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Copyright 2016 Smithers Quality Assessments Copyright 2016 Smithers Quality Assessments

Presented by: John R. Sedlak, Sedlak Consulting - Owner July 14, 2016

ISO 9001:2015

Smithers Quality Assessments

1 Copyright 2016 Smithers Quality Assessments

This will be a “Fast & Furious” overview of what we consider to be some of the most important changes in the standard.

What changed? Short answer – quite a bit! But, don’t “sweat it.” Many of the “changes” are

simple re-wordings or re-positionings of what is in ISO 9001:2008

Introduction



Documented procedures are no longer required. The position “Management Representative” is gone. A separate clause for preventive action no longer

exists. Replaced by “Risk-based thinking.”

Increased responsibility for top management. Number of times ‘planned changes’ appears

Significant Changes



Several changes in terminology, e.g., suppliers are now called external providers.

Number of auditable clauses: ISO 9000:2008 = 5 ISO 9001:2015 = 7

No requirement to re-number your documents, but…….?????

Significant Changes



“Products” is now “Products and Services.” “Exclusion” is now “Application.” “Policy Manual; Procedures; Work Instructions; Records” All now termed “Documented Information.”

“Suppliers” is now included in the grouping called “Externally provided processes, products and services”

“Interested parties” are those that provide significant risk to organizational sustainability if their needs and expectations are not met.

Significant Changes



Time-line for transitioning: ISO 9001:2008 remains in effect until 9/15/2018 Certification bodies are being requested to have

clients already certified to ISO 9001:2008 make the transition to ISO 9001:2015 by the end of 2017.

New certifications to ISO 9001:2008 will most likely cease at the end of 2017

Significant Changes



Risk: The effect of uncertainty

May be positive or negative.

Risk-based thinking: Giving consideration to both positive and negative

issues or conditions. Consider what was previously referred to as

"Preventive Action.”

Key definitions



Risks – addressing them: Avoiding risk; Taking risk in order to pursue an opportunity; Eliminating the risk source; Changing the likelihood or consequences of the risk; Sharing the risk; Retaining risk by informed decision.

Key definitions



Top management: The one person, on-site, that holds the highest

ranking position - may be owner, president, vice president, general manager, or plant or office manager depending upon the organizational structure. NOTE: Responsibilities and authorities can be

delegated, but ultimate ownership belongs to the one, top person.

Key definitions



Highlighted Clauses of ISO 9001:2015

Limited to New & Significant Changes



4.1 Understanding the organization and its context Organization SHALL determine… …external and internal issues that are relevant

to its…. purpose and strategic direction and that affect

its …ability to achieve the intended results of its

QMS. Lets further explore each of these.

Highlighted Clauses:



4.1 Understanding the organization and its context External issues: primarily customers, suppliers (now

known as: Externally provided processes, products and services) and regulatory agencies. Considerations: legal, technological, competitive,

market, cultural, social and economic environments, whether international, national, regional or local.




4.1 Understanding the organization and its context Internal issues: the collection of activities from all

internal processes that make up the QMS. Sources and considerations: values, culture,

knowledge, processes, materials, employees (temporary and permanent), methods, management, tooling & equipment, measurement, etc.




4.1 Understanding the organization and its context Purpose and strategic direction: What is it we do

and what are our plans for the future? Is there an annual planning process in place? If

so, this is the key source of information. If not, you are probably just drifting along on

the inertia created by past events. Ability to achieve intended results of its QMS: Can

we meet all applicable requirements?




4.2 Understanding the needs and expectations of interested parties Determine…. …interested parties that are relevant to the QMS …the requirements of these interested parties

Monitor and review… … information about these interested parties




4.2 Understanding the needs and expectations of interested parties Interested party: any entity that has, or can have, an

influence on the inputs or outputs of the organization. Examples include: customers, regulatory

agencies, suppliers. Could also include bankers, boards, unions, neighbors, certification bodies, just to name a few.

Monitor: Listen, pay attention, planned/periodic review of web sites, etc. There is no excuse for not knowing.




4.4 Quality management system and its processes 4.4.1 ….. The organization SHALL determine the

processes needed for the quality management system and their application throughout the organization, and SHALL: These processes need to match the SQA-78

CRW and need to have ‘criteria’ established (objectives/metrics). More in clause 8.1.




Basic Process Model

Men (people) Materials

Methods

Inputs (in RED)

Process (activities)

Outputs (ultimately, customer satisfaction)

Machines Management

Measurements

Defined Criteria



4.4 Quality management system and its processes 4.4.1f) address the risks and opportunities as

determined in accordance with the requirements of 6.1: Risks: the effect of uncertainty; can have positive

or negative effects. Opportunities: a set of circumstances that make

it possible to do something.

