The document provides information about internal process audits. It discusses management systems, standards, effectiveness and efficiency, quality management system principles and elements. It defines an audit and describes the purpose, benefits, types, preparation, performance, non-conformity reports, post-audit activities and best practices of audits. The document emphasizes that audits are meant to determine conformity and provide opportunities for improvement, not to evaluate people's capabilities. It also provides tips on how to effectively face an audit.
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
How to Perform a Successful Internal Quality AuditGreenlight Guru
You already know internal quality audits are required by both FDA 21 CFR Part 820 and ISO 13485.
You also probably already know they are a big hassle to conduct.
What you might not know is that they are one of the most powerful weapons at your disposal for preventing 483's and observations.
Why?
Because they are one of the most effective and efficient ways to make sure you and your team are always prepared if FDA or NB decided to show up unexpectedly.
So how do you “establish” the right procedures? How do you ensure your auditor is competent and properly qualified? And what do you do if you find non-conformances?
View this presentation by our guest Kyle Rose, President at Rook Quality Systems, where you will find the answers to all those questions and more.
Specifically, you will learn:
- How to conduct an effective internal quality audit based on process identification, sampling and questioning
- How to plan a internal quality audit and develop an audit schedule
- How to find and use competent and qualified auditors
- Why certain auditors shouldn’t audit certain areas
- How to properly report the findings of your internal quality audit
- How to concisely document non-conformances
- How to determine what needs corrective actions and how to follow up on them
Internal Audit is a tool of control to measure and evaluate the effectiveness of the working of an organization primarily with accounting, financial and operational matters.
Internal Audit plays a constructive role by rendering service to the management with objective appraisal of systems, procedures, practices, compliance with policies.
LetzConsult presents a smarter ways for companies to find the most relevant Consultant for their business needs. Find the right consultants for your Company on LetzConsult.com
What is the purpose of internal auditing? How important is it to the business? How are internal audits planned and carried out? These slides show the relevance of internal audit to the business, how internal audits relate to the objectives and risks of the business, how they are planned and the work involved in an internal audit. Further advice is available from www.internalaudit.biz
Internal Audit Training.
Training Objectives.
What is an audit?
How to prepare for and plan an audit?
How to conduct an audit?
How to report on an audit?
What is audit follow-ups?
Contact:
nomanaleemft@gmail.com
00923084089243
The most comprehensive definition of internal audit is given by the IIA, USA. It is,
"Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization’s operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes."
The purpose of the presentation is to provide clarification for a better understanding of what internal audit definition, objectives, functions, stages and reporting are all about? What difference does it make in the presence of an external audit? How different is its scope from that of the external audit? How internal audit standards contribute to better performance of internal audit work and its reporting to the Board or Audit Committee?
Firstly, it will be clarify some of the misunderstandings of some of the fundamental audit concepts and principals that are implemented during the audit or planning of the audit program, focusing on audit guidelines, auditor principles, audit process principles and types of audits. Furthermore, gaining understanding of the management and preparation of an ISO 9001 audit through audit program pillars, good audit practices and prepared work documents and checklists. Outline how to conduct and close an ISO 9001 audit in a professional manner with the precise audit review.
Main points covered:
• Fundamental audit concepts and principles
• Managing an ISO 9001 audit program
• Preparation of an ISO 9001 audit
• Conduct of an ISO 9001 audit & Closing the audit
Presenter:
This webinar was presented by Kefah El-Ghobbas, PECB Certified Trainer and Organizational Development expert and operations manager at TURBO CARBO.
Link of the recorded session published on YouTube:https://youtu.be/kK8pAc3QM5E
Internal Audit is a tool of control to measure and evaluate the effectiveness of the working of an organization primarily with accounting, financial and operational matters.
Internal Audit plays a constructive role by rendering service to the management with objective appraisal of systems, procedures, practices, compliance with policies.
