An audit is a systematic, independent examination to determine if quality activities and results comply with planned arrangements and if those arrangements are effectively implemented and suitable to achieve objectives. Audits are performed to collect objective evidence that allows for an informed judgment about the system or product being audited. There are internal audits performed by a company's own employees and external audits performed by outside parties like customers or independent organizations. The goal of audits is to determine compliance and ensure quality.
Deals in detail about total quality management (TQM) in all aspects of industries to be followed for optimum quality production and human resource management.
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
Deals in detail about total quality management (TQM) in all aspects of industries to be followed for optimum quality production and human resource management.
Quality audit is defined as a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives Quality audit means a systematic examination of a quality system
Quality audits are typically performed at defined intervals
.Definition
Objectives
Difference between Quality audit and Periodic evaluation
Self inspection
Types of Quality Audit
Role OF GMP Audit in QA and QC programmes
Elements of a Systemic Audit program
Dr. V. S. Kashikar
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
A quality audit, also known as a quality assurance audit or compliance audit, is a systematic examination and evaluation of processes, systems, and records to determine compliance with established quality standards, regulations, guidelines, and best practices. The purpose of a quality audit is to identify areas of non-compliance, assess the effectiveness of quality management systems, and identify opportunities for improvement. Here are some key aspects of a quality audit
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Quality Assurance is of Tremendous Importance in Pharma and Health care sector.
A brief of that is try to explain here..
A Trust of the Customer on Product is solely based on the Effective QA
A quality management system is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
A quality audit, also known as a quality assurance audit or compliance audit, is a systematic examination and evaluation of processes, systems, and records to determine compliance with established quality standards, regulations, guidelines, and best practices. The purpose of a quality audit is to identify areas of non-compliance, assess the effectiveness of quality management systems, and identify opportunities for improvement. Here are some key aspects of a quality audit
According to new syllabus of PCI M.Pharm 1st sem. students can directly utilize this ppt for their study. As per PCI new syllabus QA STUDENTS find this ppt very use full.
Targeted drug delivery to the respiratory system- An article Satyaki Mishra
This is an article (preview) on Pulmonary drug delivery system written for partial submission of Post-graduation assignment.. The study further helps in enhancing knowledge on target specific drug delivery system. If this article is of any help to you, kindly consider downloading it. You can drop your mail id in the comment section.
The presentation gives a brief explanation about the 8 pillar of TPM.It is medical science of machines.TPM focuses on maintenance as a necessary and vitally important part of the business. It is no longer regarded as a non-profit activity. The goal is to hold emergency and unscheduled maintenance to a minimum.
12 Most Profound Quotes from Facebooks CEO Mark ZuckerbergEkaterina Walter
12 quotes by Facebook's CEO Mark Zuckerberg from the book "Think Like Zuck: The Five Business Secrets of Facebook's Improbably Brilliant CEO Mark Zuckerberg” by Ekaterina Walter (http://bit.ly/think-like-zuck)
This presentation was created about a month ago in light of his resignation. However, recently, Steve Jobs has passed away and these quotes become evermore real of his brilliance and courage to change the world. Remember his legacy and the impact he left on all of us.
Rest in peace Steve Jobs. 1955-2011
Second Party Audit and External Third Party AuditShantanuThakre3
Second Party Audit:- Second-party audit is when a company performs an audit of a supplier to ensure that they are meeting the requirements specified in the contract.
External Third Party Audit:-
A third-party audit occurs when a company has decided that they want to create a Quality Management System (QMS) that conforms to a standard set of requirements, such as ISO 9001 and hire an independent auditing company to perform an audit to verify that the company has succeeded in meeting these standards.
The three-day course, "Introduction to CMMI", introduces participants to the fundamental concepts of the CMMI model. The course assists companies in integrating best practices from proven discipline-specific process improvement models, including systems engineering, software engineering, integrated product and process development and supplier sourcing.
The course is composed of lectures and class exercises with ample opportunity for participant questions and discussions. After attending the course, participants will be able to describe the components of CMMI, discuss the process areas in CMMI, and locate relevant information in the model.
The workshop will help the participants to:
Understand the CMMI framework
Understand the detailed requirements of the process areas in the CMMI V1.3
Make valid judgments regarding the organization's implementation of process areas
Identify issues that should be addressed in performing process improvements using the CMMI V1.3
Define, select, and apply various techniques including supplier qualification, certification, evaluation, ratings, performance
improvement, and so on.
The #DROOS_FLGAWDA channel is dedicated to providing scientific content that effectively contributes to building knowledge among interested and quality workers as well as manufacturers and service providers so that they can achieve their products better, faster and at the lowest cost.
Simply channel #DROOS_FLGAWDA... will change your life for the better
JOIN-US FOR FREE
https://goo.gl/4S8PQ8
These slide is about very famous topic of Software Testing
> Acquisition
> Acquisition Process
> Step 1: Plan the Acquisition
> Step 2: Define the Software Product
> Step 3: Determine acquisition approach
> Step 4: Identify and Evaluate Potential Suppliers
> Step 5: Define Contract Requirements
The Art Pastor's Guide to Sabbath | Steve ThomasonSteve Thomason
What is the purpose of the Sabbath Law in the Torah. It is interesting to compare how the context of the law shifts from Exodus to Deuteronomy. Who gets to rest, and why?