More in Clauses 5 & 6

Highlighted Clauses



5.1 Leadership and commitment: Top management SHALL demonstrate leadership

and commitment with respect to the QMS by: a) taking accountability for the effectiveness

of the quality management system…

New. It puts more responsibility on top management to "own" the QMS.

Leaders establish unity of purpose and direction!




5.1 Leadership and commitment Top management SHALL demonstrate leadership by: b) ensuring that the quality policy and quality

objectives are established ….and are compatible with the context and strategic direction of the organization…

Partly new: Requires tying the policy and objectives to the strategic direction of the organization. Where do we intend to go and how does the QMS

fit into this?




5.1 Leadership and commitment Top management SHALL demonstrate leadership

and commitment with respect to the QMS by: c) ensuring the integration of the quality

management system requirements into the organization's business processes…

The QMS is not a "stand-alone" entity. It must be an integral part of all business processes.

Let’s look at a few examples




5.1 Leadership and commitment Some examples of how this can be done. Flowing down the objectives to applicable

functions (processes) and levels (involved workers). Include milestones, etc.

Holding process owners accountable for these objectives.

Periodic meetings with all employees – led by top management

Highlighted Clauses



5.1 Leadership and commitment Top management SHALL demonstrate leadership

and commitment with respect to the QMS by: d) promoting the use of the process

approach and risk-based thinking…

New - in that management must now emphasize the process approach and risk based thinking.

Highlighted Clauses



5.1 Leadership and commitment Top management SHALL demonstrate leadership and

commitment with respect to the QMS by : h) engaging, directing and supporting persons to

contribute to the effectiveness of the quality management system…

Partly new: Emphasizes the need for top management to be proactive regarding employees and the QMS

Highlighted Clauses



5.1 Leadership and commitment Top management SHALL demonstrate leadership and

commitment with respect to the QMS by: j) supporting other relevant management roles to

demonstrate their leadership as it applies to their areas of responsibility…

New: Emphasizes that responsibility for the QMS in shared by all management. It is not the sole responsibility of the "quality manager.“

Highlighted Clauses



5.1.2 Customer focus Top management SHALL demonstrate leadership

and commitment with respect to customer focus by ensuring that: b) the risks and opportunities that can affect

conformity of products and services and the ability to enhance customer satisfaction are determined and addressed…

Tools for addressing risks and opportunities will be presented in later slides.

Highlighted Clauses



5.2.1 Establishing the quality policy Top management SHALL establish, implement

and maintain a quality policy that: c) be available to relevant interested parties,

as appropriate…

New requirement - to make the organization's quality policy available to interested parties This does not mean wholesale publication.

Highlighted Clauses



5.3 Organizational roles, responsibilities and authorities d) ensuring the promotion of customer focus throughout

the organization; e) ensuring that the integrity of the quality management

system is maintained when changes to the quality management system are planned and implemented.

Not new, but customer focus and dealing with changes is much more emphasized in ISO 9001:2015 than in previous versions.




6.1 Actions to address risks and opportunities 6.1.1 When planning for the quality management

system, the organization SHALL consider the issues referred to in 4.1and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:…

Risk: The effect of uncertainty: May be positive or negative. Opportunity: A set of circumstances that make it possible to

do something.




6.1.2 The organization SHALL plan

a) actions to address these risks and opportunities.

Tools for addressing Risk: S.W.O.T. analysis Preventive Actions Process or Design analysis via FMEA (Failure Mode

Effects Analysis) Monitoring & Measurement of Processes RACI analysis




Risk Analysis Considerations: It is suggested that your organization develop criteria for

when to document risk analysis decisions. Examples: New customers New processes New suppliers Capacity constraints Safety consideration Regulatory changes



Risk Analysis Considerations If possible, incorporate the record of the decision to undertake risk analysis on various forms. (Let the form drive the process; don’t rely on memory.)

Examples: Contract review forms Design review forms Management review records

If you do this, consider adding a section to describe which risk analysis actions are planned, etc.



Some additional ways to mitigate risk: Product Control Plans Use of cross functional teams Change Control Process Succession planning Cross-training Preventive maintenance Effective internal audits and management reviews



6 Planning 6.1.2 (last para.) Actions taken to address risks

and opportunities SHALL be proportionate to the potential impact on the conformity of products and services. You get to decide what actions to take and how

many resources to expend. The emphasis needs to be on decisions

affecting product or service delivery.

Highlighted Clauses



Final thoughts on Risk Management: There is no requirement for formal methods of risk management nor a documented procedure. Your organization determines what level of a risk management process is appropriate. Please remember that not all processes pose the same risk to your organization. You must apply risk based thinking and take actions to address risk. You determine what level of documentation is necessary, if any. Risk management should ADD VALUE!



