1. Catch My Draft? Dissecting the ISO 9001:2015 draft international standard

    March 16, 2015 by ahmed

    originally posted on Quality Progress by R. Dan Reid

    As you probably know, ISO 9001, the fundamental international quality management system (QMS) standard, is being revised. It is at the draft international standard (DIS) stage at the time of this column’s publication and due to be released in September 2015. Figure below shows the revision timeline.

    This article discusses some content in the current draft, but remember that changes still may be forthcoming, so you should not proceed too far with implementation of new content in the standard at this time.

    Vertical alignment
    It’s important to realize not everything in the new version of ISO 9001 is changing. The 2012 global user survey that was conducted to determine whether a revision to ISO 9001 was needed indicated a majority of users believed the standard was acceptable as-is or with slight modification.

    The support for change came largely from within the International Organization for Standardization (ISO) community, when a small task force recommendation to use a new and mandatory clause structure was supported by the ISO technical management board.

    The purpose of this support was to drive standardization among new or revised ISO management system standards, such as those related to quality, the environment, and occupational health and safety. The adopted proposal has been incorporated into the ISO directives, known as Annex SL, and also requires use of some common text under the required clause structure.1

    Some carryover content between the ISO 9001:2008 and ISO/DIS 9001:2015 has to do with the clauses involved in vertical alignment. Many organizations, including those that certify and implement QMSs, do not understand the critical role and linkage of the clauses as intended by the standard writers.

    The first process is to determine customer needs and expectations, which is located in two clauses of the new draft titled, Clause 4.2—Understanding the needs and expectations of interested parties, and Clause 5.1.2—Customer focus. There are three sources of specified requirements for organizations:

    1. Internal (for example, engineering).
    2. External (statutory and regulatory).
    3. External (customers).

    The DIS addresses the external requirements in these clauses, which are then input for the quality policy. There are requirements for top management related to the quality policy in ISO 9001—one of which necessitates a commitment to meet applicable specified requirements.

    W. Edwards Deming said management commitment to quality is insufficient without its also knowing what must be done to achieve quality. With ISO 9001 being the minimum set of requirements for a functional QMS, the QMS does not go that far. Without an effective process to determine customer requirements—the quality policy—effectiveness of the QMS is compromised. The quality policy is intended to drive conformance with specified requirements, as well as drive continual improvement of the QMS.

    Note that in ISO 9001, continual improvement of products and services is not required because it would be difficult—if not impossible—for regulated industries to meet that requirement under the current regulatory environment. Continuing suitability of the quality policy is to be reviewed in formal management review meetings.

    Objectives
    Quality objectives are to be established and to be consistent with the quality policy. The DIS defines an objective as a result to be achieved. Objectives start at the enterprise level to address the external specified requirements, such as regulatory and customer-related ones. There are generally five to 10 high-level objectives.

    More detailed objectives, however, are to be deployed to relevant levels and functions within the organization to support the enterprise-level objectives, which are meant to drive conformance with requirements. Objectives are required to be relevant to product and service conformity and to the enhancement of customer satisfaction, and they must be measurable.

    Objectives are part of planning the QMS, but after objectives are met, they should be revised to drive continual improvement. The need for adjustment of the objectives also should be evaluated in the management review process. The current standard lists the clauses in this order, but the revised draft lists objectives after planning, which arguably does not make as much sense. The process for setting objectives and flowing them to relevant levels and functions in the organization is a key driver of continual improvement in the standard. Organizations that do not use objectives in this manner are missing key value in the QMS implementation.

    Planning
    Objectives are meaningless without plans to achieve them. Plans must list who is going to do what and at what time in the project or process, the required resources and how progress will be measured along the way. Resource determination should be made using data, taking into consideration workload on existing employees, budget and resource availability.

    Risks also must be considered in developing plans to ensure they are adequately prevented or mitigated by the QMS. Use of risk identification and quantification tools is recommended to appropriately prioritize efforts, based on data. Emphasis should be on error-proofing processes to prevent problems from occurring because detection is not as effective as it should be.

    Plans should be reviewed for adequacy prior to release. Plans are developed with some expected end in mind. Ask: Does that end go far enough to meet specified requirements and drive continual improvement? Sometimes, it is known up front that the plans are not adequate to achieve the objectives. When this is the case, management should approve and consider revising the objectives.

