Gap analysis is a self assessment practice by an organization directly or through some consultant to match its current Quality Management System (QMS) with the requirements of ISO 9001: 2008 and to find the opportunities to improve the deficiencies in future. If an organization is interested in compliance its QMS with ISO 9001, an effectively done gap analysis can help even the requirement of infrastructure, required documentation, finances needed and approximate time it will take to implement changes and getting certified.
Metro Hi-Tech started motorcycles manufacturing in 2003 and so far is not an ISO 9001 certified company. The gap analysis shows the current status of QMS implementation and the gap yet to be filled if the company wants compliance with the requirements of ISO 9001-2008
Introduction of ISO 9000 family
ISO 9000 series of standards addresses the Quality Management in organizations. This requires from organizations to fulfill customers’ requirement of quality, applicable statutory and regulatory requirements, to enhance customer’s satisfaction and achieve continual organizational performance improvement.
In ISO 9000 family, ISO 9001: 2008 is the only standard against which the organization may be certified. This standard is generic in its nature and gives set of standardized, requirements for a quality management system and with global consensus on these requirements.
The organization, regardless of this size, type, being public or private, manufacturing or service oriented can be certified against this standard. The standard lays down what requirements any QMS should meet and leave it on the organization that haw they meet. This gives enormous flexibility for implementation in any organization.
ISO 9000 series of standards is based on Eight Quality Management System Principles namely;
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach to Management
Continual Improvement
Factual Approach to decision making
Mutually beneficial supplier relationship
These principles can be used as guiding frame work for performance improvement and implementing ISO 9001: 2008 with maximum effectiveness.
The operating principle of ISO 9000 standards system is famously known PDCA cycle.
This cycle provides guideline to process every task, improve any process or service any activity by first planning, then implementing the plan, checking the status and then act to improve it.
Check
Act
Do
Plan
PDCA Cycle
In ISO 9000 series there are two types of standards
Quality Management Systems Requirements e. g. ISO 9001: 2008 the only standard for certification.
Guidelines e. g. ISO 9000: 2000 and ISO 9004: 2000 these are general guidelines for understanding requirements. There are also sector specific guidelines standards such as ISO TS-16949 for automotives, IWA 2: 2007 for education and IWA 1: 2005 for health services organizations.
Companies interested in certification of ISO 9001: 2008 are audited by certification bodies and if found complying with the given requirements are given certifies valid for these years.
Effectively implemented and maintained QMS can certainly benefit on organization whether it is customer satisfaction, process improvement, better quality of product, reduction in wastes and increased profit margins.
Process Based Model of Motorcycle Assembling
Customer (Requirements)
Customer (Satisfaction/ Feedback)
Output
ACT
CHECK
PLAN
DO
Gap Analysis
ISO clause
Key Requirement
Yes/No
Current Status/Gap
Improvement required
5. 4. 1
Quality objectives of production, procurement & QC are established.
Yes
5. 4. 1
Quality objectives are measurable and quantifiable.
Not all objectives are measurable
Some of the Objectives need to be quantified.
5. 5
Responsibilities & authorities are clearly defined & communicated.
Yes
5. 5. 3
Appropriate communication processes and means are established.
Yes
5. 6
Do the performance measured reviewed & reported against quality objectives.
No
No regular review
A formal procedure for monitoring of performance against quality objectives should be followed
6. 2. 1
Is the required competence of personnel, performing jobs affecting quality of work, is defined.
Yes
6. 2. 2
Are the trainings are provided based on training needs
Yes
Internal On-Job Training are provided
Off the shelf trainings for specialized work should also be provided.
ISO clause
Key Requirement
Yes/No
Current Status/Gap
Improvement required
6. 2. 2
Trainings effectiveness is evaluated through the results
Formal Evaluations are not performed
Need to formalize this procedure for effectiveness
6. 3
Is the departmental work space, process equipment and supporting services are established
Yes
6. 4
Is the required work environment is determined & maintained in various sections to achieve conformity of the product e. g. cleanliness & dust free environment in engine shop & paint shop, controlled humidity & temperature in paint shop etc.