6.2.1 Quality Objectives (c thru g) …shall…. c) take into account applicable requirements; d) be relevant to conformity of products and services and to

enhancement of customer satisfaction; e) be monitored; f) be communicated; g) be updated as appropriate. The organization SHALL

maintain documented information on the quality objectives. These requirements had been implied, now they are

made specific.




6.2.2 Quality Objectives – planning (a thru e): When planning how to achieve its quality objectives, the organization SHALL determine: a) what will be done; b) what resources will be required; c) who will be responsible; d) when it will be completed; e) how the results will be evaluated. These are the basics of any well-designed plan.




6.3 Planning of changes- When the organization determines the need for changes to the quality management system, the changes SHALL be carried out in a planned manner (see4.4). The organization SHALL consider: a) the purpose of the changes and their potential

consequences; b) the integrity of the quality management system; c) the availability of resources; d) the allocation or reallocation of responsibilities and

authorities.




6.3 Planning of changes- NEW! Change happens! When it does, be sure the integrity of

your QMS remains intact. Examples of changes that can effect the QMS: Change in top management; New customers New processes New suppliers Capacity constraints Safety consideration


RISK !



7.1.6 Resources - Organizational knowledge The organization SHALL determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. Consider: How are new employees trained? Who trains them?

Re-training? What happens when a new process is installed? Knowledge in drawings? Work Instructions? Shop

Travelers? Control Plans?




7.3 Awareness The organization SHALL ensure that persons doing work under the organization's control are aware of: b) relevant quality objectives; c) their contribution to the effectiveness of the

quality management system, including the benefits of improved performance;

d) the implications of not conforming with the quality management system requirements.




7.3 Awareness: In the 2008 version, these requirements were

mostly implied. Now they are explicit. From an auditor’s perspective, it will now be

appropriate to ask any employee about: Policy Objectives (for their process or department) Impact of their job duties on these Benefit of improved performance



7.4 Communication The organization SHALL determine the internal and

external communications relevant to the quality management system, including: a) on what it will communicate; b) when to communicate; c) with whom to communicate; d) how to communicate; e) who communicates.

What is your plan for effective communication?




7.5.1 Documented information - General The organization's quality management system SHALL include: a) documented information required by this

International Standard; b) documented information determined by the

organization as being necessary for the effectiveness of the quality management system.




7.5.1 Documented information – General: NOTE: No required procedures. This does not mean an organization no longer

needs to have procedures. It is now up to the organization to make its own determination regarding procedures, work instructions, etc.

There are numerous places in the standard where “documented information” appears.

Maintaining documented information may be a chosen method to reduce risk….




To gain consensus on how things are to be done To provide a means for training new and transferred

personnel To provide an effective vehicle for communicating

changes To mitigate risk

REMINDER Reasons for creating a procedure:



7.5.3.1 Control of documented information Documented information required by the quality management system and by this International Standard SHALL be controlled to ensure: b) it is adequately protected (e.g. from loss of

confidentiality, improper use, or loss of integrity). Changes to documents make the current document obsolete.

Be sure the user does not use the obsolete document unless warranted. This applies to both internally generated documents and those of external origin.




8.1 Operational Planning and Control The organization SHALL plan, implement and control processes (see 4.4) needed to meet requirements for the provision of products and services, and to implement actions determined in CLAUSE 6 (objectives) by:

b) Establishing criteria for processes; d) Implementing control of processes in accordance with criteria; Let’s look at a few examples. You need to use your defined processes!




Examples of Process Criteria:

Process Criteria/ Metric Actual Purchasing 98% OTD from suppliers

Measured monthly 99%

Production < 2% Scrap : > 87% Utilization Measured by job/ part number

3.1% scrap 89% Utilization

Contract Review < 2% production changes due to equipment capability Measured by job/ monthly

1.7 %

What actions are being taken to correct the scrap not meeting the criteria?



8.1 Operational Planning and Control e) Determine, maintain and retain documented information to the extent necessary: 1) have confidence the processes have been carried out as planned; The organization SHALL control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.




8.4.2 Control of externally provided processes, products and services (aka, Purchasing) - Type and extent of control The organization SHALL ensure that externally provided processes, products and services …The organization SHALL: a) ensure that externally provided processes remain

within the control of its quality management system; An organization cannot abdicate its responsibility

for meeting customer requirements. In other words, you can't simply blame the supplier.




8.4.3 Information for external providers: d) external providers interactions with the

organization e) control and monitoring of the external providers'

performance to be applied by the organization; Define criteria for approving and disqualifying

suppliers. Maintain a list of approved suppliers. Rate their performance on a regular basis, typically

annually. It is okay to “manage by exception.”