LetzConsult presents a smarter ways for companies to find the most relevant Consultant for their business needs. Find the right consultants for your Company on LetzConsult.com
What is the purpose of internal auditing? How important is it to the business? How are internal audits planned and carried out? These slides show the relevance of internal audit to the business, how internal audits relate to the objectives and risks of the business, how they are planned and the work involved in an internal audit. Further advice is available from www.internalaudit.biz
Internal Audit Training.
Training Objectives.
What is an audit?
How to prepare for and plan an audit?
How to conduct an audit?
How to report on an audit?
What is audit follow-ups?
Contact:
nomanaleemft@gmail.com
00923084089243
The most comprehensive definition of internal audit is given by the IIA, USA. It is,
"Internal auditing is an independent, objective assurance and consulting activity designed to add value and improve an organization’s operations. It helps an organization accomplish its objectives by bringing a systematic, disciplined approach to evaluate and improve the effectiveness of risk management, control and governance processes."
The purpose of the presentation is to provide clarification for a better understanding of what internal audit definition, objectives, functions, stages and reporting are all about? What difference does it make in the presence of an external audit? How different is its scope from that of the external audit? How internal audit standards contribute to better performance of internal audit work and its reporting to the Board or Audit Committee?
Firstly, it will be clarify some of the misunderstandings of some of the fundamental audit concepts and principals that are implemented during the audit or planning of the audit program, focusing on audit guidelines, auditor principles, audit process principles and types of audits. Furthermore, gaining understanding of the management and preparation of an ISO 9001 audit through audit program pillars, good audit practices and prepared work documents and checklists. Outline how to conduct and close an ISO 9001 audit in a professional manner with the precise audit review.
Main points covered:
• Fundamental audit concepts and principles
• Managing an ISO 9001 audit program
• Preparation of an ISO 9001 audit
• Conduct of an ISO 9001 audit & Closing the audit
Presenter:
This webinar was presented by Kefah El-Ghobbas, PECB Certified Trainer and Organizational Development expert and operations manager at TURBO CARBO.
Link of the recorded session published on YouTube:https://youtu.be/kK8pAc3QM5E
A presentation given by Gary Mainwaring to the APM Planning, Monitoring and Control SIG and guests at the University of Warwick, Coventry 2015.
Gary Mainwaring General Dynamics – Benefits Management is a Marathon not a sprint. The critical success factors are: Adapt, Support, Evolution, Elevate, Champion and Culture.
Top 20 c# interview Question and answersw3asp dotnet
This presentation contains interview question and answers . www.w3asp.net provide you the information, knowledge, job, practices and tranings regarding asp.net.
Customer Relationship Management (CRM) software solutions and their impact on business growth and profitability continue to increase in importance for Logistics and Transportation leadership teams. Sales Outcomes has compiled their top 6 critical considerations for a CRM investment in the Logistics and Transportation industry.
Internal audit means a continuous critical review of financial and operating matters of a business. In other words, we can say that the audit of a business conducted by the business for a continuous basis. Internal audit is done by the internal staff appointed particularly for the audit purposes. These are called internal auditors.
This presentation was conducted by Peter Glynne to the Yorkshire & North Linconshire APM membership providing a practical insight into the realisation of benefits
Sarbanes-Oxley was passed in the wake of a number of notable corporate accounting scandals including Enron and WorldCom.
And now in this training presentation, you will understand why and how this is important for us.
Presented for ASQ India on 3/22/2016 7PM - 8PM IST (6.30 AM -7.30AM PST). Govind will briefly discuss key changes, new requirements and a high level transition plan. The new standard is more aligned with business than ever. However this new standard also bring challenges for auditing. As a QMS manager, auditor or even a practitioner you will be expected to apply this management system standard at work.
Many organizations can benefit from developing ISO 9001 Quality Management Systems (QMS) to improve the effectiveness and efficiency of their business operations.
ISO 9001 Quality Management Systems: Implementation and Integration features the author’s patented Three Step Process – “Identify, Insure, Improve,” in use since 1995 and developed, tested, and applied in actual business situations. It also explains how to integrate ISO 9000, ISO 14000 and OHSAS 18000 programs. This guide is a valuable resource for companies wanting to update their QMS or become certified for the first time.
