Why we should follow ISO 9001-2015 standard in our organisation?

         Hi, Friends some times we heard few casual comments about system standards like " ISO ne kuch fayda nahi hua? (ISO certification doesn't gave any benefit). Most of the time people consider it as a hurdle in their day to day work. If you follow it without understanding the intent then definitely its a burden or load on your head/ hurdle in your work. Standards guide us to work in a structured way & every step in a structured methodology is always having micro benefit which adds value to our process of meeting goal or objective. In practice we deviate structured way & go for short cuts to meet aggressive time line. This leads us to deviate from right path of structured methodology defined in standards. 

       Following are the key potential benefits of implementing quality management system (QMS) based on international standard.

1. the ability to consistently provide products & services that meet customer & legal requirements.
2. facilitating opportunities to enhance customer satisfaction
3. addressing risks & opportunities associated with its context and objectives
4. the ability to demonstrate conformity to specified QMS requirements

This international standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking.

a) What is Process Approach?

       This approach enables the organisation to control the interrelationships and interdependencies among the processes of the system so that overall performance of the organisation can be enhanced.

Process approach involves 

• systematic definition and management of processes & their interactions
• to achieve intended results in accordance with Quality Policy & strategic direction of the organisation
• using PDCA cycle with focus on risk based thinking aimed at taking advantage of opportunities and preventing undesirable results.

Application of process approach enables

• understanding and consistency in meeting requirements
• the consideration of processes in terms of added value
• the achievement of effective performance
• improvement of processes based on evaluation of a data and information

Schematic representation of the elements of the process

a) What is Risk based thinking?

         

      Risk based thinking is nothing but to determine the risk and opportunities that need to be addressed to 

• give assurance that the QMS can achieve its intended results
• enhance desirable effects
• prevent or reduce undesired effects
• achieve improvement

and plan actions to address these risk and opportunities. 

     This international standard doesn't have separate clause on preventive action. The concept of preventive action is expressed through the use of risk-based thinking in formulating QMS requirements. Standard doesn't insist any formal methods for risk management or documented risk management process. However, organisations can show evidence of risk based thinking by various methods such as SWOT analysis, DFMEA, PFMEA, Risk register etc. suitable to organisation.

  If we need benefits of this international standard then we should follow principle of Adequacy, Adherence and Effectiveness of QMS through PDCA cycle till we meet  quality objectives of our organisation. There is no other way..............

Organisation Structure

         Above organisation chart is showing typical organisation structure of any automotive manufacturing OEM/ Supplier. Every element in the chart will have unique function, however depending on the organisation strategy, scope, manpower availability, responsibility is assigned to employees. Sometimes in small organisations many functions are clubbed together and assigned to the single employee or in large organisations functions are broken in sub functions and assigned to the more number of employees. No matter all functions are important for any manufacturing organisation irrespective of whether employee is part of organisation ie. on employer role or outsourced to external agency like recruitment of manpower, Maintenance, Administration is outsourced etc.

Brief function of all functions in the organisation structure.

Business Head : He is highest authority in the organisation. All functional heads report to Business Head.

Research & Development:

Product Planning (1) :

To plan new product as per the current and future needs of the Customer. Product concept finalisation. To plan long term product strategy 

Design (2) :

To finalise design goals & specifications along with product planning. Convert design goals in part drawings and specification sheets.

Testing & Reliability (3) :

To make prototypes and test it in simulated customer environment and give feedback to design for making corrections. To measure & anticipate reliability & warranty life of product based on testing results.

Manufacturing Engineering (4) :

To plan Facility, Tooling & gages for new products, establish it and handover to production.

Administration (5) :

To monitor day to day requirement of employees in office & plant such as cleanliness, staff requirement, event management, security management etc.

Manufacturing (Production) :

Production Planning & Control (6) :

To plan daily, weekly and monthly schedule for production. ie models, colour combinations, Quantity and sequence of production based on requirement received from sales.

Maintenance (7) :

To maintain all equipment, fixtures, machines, tools, facility in plant in working condition as and when required by production.