8.5.1 Control of production and service provision: c) the implementation of monitoring and measurement

activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services have been met What is the verification your organization will use to

evaluate whether processes have met criteria?




8.5.1 Control of production and service provision: g) the implementation of actions to prevent human

error; It is easy to "blame the operator." But, in most cases, there is something wrong with

the process (tooling, machine conditions, measurement equipment, documentation errors, material issues, training, supervision, etc.).

Is your organization error proofing?




8.5.6 Control of changes: The organization SHALL review and control changes

for production or service provision, to the extent necessary to ensure continuing conformity with requirements.

The organization SHALL retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.

How are you controlling changes?




9.1.3 Analysis and evaluation The organization SHALL analyze and evaluate appropriate data and information arising from monitoring and measurement. The results of analysis SHALL be used to evaluate:

d) if planning has been implemented effectively; e) the effectiveness of actions taken to address

risks and opportunities; Don’t fall in the trap of looking at information only on a

monthly , quarterly or annual basis.




9.3.2 Management review inputs: The management review SHALL be planned and carried

out taking into consideration: b) changes in external and internal issues; c) trends in: 5) monitoring and measuring results;

e) the effectiveness of actions taken to address risks and opportunities (see 6.1);




10.2.1 Nonconformity and corrective action Little new, but this is a good time to re-visit what I

refer to as the 5-C’s Containment Correction Cause determination Corrective action Confirmation




Containment: Determining the extent of the problem In addition to isolating the immediate or proximate

problem, take action(s) to determine if the identified problem: exists elsewhere in inventory… ...or the management system?



Correction: What action was taken to: a) correct the identified problem? b) correct any other problems identified as a

result of the containment action? Correction can be any one of the following: Rework (or change the documentation) Repair Re-grading Use as it (with approval) Scrap



Cause determination: The root-cause should be focused on what part of

the management system failed and why it failed. Human error is generally not an acceptable response.

Generally, there are two basic questions to ask: What failed in our management system that

allowed the problem to: Occur? Not be detected when it occurred?



Corrective action: Define the specific changes to the management

system that were taken to address the identified weakness in the management system that allowed the original and, as applicable, other identified problems to exist – goal is to ensure that the identified condition does not recur.

Do not confuse this with “correction.”



Corrective action (cont’d.): Corrective actions must make sense and be directly

related to what was defined as the root cause(s). NOTE: There may be more than one cause – see

previous slides. If so, there will need to be at least one corrective

action for each defined cause.



Confirmation: Details of the specific actions taken to provide

assurance (verification) that: a) the corrective actions are, and continue to be,

effective; b) the corrective actions did not result in new

failures in other parts of the management system.

Think: “Special Audit”



10.2.1 Nonconformity and corrective action One new requirement: e) update risks and opportunities determined

during planning, if necessary;




S.W.O.T. analysis Preventive Actions Process or Design analysis via FMEA (Failure Mode

Effects Analysis) Monitoring & Measurement of Processes RACI analysis Succession planning Cross-training Preventive maintenance Effective internal audits and management reviews

Summary of Risk Management Tools



SQA prefers that you upgrade to ISO 9001:2015 by the end of 2017

Obtain a copy of the ISO 9001:2015 standard www.asq.org

Form a “transition team” The team needs to consist of all process owners! DO NOT LEAVE IT UP TO YOUR QUALITY

MANAGER TO DO ALL THE WORK!!!!

Next Steps:

http://www.asq.org/



Decide whether or not to re-number and/or re-name your documents.

Example: Current purchasing procedure is numbered & named “P-7.4, Purchasing” Options: New number: P-8.4, Purchasing (or, “P-8.4, Control of externally

provided processes, products and services”) New number: BP-X, Purchasing (or, “Control of externally provided

processes, products and services” - The “BP” stands for Business Process)

No number: Simply a title: Purchasing (or, “Control of externally provided processes, products and services”)

Next Steps:



Decide which Risk Management tools to use. Make any needed changes. Let the changes “work” for 2-4 months. Execute an internal audit of the entire system. Follow this with a management review meeting. Contact your assigned SQA auditor and let them know

that you are ready for the upgrade process. It can occur at: A surveillance audit A recertification audit

Next Steps:



Thanks for your attention and participation My contact information:

John Sedlak Sedlak Consulting 36 Auburn Ave. S.E. North Canton, OH 44709 Cell: 330-936-3436 Email: [email protected] Web: www.sedlakconsulting.com

Thank You and Goodluck on your Transition!!!

mailto:[email protected]://www.sedlakconsulting.com/

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