.com/course/improving-line-performance/
Improving Packaging Line Performance –Using the correct Data and Drill Down Analysis
Part of OFX Academy Course: Improving Line Performance
http://academy.optimumfx.com/course/improving-line-performance/
Improving Packaging Line Performance –Using the correct Data and Drill Down Analysis
Part of OFX Academy Course: Improving Line Performance
http://academy.optimumfx.com/course/improving-line-performance/
Improving Packaging Line Performance –Using the correct Data and Drill Down Analysis
A ‘Continuous Improvement culture’ is one where both leaders and front line workers constantly drive for improvement, which will be evident from the ‘work habits’
What gets measured, gets managed! What gets managed can be maintained and improved upon. Auditing ensures that the meetings operate at a consistent high standard.
What gets measured, gets managed! What gets managed can be maintained and improved upon. Auditing ensures that the meetings operate at a consistent high standard.
Oprah Winfrey: A Leader in Media, Philanthropy, and Empowerment | CIO Women M...CIOWomenMagazine
This person is none other than Oprah Winfrey, a highly influential figure whose impact extends beyond television. This article will delve into the remarkable life and lasting legacy of Oprah. Her story serves as a reminder of the importance of perseverance, compassion, and firm determination.
Senior Project and Engineering Leader Jim Smith.pdfJim Smith
I am a Project and Engineering Leader with extensive experience as a Business Operations Leader, Technical Project Manager, Engineering Manager and Operations Experience for Domestic and International companies such as Electrolux, Carrier, and Deutz. I have developed new products using Stage Gate development/MS Project/JIRA, for the pro-duction of Medical Equipment, Large Commercial Refrigeration Systems, Appliances, HVAC, and Diesel engines.
My experience includes:
Managed customized engineered refrigeration system projects with high voltage power panels from quote to ship, coordinating actions between electrical engineering, mechanical design and application engineering, purchasing, production, test, quality assurance and field installation. Managed projects $25k to $1M per project; 4-8 per month. (Hussmann refrigeration)
Successfully developed the $15-20M yearly corporate capital strategy for manufacturing, with the Executive Team and key stakeholders. Created project scope and specifications, business case, ROI, managed project plans with key personnel for nine consumer product manufacturing and distribution sites; to support the company’s strategic sales plan.
Over 15 years of experience managing and developing cost improvement projects with key Stakeholders, site Manufacturing Engineers, Mechanical Engineers, Maintenance, and facility support personnel to optimize pro-duction operations, safety, EHS, and new product development. (BioLab, Deutz, Caire)
Experience working as a Technical Manager developing new products with chemical engineers and packaging engineers to enhance and reduce the cost of retail products. I have led the activities of multiple engineering groups with diverse backgrounds.
Great experience managing the product development of products which utilize complex electrical controls, high voltage power panels, product testing, and commissioning.
Created project scope, business case, ROI for multiple capital projects to support electrotechnical assembly and CPG goods. Identified project cost, risk, success criteria, and performed equipment qualifications. (Carrier, Electrolux, Biolab, Price, Hussmann)
Created detailed projects plans using MS Project, Gant charts in excel, and updated new product development in Jira for stakeholders and project team members including critical path.
Great knowledge of ISO9001, NFPA, OSHA regulations.
User level knowledge of MRP/SAP, MS Project, Powerpoint, Visio, Mastercontrol, JIRA, Power BI and Tableau.
I appreciate your consideration, and look forward to discussing this role with you, and how I can lead your company’s growth and profitability. I can be contacted via LinkedIn via phone or E Mail.
Jim Smith
678-993-7195
jimsmith30024@gmail.com
The case study discusses the potential of drone delivery and the challenges that need to be addressed before it becomes widespread.
Key takeaways:
Drone delivery is in its early stages: Amazon's trial in the UK demonstrates the potential for faster deliveries, but it's still limited by regulations and technology.
Regulations are a major hurdle: Safety concerns around drone collisions with airplanes and people have led to restrictions on flight height and location.
Other challenges exist: Who will use drone delivery the most? Is it cost-effective compared to traditional delivery trucks?
Discussion questions:
Managerial challenges: Integrating drones requires planning for new infrastructure, training staff, and navigating regulations. There are also marketing and recruitment considerations specific to this technology.
External forces vary by country: Regulations, consumer acceptance, and infrastructure all differ between countries.
Demographics matter: Younger generations might be more receptive to drone delivery, while older populations might have concerns.
Stakeholders for Amazon: Customers, regulators, aviation authorities, and competitors are all stakeholders. Regulators likely hold the greatest influence as they determine the feasibility of drone delivery.
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Artificial intelligence (AI) offers new opportunities to radically reinvent the way we do business. This study explores how CEOs and top decision makers around the world are responding to the transformative potential of AI.
