demystifying “organizational context” and “risk based...
TRANSCRIPT
Demystifying “Organizational Context” and “Risk Based Thinking”
in the new QMS Standards
Presented By: Bob Gilbert
Welcome to Demystifying the QMS
Training Goal: Understanding the New QMS’s Learning Objectives:
What are the components of Organizational Context What is meant by Risk Based Thinking How to Identify Risk within our Procedures How to Identify Risk within our Processes How to use a SIPOC-R to Analyze Risk
Let’s Get Started!
Introductions Tell us your name? What Company are you with? Your specialty? Knowledge level of:
ISO 9001:2015 AS9100D
Context of the organization
Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose
and its strategic direction and that affect its ability to achieve the intended result(s) of its QMS.
What is Context?
Background Setting Environment Framework Situation Perspective Circumstance
Statutory and Regulatory Requirements
Statutory: A statute is a formal written enactment of a legislative authority that governs a state, city or country. Typically, statutes command or prohibit something, or declare policy. Statutes are rules made by legislative bodies.
Statutes: OSHA requirements, Fire safety, ADA accommodations, PPM water pollutantdischarge, anti-discrimination, etc.
Statutory and Regulatory Requirements
Regulatory: In business, industry self-regulation occurs through self-regulatory organizations and trade associations which allow industries to set rules with less government involvement.
Regulate: Output, pricing, certifications, (ISO, AS, UL, CE) etc.
Context of the organizationUnderstanding the needs and expectations of interested parties
Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:a) the interested parties that are relevant to the quality management system (WHO); (Hint: VOC, VOB, VOE)b) the requirements of these interested parties that are relevant to the quality management system (WHAT).
The organization shall monitor and review information about these interested parties and their relevant requirements
(WHEN).
Risk Based Thinking
When planning for the quality management system, the organization shall consider the issues referred to in Section 4 and determine the risks and opportunities that need to be addressed.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
Where do we Experience Risk
In our Procedures In our Process
Risk in our Procedures - ExampleP-400 “Organizational Context”
Purpose/Scope The purpose of this procedure is to ensure that the
context of the Company and the needs and expectations of interested parties are understood.
The procedure applies to the external and internal issues that can affect the Quality Management System (QMS).
Risk in Your ProceduresP-400 “Organizational Context”
7.0 During the development of the Organizational Context Procedure it is important to identify interested parties and Regulatory/Statutory requirements. The risks of not identifying can result in the following: Change in regulations that the Company is unaware of Out of compliance with regulations/statutory
requirements Not understanding changing needs of interested parties Loss of business in specific markets Unfavorable revenue impact
Risk in Your Process
Process Risk SIPOC-RSuppliers Inputs Process Outputs Customers Risk
Quoting
Receive P.O. & create Sales Order
Order Review
Sales order entered into System
Order entry holds file until invoicing.
Operations Checks Parts Inventory
Product assembly
Process Risk SIPOC-RSuppliers Inputs Process Outputs Customers RiskCustomerProviders
Operations
RFQQuotes
Schedule, costing
Quoting
Customer Purchase Order Receive P.O. & create Sales Order
Sales Order entry form and customer P.O.
Order Review
Order Entry Approved Sales Order
Sales order entered into System
Sales / Management
Sales order/file folder back to Order Entry
Order entry holds file until invoicing.
Sales/Management
Picking & Packing Lists
Operations Checks Parts Inventory
ProductionSuppliers
Picking list packing list and parts
Product assembly
Process Risk SIPOC-RSuppliers Inputs Process Outputs Customers RiskCustomerProviders
Operations
RFQQuotes
Schedule, costing
Quoting Quote Customer
Customer Purchase Order Receive P.O. & create Sales Order
Order entry FormCustomer P.O.
Sales
Sales Order entry form and customer P.O.
Order Review Approved Sales Order
Order entry
Order Entry Approved Sales Order
Sales order entered into System
P.O., Sales order, picking list, packing
list, file folder created
Sales / Management
Sales / Management
Sales order/file folder back to Order Entry
Order entry holds file until invoicing.
Sales order folder Order entry
Sales/ Management
Picking & Packing Lists
Operations Checks Parts Inventory
Picking and Packing lists to production
and order parts P.O. if required
ProductionSuppliers
ProductionSuppliers
Picking list packing list and parts
Product assembly Finished goods Testing
Process Risk SIPOC-RSuppliers Inputs Process Outputs Customers RiskCustomerProviders
Operations
RFQQuotes
Schedule, costing
Quoting Quote Customer Order not taken correctly.Wrong discount applied.On-time delivery.
Customer Purchase Order Receive P.O. & create Sales Order
Order entry FormCustomer P.O.
Sales Misinterpretation of P.O. or customer requirements.
Sales Order entry form and customer P.O.