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Students, digital devices and success - Andreas Schleicher - 27 May 2024..pptxEduSkills OECD
Andreas Schleicher presents at the OECD webinar ‘Digital devices in schools: detrimental distraction or secret to success?’ on 27 May 2024. The presentation was based on findings from PISA 2022 results and the webinar helped launch the PISA in Focus ‘Managing screen time: How to protect and equip students against distraction’ https://www.oecd-ilibrary.org/education/managing-screen-time_7c225af4-en and the OECD Education Policy Perspective ‘Students, digital devices and success’ can be found here - https://oe.cd/il/5yV
We all have good and bad thoughts from time to time and situation to situation. We are bombarded daily with spiraling thoughts(both negative and positive) creating all-consuming feel , making us difficult to manage with associated suffering. Good thoughts are like our Mob Signal (Positive thought) amidst noise(negative thought) in the atmosphere. Negative thoughts like noise outweigh positive thoughts. These thoughts often create unwanted confusion, trouble, stress and frustration in our mind as well as chaos in our physical world. Negative thoughts are also known as “distorted thinking”.
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
2. A systematic and independent examination to
determine whether quality activities and related
results comply with planned arrangements, and
whether these arrangements are implemented
effectively and are suitable to achieve objectives
2
3. To collect objective evidence to permit an informed
judgment about the status of the systems or product
being audited
3
4. Internal (First Party, Self)
This type includes audits by company employees,
consultants and contractors
5
5. External
i. Supplier Audit
○ Second Party
Customer employee(s) audit your company
or
Your employee(s) audit a company which
supplies your company with a product or
service
6
6. ii. Independent Organization
Third Party Audit
○ A customer wants an audit of your company
7
7. 1. Compliance (do we comply with the standard)
Example: Desk audit of high level systems
2. System (the theory)
Example: Audit of Document Control
3. Process (the practice)
Example: Audit of any process (manufacturing)
4. Product (the result)
Example: Audit of finished products to fulfil
technical specifications
8
8. 1. Auditor: A person who has appropriate qualifications
and performs audits.
2. Client: A person or organization requesting the audit.
For internal audits, this is the Management
Representative.
3. Auditee: An organization, facility or person being
audited.
9
9. 4. Quality System: The organizational structure,
responsibilities, procedures, processes and
resources for implementing quality management.
5. Observation: A statement of fact made during an
audit and substantiated by objective evidence.
6. Nonconformity: The non-fulfillment of specified
requirements.
10
10. 7. Objective Evidence: Qualitative or quantitative
information, records or statements of fact pertaining
to the quality of an item or service or to the
existence and implementation of a quality system
element, which is based on observation,
measurement or test and which can be verified.
11
11. (A) Imposed upon
manufacturer or
supplier
Third party (on
Customer, or
Regulatory behalf of
potential customer
customer)
12
12. (B) Performed by
manufacturer
(i) Internal (self-
(ii) External
inspection)
13
14. • Determine the level of compliance
• Build confidence (hopefully) in GMP and the QA system
• Build interdepartmental trust, understanding, and communication
(if the audit is done properly and tactfully)
• Determine measures necessary to improve, e.g.,:
• Premises, equipment, environment
• Operations, actions, procedures
• Personnel/training
• Provide a stimulus for improvement
• Recommend corrective action
• Monitor improvement
15
15. • Establish and monitor capability of supplier or
contractor to deliver
• goods and services that are fit for purpose (and on
time, and in the quantity required)
• Build mutual confidence
• Promote understanding and communication
between the parties involved (both sides can learn!)
• And in general, as listed for “internal”
16
16. Plan and
prepare
Arrange and
Follow-up
announce
Arrive at site of
Formal report, with
audit, meet, explain
recommendations
purpose
Informal oral
Perform
report of
audit
finding
17
18. examination of
1. established methods
2. instructions
3. work flow for processes
4. maintenance programs for production equipment
5. material handling
6. housekeeping around the work area
19
19. Here company’s procedures are validated
Processes are sub-parts of a system.
Process audits are generally a part of larger system(s)
audit.
However , they can be performed independently
○ An internal audit may indicate need to perform a specific
process audit
Almost always, one or more other process(es) will interact
with any given process.
One very important issue to consider is the effectiveness of
communications between systems and/or processes.
20
21. 1. Documents
a. Quality and GMP regulations, standards, and guidelines
(local, national, and international)
b. Previous audit and follow-up reports
c. Auditee’s own documents and records
d. Audit checklists
requires that auditor evaluates a certain number of
procedures, plans and documents
2. The auditors own eyes, ears, brain, words, character, etc.
3. The auditing plan
22
22. 1. Is there a documented sanitation program?
2. Are the specifics of the program followed?
3. Are there standard operating procedures (SSOPs)?
4. Is a pre-operational audit conducted prior to production?
5. Are corrective actions taken in response to pre-op
findings?
6. What are the general conditions in the plant?
7. Are the floors, walls and ceilings in good condition?
8. Are the exterior structure and grounds maintained in a
condition to prevent contamination?
23