    Note that the clause on preventive action in the current ISO 9001 standard is not included in the draft revision. It was associated with the current corrective action clause, which is not truly an effective planning function. Current thinking is that planning the QMS up front is the best preventive action, making a clause linked to corrective action unnecessary.

    Metrics
    After sufficient plans are in place, metrics are needed to monitor progress in achieving the objectives and specified requirements. Just as objectives are set at the enterprise level and deployed to relevant levels and functions in the organization, so must the metrics be set. They must be in place at relevant functions and levels, and for products and processes that can affect quality or delivery. There should be leading, contemporaneous and lagging indicators to adequately monitor the progress of plans being carried out across the organization.

    Data for control charts in high-volume production processes are collected in real time, but a control chart can forecast future process performance if the process is statistically stable. If you have enough data and the process is stable, you can also accurately predict nonproduction process performance, such as achievement of annual cost savings. Lagging indicators, such as those about warranty issues and customer satisfaction, are also important to monitor and react to when necessary.

    With regard to customer satisfaction, many organizations track metrics that are actually indicators of customer dissatisfaction, such as complaints, returns and parts per million (ppm) defects. The assumption is that if these metrics show low occurrence, customer satisfaction is achieved, but this is not necessarily so.

    Your product or service performance may not be bad enough to cause a customer complaint, return or high ppm, but the danger is that a competitor may be satisfying and delighting customers, and your organization would not be able to detect this if it is tracking only customer dissatisfaction metrics.

    Looking at the ISO 9001 DIS, many of the core concepts remain unchanged from the current standard. The changes that are being proposed provide an opportunity to implement the existing requirements more effectively to add value to the organization and not just implement a QMS because customers require it.


  2. Integrated Management Systems: Unleashing the power of ‘ONE’

    March 13, 2015 by ahmed

    Originally posted on LinkedIn by Sithandilizwe Sly Malunga

    PART I: What is the Integrated Management System (IMS)?

    Introduction

    In addition to delivering profits for their shareholders, companies around the world are increasingly being required to conform and comply with statutory, regulatory and other requirements in order to stay in business.

    Statutory requirements compel organisations to comply with local and national legislature e.g. Acts of Parliament, Local Authority By-Laws and related regulations in the regions or countries within which they operate.

    Other requirements include but not limited to industry codes and regulations such as UK Corporate Governance Code (United Kingdom), King Code of Corporate Governance (South Africa); national and international standards such as ISO 9001 Quality Management System, ISO 14001 Environmental Management System, OHSAS 18001 Occupational Health and Safety Assessment Series etc.; national and international accounting standards and international treaties and protocols such as those emanating from regional and international groupings such as the Common Market for Eastern and Southern Africa (COMESA), European Union (EU), United Nations (UN).

    In practise, an organisation will invest vast amounts of money, time and human capital in order to implement systems that will enable them to comply or conform with the diverse requirements stipulated upon them. Implementing a singular set of requirements can be simple and straightforward and with prudent project management costs are manageable. However, it can becomes complex when an organisation has to implement and comply with two or different more sets of requirements. It usually means two separate projects running concurrently which may result in exorbitant project costs as the projects are managed and funded separately; more time is needed for audits; awareness sessions and other processes related to implementation and maintenance as these should be done separately. As such some organisations particularly regional and global transnational conglomerates are increasingly exploring and leaning towards the implementation of integrated management systems in order to optimise on resource usage during the implementation and maintenance of statutory, regulatory and other requirements as discussed above.

    Scope

    The scope of this article will be limited to the integration of ISO standards/management systems in particular:

    • ISO 9001- Quality Management System- Requirements;
    • ISO 14001- Environmental management systems – Requirements with guidance for use;
    • OHSAS 18001- Occupational health and safety management systems – Requirements;
    • ISO 31000- Risk Management -Principles and guidelines;
    • ISO22301-Societal security – Business continuity management systems – Requirements;
    • ISO 50001- Energy management systems – Requirements with guidance for use;
    • ISO 27000- Information technology – Security techniques – Information security management systems – Requirements ;
    • ISO 26000- Guidance on social responsibility; and
    • ISO 22000- Food safety management systems – Requirements for any organization in the food chain.
    • In addition, the article will attempt to show how other requirements, tools and techniques such as the Lean Six Sigma methodology, King Code of Corporate Governance, UK Corporate Governance Code, national and local legislation etc. can be blended into an IMS to drive continual improvement and enhance the effectiveness of compliance controls.