Yes
7. 1
Is the quality plan for product established
No
No quality plans
There is need to establish a formal quality plan addressing all requirement for manufacture of product.
7. 2
Is the requirements of product (customer, regulating or other) specified and being followed
Yes
7. 2. 2
Do the production has ability to meet these requirements
Yes
ISO clause
Key Requirement
Yes/No
Current Status/Gap
Improvement required
7. 2. 3
Is there any established means of communication to and form customer
Yes
Daily Feedback Reports from Market.
Free Service Camps
7. 4. 1
Is there a system of supplier evaluation implemented
No
No formal system
There is need to establish such system
7. 4. 1
The criteria of selection and evaluation and a list of approved supplier available.
No
No criteria exists
There should be a criteria for evaluation and approval of suppliers
7. 4. 2
Do purchasing requirements properly communicated to purchase department
Yes
Manual Requisition on Paper
Requisition through Software
7. 4. 2
Are purchase requirements communicated to vendors / suppliers in documented from
Yes
Purchase Orders
7. 4. 3
The purchased products are properly inspected against requirements
Yes
All incoming supplies are subject to inspection
7. 5. 1
Is proper information regarding the specification & characteristics of product available
Yes
Drawings and/or Check Sheets
ISO clause
Key Requirement
Yes/No
Current Status/Gap
Improvement required
7. 5. 1
work instructions for personnel performing work are available
No
No written Work Instruction
Written Work Instruction should be there
7. 5. 1
is the equipment suitable to perform work available
Yes
7. 5. 1
The monitoring and measuring equipment is available.
Yes
7. 5. 3
during realization process the product status is identified w. r. t monitoring & measurement
Yes
Job Cards etc
7. 5. 5
the preservation of product is ensured during internal processing and delivery to maintain conformity to requirements
Yes
Designated areas for in-process and finished products
Specialized delivery vehicles.
7. 6
the measuring and monitoring equipment is calibrated and/or verified at specified intervals
Yes
Periodic Calibration of all equipment is made.
7. 6
Measuring equipment is identifiable and protected from damage during handling, maintenance & storage
Yes
8. 2. 3
Measurement & monitoring of processes is carried out during realization process
Yes
Viscosity of paint
Oven Temperature in Paint Shop etc
ISO clause
Key Requirement
Yes/No
Current Status/Gap
Improvement required
8. 2. 4
The product is monitored and measured during realization processes is done
Yes
Torque testing
Engine testing
Bike testing at simulation bench
8. 3
Product which does not conforms to requirement is readily identifiable to prevent its unintended sue.
Yes
The Status on Job Card Provides info.
OK Sticker is pasted to only conforming products.
8. 3
A documented procedure is established to define the control & responsibilities for dealing with N. C product
No
No documented procedure
A well established procedure is required
8. 3
When Non Confirming Product Is Corrected It is again verified.
Yes
The product again goes through the inspection process
8. 4
Appropriate data to demonstrate the suitability and effectiveness of system is collected & maintained.
Yes
PDI section data
Daily feed back
Production reports
Inspection reports
Rejection analysis
8. 5
Corrective actions, preventive actions are taken to eliminate the cause of non conformities & any potential defects.
Yes
8. 5
A documented procedure is established for corrective & preventive actions.
No
No formal procedure
There should be a formal procedure for corrective and preventive actions being taken
Conclusion
Although Metro-Hi Tech is not ISO-9001 certified but the gap analysis shows that there may be significant improvements in production by focusing on monitoring of process and product and standardization of procedures.
Like other Pakistani organizations the biggest challenge for Metro is to properly define its strategic direction and the objectives to be achieved with a defined time line and reviewing the progress on regular basis.
Lack of standardized procedures is another weak area which results in non-standardization of process, inspections and reporting. The criteria for evaluation, selection and re-evaluation of the suppliers can minimize many of the problems of late, inconsistent and wrong supplies with reducing the number of defective parts.