6/25/2010

Agenda

ISO 9001 Awareness •

•
General introduction on ISO
Diff between process determination Vs process
identification
By • What is process approach
• Process Indicators – Effectiveness Vs Efficiency
Suhas Agawane • Macro view of ISO 9001 framework
• Amendment vs revisions of documents
Chief Consulting Officer
• Importance of document control
Simple Solutions Consultant • Records are means to captured data and further to generate
information through it
• Understanding fundamental terms
• Clarity of understanding among terms correction ,
corrective action , preventive action
• Continued

Agenda General Info – ISO Standards

• ISO standards are published by International Organization for
• MRM meeting requirements
Standardization
• What Quality policy & objectives means for various
department • ISO has it’s head quarters at Geneva and more than 180
countries are members of this institution
• P-D-C-A / Demings Cycle
• ISO publishes various standards on technical specs , testing
• Outsourced process control ( Why & how) methods as well as management systems
• Supplier Capability Assessment • In management system domain , following standards (which
• Quick read through ISO 9001 Standard Requirements are relevant to constructions sector) are available from ISO
ISO 9001 (QMS) ISO 9000 (Vocabulary)
ISO 14001 (EMS) ISO 9004 (Performance Improvement Guideline)
ISO / OHSAS 18001 (Safety) ISO 10007 (Project Mgt Guidelines)
ISO 27001 (ISMS) ISO 19011 (Audit Guidelines)

• ISO certificates are issued by certification bodies (CBs) & these

CBs are authorized to do so by accreditation boards
• ISO certificates are valid for 3 yrs. There are surveillance audit
conducted by CB every yr & re-registration audit every 3 years
• Latest standard edition for ISO 9001 is 2008. Superseded
editions includes 2000 , 1994 , 1987

What is Process Process Mapping

Inputs Purchasing Outputs
• Required item / Process Steps • Receipt of Materials
quantity / date on right conditions
• Applicable specs • Right Quality, Right
• Supplier source Quantity
• Suppliers capability Interactions to • Right Time.
to meet our •Storage
requirements •Inspection and Testing
•Manufacturing
•Finance

Customers
Suppliers Performance Measurements
•Production
•Finance •Delivery status – On-time, On
spec, NCP etc •Stores

• Continued •Supplier evaluation • Continued

1
 6/25/2010

Process identification Vs determination Marco View of ISO 9001 Framework

• Process Identification – picking up what is appearing in

business operation
• Process Determination – exploring what is required for
business operation
• So for determination business context is important

• Continued

Marco View of ISO 9001 Framework Documentation Structure

4 Quality 5 Management 6 Resource 7 Product 8 Measurement • Quality Manual - Summarized information how Org‘s
Management Responsibility Management Realization Analysis & systems addresses ISO requirements
System Improvements
Requirements • Process Manual – Detailed information how organization’s
management processes are executed , controlled and
General
Management
Provision of Planning
managed
Commitment General
Requirements Resources • Procedure Manual – Documented procedural steps to be
Documentation
Customer Focus
Human
Customer Monitoring & followed w.r.t. specific ISO / Org‘s requirements
Related Measurements
Requirements Resources Processes • Forms – Structured document to be used as generating for
Quality Policy
Control of NCP’s different types of records
Infrastructure Design &
Development • Record Content (RC) – List out essential information
Planning Analysis of Data
Work component / details that particular record should contain. It
Environment Purchasing
is free form to be used generating specific type of records
Responsibility, Improvements
Authority & Production &
Communication Service
Provision
Management
Reviews Calibration

Document Control Record Control

• Document – The source of information where information is
• Record – These are special type of documents .
dynamic
It is post event / action outcome
• Use of Document –
Once prepared can’t be changed
– Action criteria
– Reference information for monitoring / execution • Interesting examples regarding records–
– Basis for decision making – Death Will
• These can be in any form – Degree / Birth Certificate
– Purchase Order (Before Vs After Receipt)
• Why need control
– Blank form Vs Filled up form
– Dependability
– Project Plan Vs Project Review record
– Authenticity
– Likelihood of changes
• There are no revisions for record , but it might get amendment
– Information is collated in context of business • They can be in any form – hard / soft copy , database files
• What controls • Use of Record
– Check for correctness – Evidence what happened
– Management/ Authority Endorsement – Framework for gathering relevant data for various information
– Know latest changes – Statutory & regulatory requirements
• Continued
– Change counter reference – To establish traceability
– Periodically reflect business context / changes into document

