Getting The Contex Right: Using Simple SWOT Analysis to Address ISO 9001: 2015 Standard
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The document discusses conducting a SWOT analysis and provides guidance on the proper process. It advises determining relevant factors, conducting external research beforehand, defining the scope and timeline, involving key people, and discussing the process with attendees. It also notes the analysis meeting should use tools like whiteboards and post-notes to generate documented outcomes and agreed upon actions. Maintaining and updating the results over a 3-5 year period is also recommended.
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Getting The Contex Right: Using Simple SWOT Analysis to Address ISO 9001: 2015 Standard
- 1. Getting the Context Right SWOT Welcome and Thanks for Attending Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 1
- 2. Colin Gray & Cavendish Scott • Colin Gray – 30 years auditing, training and consulting. – IRCA, EG, PECB Lead Auditor – IRCA Lead Auditor instructor and training designer Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 2 • Cavendish Scott, Inc. – ISO 9001:2015 consulting packages – Training, auditing and gap analysis – 30+ Years Experience – Guaranteed Success – IRCA ISO 9001:2015 Lead Auditor and Transition Training
- 3. Getting the Context Right Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 3
- 4. ISO Requirement • 4 Context of the organization • 4.1 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 quality management system. • The organization shall monitor and review information about these external and internal issues. • NOTE 1 Issues can include positive and negative factors or conditions for consideration. • NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. • NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization. Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 4
- 5. More Thoughts • Where is the requirement for a procedure? • Where is the requirement for a record? • How will it be demonstrated/audited? • WARNING: Huge interrelationships with other requirements. – Purpose and Strategic Direction – Risk and Opportunity – Planning, Objectives – Change Management – Communication, People, Awareness, Interested Parties Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 5
- 6. S.W.O.T Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 6
- 7. SWOT – This Presentation • Strengths – Funny accent – Simple message • Weaknesses – Competing with the “experts” on at the same time – Can be complicated and confusing • Opportunities – Inform and educate – Get people to request me next year on their survey • Threats – Confuse people with too much detail Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 7
- 8. Problems with that • We had no idea what we were supposed to be doing. • We were not sure of the perspective from which we were doing it. • Still not 100% as to what a “strength” is, etc. • Not sure what to leave in and out or the level of detail we were doing it to. Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 8
- 9. Basics of SWOT Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 9
- 10. The Process For SWOT • Determine, agree and document the categories or factors that will be used to break down the four elements. • Conduct external research so that it is ready prior to the SWOT “meeting” • Define the Scope including the timeline or timelines to be used (1 year or 5 year horizon) • Define the People to be involved. • Clarify the purpose of the organization and the strategic direction • Ensure documented information about internal values, mission, goals, etc. • Discuss the and clarify the process for attendees. • Much of this can be completed in advance and provided to attendees before the SWOT “meeting” • There will be documented tools – Agenda, roles, charter, rules, minutes template, records template, approach, tools, steps, investigation and needed inputs, action items template • ? Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 10
- 11. The Process for SWOT • SWOT “meeting” – whiteboard, post-notes, etc. • SWOT or TOWS, • PESTLEE, STEEPLE, ISO, Values, Mission, Vision [internal] • Bring research and other information • Use the tools • Generate records and outcomes • Agree Action Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 11
- 12. Final Thoughts • Forwards or backwards - SWOT or TOWS • Categories or Factors to help identify issues • Prior research and clearly documented information • Defined process with tools • Formal Actions • Maintenance of the results • Ensure the answers cover the future 3-5 years • Colin Gray • colin@cavendishscott.com • www.cavendishscott.com Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 12
Editor's Notes
- Context is one of the most important requirements in the standard. It provides the environment for the planning of the whole system.
- Colin has been working in the industry for many years and focuses on value added solution and the precise interpretation of the standard.