2. Intent of Session
• To understand Standard Operating Procedures
• To explain how these are put together
• To understand the opportunities to use them in
the work environment
3. What are they?
• When we buy something like a mobile phone, there are
usually two user documents:
– A manual – 20 pages or more of detailed text
– A ‘Quick Guide’ – normally one piece of paper with graphics
• We can consider the Standard Operating Procedure as
our ‘manual’, and the One Point Lesson as the ‘Quick
Guide’
• Standard Operating Procedure – detail on how the
each step of the task is performed, used as a reference
4. Why use SOPs?
• A successful business needs committed workers who
complete work procedures consistently and accurately
• It also requires all involved to contribute their experience,
knowledge, and ideas to constant improvement for the future
• Standard operating procedures get everyone driving toward
outstanding performance and success
• Well-written standard operating procedures provide direction,
improve communication, reduce training time, and improve
work consistency
5. SOP Use
A great example of where SOPs may
have helped:
• An airline crew and technical contractors,
taking delivery of a new passenger
aircraft, chose to test the engines near a
hangar
• As the aircraft neared take off power,
alarms sounded. A member of the crew
removed a ‘ground sense’ circuit breaker
to silence the alarms
• The aircraft’s computer, thinking it was in
the air, then automatically released the
brakes (a safety feature to prevent
landings with brakes on)
• The $200million aircraft hit a concrete
wall at full power and was written off
6. Where are SOPs relevant?
• The SOP development process is an excellent way for managers,
workers, and technical advisers to cooperate for everyone’s
benefit
• Standard operating procedures used in combination with planned
training and regular performance feedback lead to an effective
and motivated workforce
• Managers and teams benefit from consistent work performance
and predictable results
• They are required to comply with ISO standards
• They should be kept live and relevant to the what is actually
going on in the workplace – updated where necessary
7. Identifying Opportunities for SOPs
Some clues that a Standard Operating Procedure is needed:
• Team is unable to complete a task because the individual with the
knowledge is absent – why doesn’t everyone else know?
• Consistent delays or errors due to lack of what other team members
would consider basic knowledge – how can we make sure everyone
knows what to do?
• Frequent requests for the same set of information or training – do
we need something people can refer to?
• ‘Near misses’ – narrowly avoided potential failures with product
quality or safety – what is the best way to stop it happening for real?
8. About Standard Operating Procedures
• A written document or instruction detailing all the steps and
activities of a process or procedure
• All quality impacting processes and procedures should be
documented in Standard Operating Procedures (SOPs)
•
• SOPs should form the basis for the routine training program of
each employee
• SOPs should be regularly updated to ensure compliance to
the regulatory requirements and working practices
• Procedural changes or adjustments should be reflected by
updates to the SOP
9. Definition of a ‘Standard’
A standard is the “best, safest, and easiest way
to do a job or task which ensures consistent
quality, cost and delivery to the customer”
• How can we ensure we achieve this consistently?
• How can we identify and share best practice?
• How can we ensure training is carried out
thoroughly?
10. Systems, Procedures and Steps
Management systems are made up of procedures, which in
turn are made up of individual steps
System
Procedure Procedure Procedure Procedure
Steps Steps Steps Steps
11. Systems, Procedures and Steps
• Management systems are made up of work procedures. For
example, before production can begin, the line must be
correctly set up. After production, changeover and possibly
cleaning will need to take place. These are examples of
procedures that when put together make up the production
management system
• Finally, steps are the smaller actions that when put together
form a procedure. The small steps are where variation
among different workers takes place if procedures are not
standardised
• Managers can use standard operating procedures to help
ensure everyone performs each procedure the same way
every time
12. Formats for SOPs
• The goal is to create a document that is easy for the reader
to understand and helpful for the work at hand
• Two factors determine what type of SOP to use
– First, how many decisions will the user need to make during the procedure?
– Second, how many steps and sub-steps are in the procedure?
Many Decisions ? More than 10 steps? Recommended SOP Format
No No Simple Steps
No Yes Hierarchical or Graphic
Yes No Flowchart
Yes Yes Flowchart
13. SOP - Document Header
SOP Title Version
Reason for Revision Revision Date
Prepared by Reviewed by
Authorised by Document Owner
17. Developing and Implementing SOP’s
1. Plan for Results – start with business goal in mind
2. First Draft – select a format – there will be revisions – perfection
will come later
3. Internal Review – ask each team member to review and comment
and revise the procedure if necessary
4. External Review – do the same for your technical teams
5. Testing – have someone perform each step exactly as in the
procedure, while the writer watches – revise anything that causes
hesitation or confusion
6. Post – Make a final draft and post in workplaces and the central
master SOP file
7. Train – train, or re-train everyone involved to follow the procedure
18. Effective Writing of SOPs
• SOP instructions should be easily understood by anyone
using them.
• Which do we prefer?:
– “Make sure that you clean out all of the old caps from the cap hopper
before you refill with new materials”
– OR “Empty all old caps before adding new materials”
• Use abbreviations and acronyms sparingly. They may be
easily understood by engineers or technical staff, but do
the operators know them?
19. What If
• Without SOP’s we risk:
– Tasks being performed inconsistently
– Delays and errors through individuals not having the correct information
available
– Inconsistencies in training
– Heavy reliance on those with procedural knowledge
• With SOP’s we have:
– The opportunity to share best practice knowledge
– A proven method which everyone can follows
– Training documents readily available
– Knowledge available for everyone to use effectively