 Power Planning & Supply (8) :

To do centralised power planning of electricity, fuel gas, compressed air supply and disposal of waste as per sustainibility guidelines.

Tool Room (9) :

To maintain dies and fixtures. Make spare parts of machines, equipment as per need from maintenance department. Carry out tool regrinding activity till life of tool is over particularly for HSS tools such as drills, hobs, shaving cutters, brazed tools etc. To make new tooling, fixtures as per need.

Marketing (10) :

Identify new customer base, Channel development, Dealer readiness for new products, Dealer Training, support product planning for market survey.

Sales (11) :

Enquiry generation and conversion for sale. Dealer wise yearly planning for sale.

 After Sale Service (Customer Care) (12) :

To provide service to customer for repair and maintain the product performance. Warranty settlement of parts replaced within warranty by dealership. Organise technical training to dealership personnel.

Quality :

Manufacturing Quality (13) :

To ensure product quality during manufacturing as per the specification on part drawing.

Supplier Quality (14) :

To ensure product quality of parts supplied by vendor or supplier.

Field Quality (15) :

To get feed back of field failures of parts at customer end from Customer Care and to take action on design, at manufacturing and at supplier end so that defect free product will be supplied to the customer in future.

Quality Planning (16) :

To ensure quality before launch of new product during Design, Manufacturing and at supplier end by ensuring all requirements of QMS are adhered such as Design Review, DFMEA, PFMEA, DVPR, Proto Testing etc.

Human Resources (17) :

Human resource planning & recruitment as per need. Training and development of employees. Ensure Personal & Industrial relations among employees.

Supply Chain Management (18) :

Ensuring supply of right quantity of parts of right models from suppliers by procuring it  as per schedule released by Production Planning & Control. 

Part Development (19) :

Part development at supplier as per time line of new projects.

Accounts & Finance (20) :

Financial planning, reporting and controls, investments, cash management , risk management, auditing and accounting.

 Program Management (21) :

To ensure projects are meeting Quality, Cost & Time targets.

NOTE:  

All above functions are documented briefly in generic way, however it would differ organisation to organaisation. More specific details are available in respective organisation's QMS Apex manual.

courtesy: https://ungliiart.com/TrainingDetails.php

Abbreviations of QMS (Quality Management System)

 Abbreviations 

• APQP     :  Advance Production Quality Planning
• CAPA      : Corrective and Preventive Action
• CIR         : Customer Input Requirements
• Cp, Cpk  : Process Capability Indices
• CFT        : Cross Functional Team
• CPQ       : Customer Perceived Quality
• CKD        : Completely Knocked Down
• CAD        : Computer Aided Design
• CAE        : Computer Aided Engineering
• CSI          : Customer Satisfaction Index
• DWM       : Daily Work Management
• DR           : Department Representative
• DR           : Design Review
• EWT        : Effective Work Time
• FMEA      : Failure Mode & Effect Analysis
• FEA         : Finite Element Analysis
• FTG         : Facilities Tooling & Gages
• DVP        : Design Verification Plan
• DVPR     : Design Verification Plan & Report
• ICA         : Interim Containment Action
• IQA         : Internal Quality Audit
• IQS         : Initial Quality Study
• ISO         : International Organisation for Standardisation
• KPI         : Key Performance Indicator
• KRA        : Key Result Area
• MOP       : Measure of Performance
• MIS        : Month In Service
• MR         : Management Representative
• MSA       : Measurement System Analysis
• MRM      : Management Review Meeting
• MTBF    : Mean Time Between Failure
• MTTR    : Mean Time To Repair
• NVH      : Noise , Vibrations and Harshness
• PPM      : Parts Per Million
• PSW     : Part Submission Warrant
• PFC      : Process Flow Chart
• PFD      : Process Flow Diagram
• PFMEA : Process Failure Mode & Effect Analysis
• PDCA    : Plan Do Check Act
• PDSA    : Plan Do Study Act
• PCA      : Permanent Corrective Action
• PPAP    : Production Part Approval Process
• SPC      : Statistical Process Control
• QFD     : Quality Function Deployment
• QMS    : Quality Management System