ISO 9001 Quality Management Systems: Implementation and Integration is used by Quality Assurance/Quality Control Managers, EHS Managers, Risk Managers, Consultants, Loss Control and Operations Managers within manufacturing and service organizations.
Internal Audit Best Practices for Safety, Environment, and Quality AuditsNimonik
Nimonik has seen a wide variety of internal Health, Safety, Environmental and Quality (HSEQ) audit programs. They seem to come in all shapes and sizes! Each company tends to focus on different risks and controls.
Whether your organization conforms to ISO 19011 or another internal audit standard, re-focusing your internal audit program on your risks, controls, and operational reality is a key driver for operational excellence.
On March 14th, John Wolfe shared insights from over 20 years as a hands-on HSE Director and as the Sr. Director of Operations Integrity Audit for a global Oil & Gas company. John outlined the attributes of an outstanding Internal audit program. He showed you how you can build out a program tailored to your operations and add tremendous value to your business.
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.
What is quality? quality is a The ongoing process of building and sustaining relationships by assessing, anticipating, and fulfilling stated and implied needs.
Performance Management: A New National Standard with International ApplicabilityThe HR Observer
All organisations strive to reach their business objectives and look to their workforce for consistent and high performance. Managing employee performance and achieving results can be greatly enhanced when a goal setting process is used. This new National Standard published by the American National Standards Institute (ANSI) and the Society for Human Resource Management (SHRM) discusses how a focus on individual goal setting can help organizations with achieving organisational goals. This session will focus on how to build and develop an effective performance management system for any size or type of organisation.
John Dooney, Manager - Workforce Analytics and Research, SHRM
Attitude-Basics-Change are three most important aspect for adding value in whatever we are doing. Knowledge, Communication and Documentation are on one side and People, Project and Execution are on other side. It is about embedding a different sense in DNA of working.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
The world of search engine optimization (SEO) is buzzing with discussions after Google confirmed that around 2,500 leaked internal documents related to its Search feature are indeed authentic. The revelation has sparked significant concerns within the SEO community. The leaked documents were initially reported by SEO experts Rand Fishkin and Mike King, igniting widespread analysis and discourse. For More Info:- https://news.arihantwebtech.com/search-disrupted-googles-leaked-documents-rock-the-seo-world/
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
Putting the SPARK into Virtual Training.pptxCynthia Clay
This 60-minute webinar, sponsored by Adobe, was delivered for the Training Mag Network. It explored the five elements of SPARK: Storytelling, Purpose, Action, Relationships, and Kudos. Knowing how to tell a well-structured story is key to building long-term memory. Stating a clear purpose that doesn't take away from the discovery learning process is critical. Ensuring that people move from theory to practical application is imperative. Creating strong social learning is the key to commitment and engagement. Validating and affirming participants' comments is the way to create a positive learning environment.
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Kseniya Leshchenko: Shared development support service model as the way to ma...Lviv Startup Club
Kseniya Leshchenko: Shared development support service model as the way to make small projects with small budgets profitable for the company (UA)
Kyiv PMDay 2024 Summer
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Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
Editable Toolkit to help you reuse our content: 700 Powerpoint slides | 35 Excel sheets | 84 minutes of Video training
This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
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RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
Retail media wordt gezien als het nieuwe advertising-medium en ook mediabureaus richten massaal retail media-afdelingen op. Merken die niet in de betreffende winkel liggen staan ook nog niet in de rij om op de retail media netwerken te adverteren. Marvin belicht de uitdagingen die er zijn om echt aansluiting te vinden op die markt van non-endemic advertising.
2. Internal Process Audit
What is Management System?
“Set of interrelated or interacting elements to establish
policy and objectives and to achieve those objectives”
H/W
S/W
Humanware
MS
IT Solution
Infrastructure
System
3. Internal Process Audit
What is Standard ?