    Definition

    An “Integrated Management System (IMS) is a management system that integrates all of an organisation’s systems and processes in to one complete framework, enabling an organisation to function as a single unit with integrated goals and objectives.”

    An integrated management system (IMS) integrates several related processes of an organisation into a single system for simpler implementation, management and maintenance. Most commonly incorporated into an IMS are ISO 9001 – Quality Management System), ISO 14001-Environmental Management System, and Occupational Health & Safety management systems. The approach is not just to link these management systems discretely, but to identify similar requirements and processes and establish how they interact so that they are seamlessly integrated, managed and executed without replication. The IMS model allows for resources common to all the systems to be pooled together and used optimally for the implementation and maintenance of management systems

    Drivers for implementation

    Organisations will have different reasons to implement management systems in their operations. Common drivers for implementation are wide-ranging and can be classified into four categories namely Enterprise, People, Market and Corporate citizenship. These drivers include but not limited to the following:

    In addition, the figure below depicts how different management systems can be applied to specific areas or objectives of an organisation with a view to positively impact stakeholder value.

    Benefits of implementing an IMS

    The implementation and maintenance of an IMS within an organisation has several benefits. Some of these are listed below:

    • Enhanced compliance and conformity to statutory, regulatory and other requirements;
    • Savings in cost and time as review meetings, audits, procedures for different management system are integrated.
    • Improved competitive advantage;
    • Increased customer satisfaction;
    • Improved profitability and shareholder value;
    • Fostering cross functional teamwork ( No more silos)
    • Business objectives and targets becomes more understandable across all levels of the organisation;
    • Effective cross-functional problem solving;
    • Communication, consultation and participation within the organisation is improved;
    • Duplication of processes, procedures and efforts is eliminated; and
    • Incorporation of additional compliance and conformity requirements is easier to implement and manage going forward.
    • This article will run over six parts with one part published on a weekly basis for the next six weeks.

    Part II will cover the implementation of IMS with a focus on process-based and risk –based implementation methodologies. This second part of the article will also explore the different approaches to implementation within an enterprise taking into consideration organisational culture, size of enterprise, nature of risks to which the organisation is exposed to and cost efficiency among other factors.

    For Part II of the article please click the link below:
    http://www.linkedin.com/pulse/integrated-management-systems-unleashing-power-one-part-malunga

    For Part III of the article please click the link below:
    http://www.linkedin.com/pulse/integrated-management-systems-unleashing-power-one-part-malunga-5974818069741133824?trk=prof-post


  3. Managing Resistance to Improvement

    February 26, 2015 by ahmed

    Originally posted on LinkedIn by John Schultz

    Why Improvements Can Produce Anxiety

    Systems and processes exist in their current state because someone got them to that level of refinement. Flawed and inconsistent as these practices may now appear, at some point in the past, an effort—possibly heroic—was made to coordinate activities and relationships to create a sense of order.

    Then over time those involved learned to compensate for gaps and made the system operational. In turn, these employees built a mental model about who they were and what they could do based on this arrangement for getting work done. Proposed improvements often threaten these mental pictures and create self-doubt because the new way of operating will require skills and social structures that are not familiar. The thought of uncertainty then produce anxious feelings about loss of identity, loss of position, and loss of face that give rise to guarded behavior.

    These fears may take many forms from negative attitudes to active sabotage, and may become evident through reduced productivity, decreased quality, increased absenteeism, and produce increased grievances. The following are typical sources for anxiety:

    • Comfort with current operations: The old way for getting work done has been in place for some period of time, and seems to be working fine. Process operators and stakeholders don’t see a need to “reinvent the wheel.”
    • Doubt about the need and vision for improvement: There is uncertainty about the reason behind proposed improvements and how existing work structures and relationships will be impacted. The question—“what’s in it for me?”—has not been adequately answered.
    • Concern over loss: There is a perceived fear over how improvements will affect acquired skills, salary, status, quality of work, or other benefits attributed to the existing process.
    • Organization’s past history: Past proposals for improvement have been poorly handled—muddled implementation, lack of resources, inadequate training, or the eventual abandonment of activities—only to have remedies replaced by another “program of the month.”
    • The proposed improvement is flawed: There is a realization that the new way for operating has real problems that will ultimately create difficulty in the current or adjacent processes.