- Context starts with organizational purpose and strategic direction. These should be discussed and documented before considering the context. It is possible to consider purpose, strategy and context from a much broader business perspective. However, the standard requires it only address quality and this is a good place to start. If an organization feels comfortable extending their focus later then that is fine – later. Note that the process here goes beyond identifying the context. Organizations are required to monitor issues which means the data must be maintained. Typically there are two elements to this. The issues should be reviewed “periodically” (often annually) in case something happened that would change things but was not noticed. Also, whenever there is a known planned (or unplanned) change then consideration should be given to whether issues are impacted. These elements must be formally included in the process.
- Like all “requirements” there needs to be a formal process to address this section. And like all processes there should be a procedure (or equivalent) and appropriate controls and tools to ensure it is followed. The process must be designed to provide a valuable benefit to the organization, BUT it should also generate records so that it can be used (e.g. action items) but also such that the process and its effectiveness can be demonstrated to an external auditor. Note the potential complexity here. Change management – needs to interact with Issues. Interested parties change, could affect issues (and vice versa). Processes change – could affect issues. Issues change, risks and opportunities change. There is substantial interaction throughout the organization.
- A quick review of SWOT for this presentation
- A quick review of SWOT for this presentation
- The previous quick SWOT was not effective beach we did not determine a clear perspective. From whose perspective were we doing this. The presenter? The attendees? The Conference organizers? The answers will be different. Definitions of SWOT were not formally established and so confusion could exist over what is a strength and what is not, for instance No clear understanding of the level of detail – we could discuss threats that really don’t manifest if we go to too much detail.
- Internal (SW) and External (OT) Positive (SO) and Negative (WT) Developed as a tool for business. In practice we are limiting it to quality, but the approach is valid. Google it.
- Discuss and agree categories or factors to break down SWOT elements. Note that this will help shape research Conduct research in advance so the SWOT “meeting” is more productive. Define and Document the Scope. What are we going to cover. What time line? If we have a growth strategy, how much growth and when will it be over? What then? We are discussing organizational strategy. We need top management Clarify the purpose of the organization and the strategic direction – make sure they are documented.
- In practice this is a “meeting” or brainstorming session. It can be multiple sessions and could be conducted without an actual meeting e.g. reports, comments, blogs, telephone discussions, Ensure the process is clearly defined and all tools available to make it happen. No confusion. Initial discussions and possibly internal/external interviews need to be conducted beforehand to enable the process to be defined and direction established. Flexibility must exist to allow change of direction, additional research, more interviews etc. if that is the outcome. It may not always be possible to predict everything that comes out of the meeting in advance and prepare. SWOT can be applied forward or backwards TOWS. Some people advocate a reverse approach to change bias. We break the organization into categories or elements that help us consider issues that are important. These categories or factors may lead us to further research and then may identify an issue that can be considered a strength, weakness, opportunity or threat. There are many different options: Functional departments. Sales, Design, Production, etc. and they we ask what are the strengths for that department. We can also use processes (so Document Control and Records Management will be factors to consider) For external issues consider breaking into these categories/factors: PESTLEE Political, economic, social, technological, legal, environmental, ethical STEEPLE Social, technological, economic, environmental, political, legal, ethical These tend to be more applicable for the external issues – Opportunities and Threats. ISO defined some categories/factors in the notes to 4.1. External issues: legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. Internal Issues context: values, culture, knowledge and performance of t Also look to your own mission, vision and values. e.g. Integrity, Ethical Behavior, Innovation, Productivity, etc. While these can be used at categories and factors, they should also be considered to help identify relevant answers (strengtyhs/weaknesses) because they shape the organization. Brainstorm issues Agree additional research Agree actions. Actions are important. Plan what you are going to do with this information – does it feed to risk management, are there opportunities.
- Cavendish Scott has been working with ISO 9001:2015 since the DIS was released in the middle of 2014 We remain on the cutting edge of meaningful management systems while not overlooking the need for conformance to standards to achieve certification. Cavendish Scott offers gap analysis audits to ISO 9001:2015, Project and Document planning solution for ISO 9001:2015, IRCA approved and public and customized Transition and Auditor training, and standardized and open consulting projects for ISO 9001:2015 – as well as AS9100, ISO 13485:2016 and ISO 14001:2015.