Order Review Approved Sales Order
Order entry Missed details, typos, shipping details.
Order Entry Approved Sales Order
Sales order entered into System
P.O., Sales order, picking list, packing
list, file folder created
Sales / Management
Missed details, typos, shipping details
Sales / Management
Sales order/file folder back to Order Entry
Order entry holds file until invoicing.
Sales order folder Order entry Misfiled or lost
Sales / Management
Picking & Packing Lists
Operations Checks Parts Inventory
Picking and Packing lists to production
and order parts P.O. if required
ProductionSuppliers
Parts delay
ProductionSuppliers
Picking list packing list and parts
Product assembly Finished goods Testing Assembled improperly, parts out of tolerance, unavailability of parts, poor training, assembled to the wrong rev, tools not available.
Value Added using the SIPOC-R
Helps you to defines the Inputs and Outputs for each step in your Process
Defines the Source of each Input Identifies each Output with its associated User It’s used as a Brainstorming Template for
defining Risk aligned with each Process Step
Risk/Opportunity WorksheetProcess Process Risk Customer
ImpactChangeability
IndexPerformance
StatusBusiness
ImpactWork
ImpactTotal Rank
Quoting
Order not taken correctly
Wrong discount applied
On-time delivery
Receive P.O. & create Sales Order Misinterpretation of P.O. or customer requirements
Order Review Missed details, typos, shipping details
Sales order entered into Sage Missed details, typos, shipping details
Order Entry holds file until invoicing.
Misfiled or lost
Operations Checks Parts Inventory Parts delay
Product assembly
Assembled improperlyParts out of toleranceUnavailability of partsPoor trainingAssembled to the wrong revTools not available
Risk/Opportunity Worksheet CriteriaCustomer Impact: How much does the customer care?
1 = Low customer priority 4 = Very important to the customer
Changeability Index: Can you fix it? 1 = Relatively easy / cheap to fix 4 = Very Difficult / Expensive to fix
Performance Status: How broken is it?
1 = Only a few problems in the past 4 = Always seems to be causing problems
Business Impact: How important is it to the business?
1 = Has little impact on the business 4 = Is very important to the business
Work Impact: What resources are available? 1 = People who have capability to work on this activity can be available 4 = People who have capability to work on this activity are scarce
Risk/Opportunity Worksheet – Do in ExcelProcess Process Risk Customer
ImpactChangeability
IndexPerformance
StatusBusiness
ImpactWork
ImpactTotal Rank
Quoting
Order not taken correctly 4 1 1 4 1 16
Wrong discount applied 4 3 1 3 1 36
On-time delivery 3 3 1 3 1 27
Receive P.O. & create Sales Order Misinterpretation of P.O. or customer requirements
4 2 2 3 1 48
Order Review Missed details, typos, shipping details
3 2 2 3 1 36
Sales order entered into Sage Missed details, typos, shipping details
3 2 1 3 1 18
Order Entry holds file until invoicing.
Misfiled or lost 1 1 1 1 1 1
Operations Checks Parts Inventory Parts delay 4 2 2 4 1 64
Product assembly
Assembled improperly 4 4 1 4 1 64Parts out of tolerance 1 3 1 3 1 9Unavailability of parts 3 3 1 3 1 27Poor training 2 1 1 2 1 4Assembled to the wrong rev 1 1 1 1 1 1Tools not available 1 2 1 1 1 2
Risk/Opportunity WorksheetProcess Process Risk Customer
ImpactChangeability
IndexPerformance
StatusBusiness
ImpactWork
ImpactTotal Rank
Quoting
Order not taken correctly 4 1 1 4 1 16
Wrong discount applied 4 3 1 3 1 36
On-time delivery 3 3 1 3 1 27
Receive P.O. & create Sales Order Misinterpretation of P.O. or customer requirements
4 2 2 3 1 48
Order Review Missed details, typos, shipping details
3 2 2 3 1 36
Sales order entered into Sage Missed details, typos, shipping details
3 2 1 3 1 18
Order Entry holds file until invoicing.
Misfiled or lost 1 1 1 1 1 1
Operations Checks Parts Inventory Parts delay 4 2 2 4 1 64
Product assembly
Assembled improperly 4 4 1 4 1 64Parts out of tolerance 1 3 1 3 1 9Unavailability of parts 3 3 1 3 1 27Poor training 2 1 1 2 1 4Assembled to the wrong rev 1 1 1 1 1 1Tools not available 1 2 1 1 1 2
Continual Improvement
Risk calculation: 1x1x1x1x1=1 4x4x4x4x4=1024
Focus first on “Low Hanging Fruit” Focus second on “Highest Number” risk ranking Eliminate the risk, then move on to the next one
Questions
Revision History
Rev A – 11/7/2017 ASQ 1515 (RBG)