    Helping People Deal with Concerns over Improvement

    People confronted by altered circumstances frequently experience grief and will go through a distinct conversion process before taking on their new roles. The length of time at each stage varies depending on the situation, the type of support provided, and individual adaptability. Each step has its own set of recognizable characteristics. Accepting and understanding these stages will provide an opportunity for the project team—as agents of improvement—to reduce resistance and move system improvements forward.

    The following is an adaptation of Lynn Fossum’s thinking on behavior patterns people will go through upon encountering situation-altering events. This process is based on studies done by Elizabeth Kübler-Ross, who primarily worked with people confronted by mortality. However, she also observed that similar behaviors occurred for people wrestling with other types of loss.

    • Indifference: A belief that a proposed change will make little difference and nothing new is really going to take place. Or when it does, individual interests will be taken care of. As a result, work continues as usual.
    • Opposition: There is a realization that the old way of doing things will not work, and new rules apply. There is an active pushback to maintain old and familiar routines.
    • Consideration: A recognition that changes are starting to affect people’s work. Adaptations are required to reduce confusion. By modifying and tailoring work processes, some things begin to function better.
    • Cooperation: The new process begins to exhibit some successes. Workgroups can see results. The skeptics and cynics are proven wrong and leave or buy in.

    Although the urge to push new ideas upon a process without reflection can be tempting, doing so often works to undercut the improvement effort. Modifications that plan for and manage human relations concerns with the same attention as practical matters have a much better chance of being accepted. People experiencing change are less likely to feel intimidated when they can understand and anticipate how alterations may impact their work and ability to contribute. A pragmatic approach is generally viewed as less daunting and more acceptable. To be successful, improvement activities should include practices that reduce resistance and anchor the proposed improvement so others are not confronted with the same problem at some point later on.

    The resulting dilemma, therefore, when making improvements is not the technical aspects of change, but dealing with the human behavioral issues that are inevitably encountered. By not taking the time to consider stakeholder needs and circumstances, a well-crafted solution can fail to gain traction while process operators and supervisors come to grips with new and unfamiliar concepts. People who work in and manage the process then become grousing skeptics, procrastinators, and even active resistors. Due to frustration, improvements are half-heartedly accepted without creating a sense of ownership and a lasting impact.

    Groups affected by change need to be part of the decision-making and allowed to work their way through developments. The inclusion of workgroups can consume valuable time and create frustration for change agents; nevertheless, people will almost certainly not modify attitudes and behaviors because they were told, pushed or warned. Being an agent for change has contingencies, and one of them is followers. In most organizational and social-political settings people have options. They can quit, go on strike, reduce their output, protest and sabotage directives, or engage in a campaign to overthrow the status quo and gain control. Ultimately, change needs to be more than a spectator pursuit.

    Techniques for Dealing with Resistance to Improvements

    Fear and anxiety are a natural response to change, but they can be dealt with. However, this requires an atmosphere of openness where people can speak their mind and be listened to. The key to coping with resistance is to understand those affected by reforms and then actively take steps to address their issues.

    When there is abnormal resistance to a proposed improvement, it should be a signal that something may have been missed. Mistakes may have been made, concerns may not have been satisfactorily handled, or the proposal may not have been adequately presented and thus may have been misunderstood. The choice of responses and techniques that might be applied are multiple and somewhat dependent on the personal perspective of the individuals involved and the challenges encountered.

    The following strategies adapted from John Kotter and Leonard Schlesinger (1979) are methods for dealing with resistance to change. Any or all may be used depending on the situation. Each technique has situational uses and produces consequences that can have both favorable and unfavorable outcomes:

    • Two-way communication: Used when there is the assumption that information is lacking, inaccurate or being poorly analyzed. Involves listening to employee concerns and providing precise information.
    • Group participation and decision making: Ensures that those affected by the change have input into the design and realization activities. Employee groups take an active role in the implementation process.
    • Education and training: Special attention is paid to people’s needs and concerns through team building, confidence building and training to ensure skills are sufficient for alterations in responsibility.
    • Negotiation and bargaining: Through a process of open discussion, modifications are made to proposed changes. The rate of implementation and issues dealing with employee welfare are usually negotiated.
    • Economic incentives: Some form of compensation is provided to reduce losses that result from the change. Guarantees against the loss of wages and commissions also may be used in this case.