A Written document detailing minimum features,
specifications and requirement of product.
These are required to
(a) Prescribe the minimum requirements for Quality
(b) Ensure safety of operations both for workmen and users
(c ) Promote interchangeability of the product.
(d) Achieve variation reduction
4. Internal Process Audit
Effectiveness
“producing or capable of producing desired effect”
“extent to which planned activities are realized and planned
results are achieved”
Efficiency
“Acting or Producing effectively with a minimum of waste,
expense, or unnecessary effort”
“Exhibiting high ratio of output to input”
“relationship between the result achieved and the resources
used”
Effectiveness and Efficiency
5. Internal Process Audit
•Creating Customer Value
•Understanding Core Competence
(profound knowledge of business)
•Involvement of People
•Total optimization of system
•Process Approach
•Factual Approach
•Organization and Personal Learning
(Knowledge)
•Agility (To react Change)
Management System Principles
•Focus on Social Value
•Visionary Leadership
•Involvement of People
•Collaboration with partners
•Autonomy (Empowerment)
6. Internal Process Audit
Management Commitment Planning of Product Realization
Customer Focus Identify Customer Requirements
Quality Policy Review Product Requirements
Quality Objective Customer Communication
Quality Planning Design/Development Planning
Responsibility & Authority Purchasing
Management Representative Product/Service Realization operations
Internal Communication Customer Satisfaction/Dissatisfaction
Quality Manual Internal Quality Audit
Documents & Records Control Measure Process Conformance
Management review Measure Product Conformance
Providing Resources Control of Non-Conformity
Assigning Skilled Personnel Analysis of Data
Facilities Plan for continual Improvement
Work Environment Corrective and Preventive Action
Elements of QMS
7. Internal Process Audit
PLAN: ESTABLISH THE OBJECTIVES AND PROCESSES
NECESSARY T O DELIVER RESULTS IN ACCORDANCE
WITH CUSTOMER REQUIREMENTS AND
THEORGANIZATION’S POLICIES.
DO: IMPLEMENTS THE PROCESSES.
CHECK: MONITOR AND MEASURE PROCESSES AND
PRODUCAT AGAINST POLICIES,
OBJECTIVES AND REQUIREMENTS FOR THE PRODUCT
AND REPORT THE RESULTS.
ACT: TAKE ACTIONS TO CONTINUALLY IMPROVE PROCESS
PERFORMANCE.
Plan-Do-Check-Act (PDCA) Methodology
8. Internal Process Audit
Quality and Information Security
PDCA
Interested
Parties
Q/S
requirem
ents &
expectati
ons
Establish
MS
Monitor and
review MS
Maintain &
Improve MSImplement &
Operate MS
Development,
Maint. and
Improvement
Cycle
Plan
Do
Check
Act
Interested
Parties
Managed
Q/S
9. Internal Process Audit
Management System
Policy & Objective. Organisation Structure.
Responsibility and Authority Matrix. Management Review.
Reference to Procedures
Level 2 – Procedure /
Department Manual (Tactical)
Refers to number of activities of each department. Inerface
between departments (What to Do)
Level 3 – Work Instruction
(Operational)
Detailed step by step activities taken up for each operation
(How to do)
Records are proof of activities carried out. It is used to
analyze how good they are performed.
Format helps to record the data in systematic and
comprehensive manner.
Level 4 – Record , Formats
and Reports
Level 1 - Apex Manual
(Startegic)
10. Internal Process Audit
AUDIT-Definition
“systematic, independent and documented
process of obtaining audit evidence and
evaluating it objectively to determine the extent
to which audit criteria are fulfilled”
ISO 9000:2000
11. Internal Process Audit
AUDIT-Purpose
• To determine the conformity
• to determine activity/results are as per plan
• To determine the effectiveness
• To provide opportunity to improve
• To meet statutory regulatory requirements
• For certification
12. Internal Process Audit
AUDIT-Benefit
• Give Confidence to Management
• Give Confidence to Customer
• Observe Operational Problems
• Provide opportunity for Improvement
• Provide feedback for CA/PA (Corrective Action /Preventive Action)
13. Internal Process Audit
AUDIT-Who and Frequency
Audit is done to find conformance to what you write and
what you are doing is same or not.