2
 6/25/2010

Record Control Understanding fundamental terms

• Attribute for record use , influencing type of control

Requirement Characteristic
– Records are kept for substantial period even 10 – 20 years
– Records are likely to be recalled any time during it’s retention period Need or expectation that is Distinguish feature
– Records may be recalled a another person/s who has not kept it stated, generally implied or
initially obligatory
– Records might contain crucial information
• Principal of Record – Record in the File and File is at the Quality
location Conformity Degree to which a set of
• Records controls include Fulfilment of requirement inherent characteristics
– To list out fulfils requirements
– Retention period
– Filing approach to facilitate easy retrieve - ability over complete
retention period as well as by another person
– Access & disposition Grade
– Prevent deteroriation / damage of record during retention period
Nonconformity Category or rank given to different
Non Fulfilment of quality requirements for products
requirement ,, processes or systems having the
• Continued
same functional use

Understanding fundamental terms Mastering CA-PA

DISPOSITION CONFORMITY
• Corrective action (CA) – does ensure the similar NCs does not
Action taken to resolve a T recur again or it’s frequency reduces
non-conformity situation E DEFECT
M NON CONFORMITY (NC) • Preventive action (PA) – does ensure that potential NC does
Non-fulfilment of a
SCRAP P Non-fulfilment of a requirement related to an not occur or it’s probability reduces
requirement intended or specified use. • Steps for CA – PA
ALTERNATE USE S
O
RE-GRADE L PERMENANT / LT SOLUTIONS
DEVIATION / U
CONCESSION T
I CORRECTIVE ACTION PREVENTIVE ACTION
CORRECTION O Action to eliminate the Action to eliminate the
Action to eliminate a a N cause of a detected NC or cause of a potential NC or
detected nonconformity S other undesirable situation other undesirable situation
A. Evaluate need for CA/PA
B. Root / Vital cause/s analysis
C. Working appropriate action/s to eliminate these root /vital cause /s
D. Authorization of action /s plan /s
REWORK REPAIR E. Deployment / implement plans
Action on NC product to make Action on a NC product to make F. Monitor outcome
it conform to the requirements it acceptable for the intended use G. Verify effectiveness

MRM Meeting Requirements What is mean by Policy & Objective

• MRMs are conducted periodically once in 3/6 months • Policy gives direction and framework for operational activity
• Objective of MRM is to review organizational process focus as well as decision making
performance review • Various elements of policy needs to be interpreted by
• Important agenda includes following concerned functional team in terms how it is relevant to them
– Quality objective and process indicator status review • Certain elements relevant to all functional team where as some
– Internal audit result review are relevant to few functional team
– Review of customer complaints , satisfaction and feedback • Objectives are statement on performance goals with targets
– Resource requirements and training plan • Quality Objectives are at apex level and responsibility is
– Improvement planned – Analysis reports and CA-PA status assigned to main contributing function
– Review of previous MRM decisions / actions
• Various other functional team then needs to contributed
– BEM re-visit and QMS changes
through supporting these objectives in it’s relevant functional
– Project performance (Cost-Time-Quality)
parameter
• Concerned HODs needs to present following during meeting
• These objectives should & can be linked to appropriate
– Process indicator status and data
process indicators for various functional team
– Departmental analysis report & CA-PA Log
– Actions for & status of internal audit NCs • Objective targets needs to be SMART
– Status & progress on actions from previous MRM Stretchable , Measurable , Achievable , Relevant , Time-bound

3

PDCA (Demings Cycle)
• It talks about the continual improvements in small steps which
are cascaded
• Plan the actions > Execute the actions > check the outcome
> take necessary corrective measures wherever results are
not as expected
Outsourcing process control
(Why & How)
• Next step is to discuss what kind of controls the specific
supplier can establish for these applicable requirements
• For non addressed requirements , then workout suitable
alternate controls that organization should put in place
• If supplier is ISO certified , organization may consider this
third party certification for it’s control
6/25/2010
Outsourcing process control
(Why & How)
• Organization buys products & services
• These products & services are of three categories
a. Supplier’s own branded / standard products
b. Products & services supplied as organization requirements and
of which quality can checked through inspection
c. Products & services supplied as organization requirements and of
which quality can not be checked through inspection
• The category ‘c’ case is called as outsourcing
• This outsourcing in some cases goes complete back to back
activity e.g. – Third party licensing manufacturing of pharma
products , Complete construction work sub-contracting
• Whether you carry out the process or your supplier , ISO 9001
requirements must be met.
• So in outsourcing process control , first thing required is to
identify which are ISO 9001 requirements shall be applicable
for particular out sourced
• Continued
Supplier Evaluation
• Supplier’s evaluation is carried out from two perceptive
• (I) Supplier’s capability assessment / re-assessment
– In this focus to assess supplier facilities , capability ,
credibility
– This is required to be done fore selection of supplier
– Periodic re-assessment to re-assess changes if any in above
• (II) Supplier’s performance evaluation
– In this objective is to review how was the performance of
supplier for purchase transaction done during specified period
– Performance factor generally include Quality , Timely delivery ,
Price and Support
– Outcome of evaluation – rating , CAs , delisting
• Capability assessment & performance evaluation criteria can
vary based on type of products & services