    Unfortunately, the pressure to get something done and move on often leads to transformational approaches that do not produce buy-in, but instead promote compliance in a situation in which continuing relations between levels of authority can become adversarial. Although expedient, such actions can destroy trust, undermine future relationships, create a strong feeling of loss and set the stage for whistle blowing and sabotage.


  4. South African Quality Institutes latest news

    February 18, 2015 by ahmed

    South African Quality Institute (SAQI) http://www.saqi.co.za is the national body that co-ordinates the Quality effort in South Africa. Their monthly newsletter is an excellent source of information to keep up with the latest quality issues in South Africa.

    SAQI201410

    • Why Advanced Product Quality Planning (APQP)?, by Jacques Snyders
    • An Evening with Jack Ma, by Ir. Dr. Lotto LAI
    • Transition Planning Guidance for ISO 9001:2015
    • Directors Balancing the Assets: ISO 55000, by Terrance M. Booysen
    • Being an introvert is absolutely OK!, Dr Richard Hayward

    Click here to download download this newsletter.

     

     

     

     

     

     

     


  5. The Art of Root Cause Analysis

    February 9, 2015 by ahmed

    Originally posted on Quality Progress by Vidyasagar A

    Root cause analysis reminds me of the intriguing mind of a child: Both use common questions that start with “what,” “how” or “why” in an attempt to understand something and uncover answers.

    Children often satisfy their curiosity as they ask questions to better understand their environment. You could say that they’re already unknowingly using a simple, yet essential quality tool-five whys analysis-to clarify their own questions and get to the truth.

    If five whys analysis is used in science to achieve a clear objective, the tool can be just as powerful in the business world as it is for children exploring their own surroundings. As a practicing Master Back Belt, I often use this technique to successfully arrive at the root causes of problems.

    What’s five whys analysis?
    Five whys analysis is the art of systematically drilling down to a real root cause (see Figure 1). It’s a simple, yet effective way to determine the root causes in almost any situation. Essentially, you can find the root cause of a problem and show the relationship of causes by repeatedly asking the question, “Why?”

    Does this remind you of the lean tool TRIZ, or the theory of inventive problem solving? It should, because they can complement each other well.

    Online Figure 1 shows a simple example of five whys analysis of “Getting caught speeding on the road.” This particular example captures just one answer for every why question asked. Typically, you would have more than one answer for every why question, and each one could be subjected to another why question

    analysis01

    Applying five whys analysis
    You could say five whys analysis is the art of asking the right question at the right time. In Online Figure 1, it’s important not to skip levels of questions or hurry through them to reach a perceived root cause. You must approach this analysis step by step with logical questions summarizing the observations from earlier questions.

    analysis02

    Don’t get too caught up with asking five questions. Sometimes, it may take just three why questions to reach the root cause. Other times, it might take many more. Once, I had to ask 14 whys to reach a root cause. As you master the art of questioning, you will arrive at the root cause much more quickly.

    Things to remember
    It’s important not to leave any loose ends. Each loose end must be tied up with a fresh why question, or it should become part of another question being asked.

    Another critical point in this analysis is knowing when to stop asking why. Some experienced practitioners say that you have reached the true root cause when the answer to your why question is a process, policy or a person. Often, these answers turn out to be the real root causes.

    Knowing when to stop mostly depends on three questions:

    1. How relevant are the questions and answers to the original X or Y you are investigating?
    2. Did you find a root cause that helps you control or avoid the situation?
    3. Are the questions and answers significant enough, considering your project scope?

    The real problem
    When and where to stop questioning why is the most important part of this approach: Do not stop unless you reach a process, policy or a person that seems to be a root cause. Often, there can be many root causes with a compounding impact placed at different stages of the five whys drill-down.

    It is also important to recognize that the real problem in a Six Sigma project is not that we don’t know the solutions. The real problem is that we don’t know real root causes.

    Often, some X’s might not have further data to further drill down using Six Sigma tools. Hence, using five whys analysis is almost essential in Six Sigma implementation. Correctly using this technique can be a big differentiator for the project.