How Often
: 2 Times a year
: can be separate for
different departments
Who Should Do IA
: Person can’t audit his
own department
: Needs IA Training
SUGGESTED FORMAT
14. Internal Process Audit
AUDIT-Types
First Party Audit Internal Quality Audit done by staff
members of company.
Second Party
Audit
Company audits its supplier
Third Party Audit Certifying body conducts audit
Initial Audit By Certifying Body which leads to ISO
certification
Surveillance Audit By certifying body every six month
after certificate is issued.
15. Internal Process Audit
• ISO 9000 Standards
• Quality Manual
• Department Manual /
Procedure
• Earlier Audit notes/
Checklists
• NCRs of last Audits
• MRM Minutes
Outcome : Questions /
Points of the Audit
i.e Audit Checklist
AUDIT-Preparation
SUGGESTED FORMAT
16. Internal Process Audit
• Gathering the information
• Document Review
• Sample Records
• Observations
• Interview
• Opening Meeting and Closing Meeting
• Link to Apex/ Dept Apex, Operational Manual
• Auditor’s word is final in case of observed facts
• Write full details of observations
• Write Suggestion to Improve the system more effective &
Efficient (Value Addition)
AUDIT-Perform
17. Internal Process Audit
Major/Minor NC (Non Conformity)
• Left out part of ISO 9000 requirements
• Non Compliance with Legal/Statutory requirements
• Safety Violation
• Intention to Deceive customer
• Discuss each NCR (Non Conformity Report)
• Use only one Clause which is best fitted
• Each NCR should have only one non conformity
AUDIT-NCR (Non Conformity Report)
18. Internal Process Audit
• Audit Report with observations (use Standard Format)
• Write NCRs (use Standard Format)
• Give it to Respective Dept Head and MR (management
Representative)
• Closing of NCRs after verification of the reply/action.
AUDIT-Post Audit Activities
19. Internal Process Audit
Time Allocation
(1) Preparation 35% to 40%
(2) Conducting 40% to 50%
(3) Reporting 10% to 15%
(4) Follow-up 5% to 10%
AUDIT-Best Practices
“5 S Method”
1. Seiri – “Sort, Systematize or Simplify”
2. Seiton – “Straighten, Standardize”
3. Seiso – “Shine”
4. Seiketsu – “Sanitize”
5. Shitsuke – “Sustain”
Ps: “A fool with a tool is still a fool”
Full Proof System Vs Fool Proof System
20. Internal Process Audit
AUDIT-How to Face
•Process Audit and not Person’s Capability
Evaluation
•No Need to Justify the Process (unless it is
asked for)
• Compliance to the process is sought by
Auditor
• Confidence and Ownership (No Fault
Findings)
• Records, Precise Info and Basics of What
You Perform
• Do not give anything more (something not
asked for)
• Always take help of Superior, Subordinate
and colleagues
Communication Protocols
•Light & Polite to be elite
•No Fight to offer Delight
•Absorb all your
insecurity and irritations
•Harmonization
•Confidence Level
21. Internal Process Audit
SHANTIKRUPA
ESTATES PVT LTD
Icons Who Trusted us
Hashmukh
Shah
Group
Government Agencies
UGC-AICTE-INFLIBNET-AMC
Government Corporations
GSFC-GIIC-GAIC-GIDC
GHB
Gujarat
Housing
Board
22. Internal Process Audit
Think Techknowlogically
MSWH-new Generation ERP
Technology
KnowledgeLogic ownership
SolutionTechnique
Techknowlogical
Quality Seekers are
Too BUSY
to be SAD
Too POSITIVE
to be DOUBTFUL
Too OPTIMISTIC
to be FEARFUL
Too DETERMINED to be DEFEATED