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Monday, January 11, 2016
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ISO Standards and Industry Resources

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    Top 5 Tips for Effective Procedures

    The ISO 9001 quality management system requires for organizations to write different procedures to prevent non-conformances and to guaranty that specific jobs and processes are carried out correctly.

    When writing these effective procedures it is essential to take the following into account:

    1. Identify what type of procedure or document needs to be developed.

     

    Different documents are essential in the QMS and each type of procedure or document has a specific role and objective. Some of the most commonly used documents in an ISO 9001 QMS are:

    • Manuals: define the general aspects of business management (Quality Management Manual).
    • Operating Procedures: Explain how an activity or process unfolds. Usually the most common documents.
    • Technical notes and instructions: further develop the content of an activity. They are mainly focused on fieldwork.
    • Guides: These are similar to the procedures and technical notes, but with the proviso that they are not binding guidance.

    2. Know in detail the structure of a procedure or document.

    Organizations need to define a structure and a standard way to write these effective procedures in order to guaranty that they are written in a consistent manner. Knowing the structure will facilitate the process of gathering the essential information necessary to write an effective procedure.

    The structure may vary from organization to organization; however, a structure that many organizations use is provided below:

    • Home: the first page of the procedure usually includes the title, code, date of writing, version number (or revision), table of contents, total number of pages, name and signatures of the persons who have prepared, reviewed and approved it.
    • Purpose and Scope: Describes a summary of the purpose and content of the procedure.
    • References: documents that have influenced the development of the procedure are listed.
    • Definitions: technical words that are used in the content of the procedure.
    • Responsibilities: list of individuals or departments responsible for carrying out the activities described in the procedure.
    • Development (or description): describe in detail the activity performed.
    • Annexes: everything that is considered important but that takes up too much space to include it in the description section (tables, drawings, diagrams).

    3. Review the document with the people that will use it.

    In order for a procedure or any document to be effective, it must be understood by the people who will ultimately use it. That’s why it is important for these people to review the document at different stages of its development. Effective procedures have been reviewed directly by the people who will be using it the most.

    4. Consider different people’s views and perspectives.

    A procedure should not be developed with the view or information of just one person. Most processes or activities that need to be document could be complex and having different perspectives can enrich the procedure. Effective procedures will multiple views into account.

     

    5. Make it simple.

    Procedures should not be difficult to read. On the contrary, they must be clear and concise. Sentences must be as short as possible to make sure that it is comprehensive and easy to read. If procedures are never read or understood by the intended audience, they are not likely to serve as an effective tool in any process. Effective procedures need to be readable by everyone involved in the process.

     

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      ISO 9001 and ISO 9004 are standards that complement each other and their implementation aims to ensure quality success and reach improved performance in any organization. Both these standards can be implemented independently or simultaneously; however, the most common scenario is for organizations to implement ISO 9001 and later use ISO 9004 to improve their processes and to obtain long term benefit from a more broad-based Quality Management System.

      These standards are both similar in terms of structure and terminology used to allow easy integration. They are also based on the same quality management principles, therefore, when an organization has successfully implemented ISO 9001, it is relatively simple to integrate ISO 9004 and achieve an improved performance.

      The best way to integrate these complementary standards is by doing the following:

      Organizations need to identify and rank their quality needs, where the most basic needs are at the bottom and address ISO 9001 requirements and at the top are the needs to achieve improved performance. After identifying and ranking these needs, organizations must work up from ISO 9001 to ISO 9004 one step at a time.

      Effectiveness

      One of the basic needs that should be addressed is the effectiveness of the quality management system, that include areas such as

      1. meeting customer requirements;
      2. prevention of customer dissatisfaction;
      3. recalls and defects; and
      4. the production of safe products.

      Efficiency

      After meeting the effectiveness of the system, the efficiency should be then addressed. Here the focus should be

      1. the efficient use of resources;
      2. the reduction of material costs;
      3. the decrease of cycle times; and
      4. the increase of the organizations productivity.

      Competitive Advantage

      Achieving competitive advantage should be the last need to address; here it is essential to focus on ensuring delighted customers, increasing market share and increasing profitability.

      This process is continuous, because an organization may never relegate it’s basic needs to address its top ones. It must constantly work in meeting all of them and ISO 9004 gives guidance on how to achieve this continuous improved performance.

      Before attempting to integrate ISO 9001 and ISO 9004, it is essential to fully understand them both; even though they complement each other, they have different roles and different approaches. They each have a role to play in providing value to any organization that decides to embrace them both to improve their quality management system and achieve long term success.

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        Here are five key elements that will help organizations reach a successful ISO 14001 Environmental Management System (EMS):

        1. Employee Involvement

        The first key element for having a successful EMS is to achieve full participation of all employees, from top management to shop-floor workers. If people are not involved, every goal and target will require a lot more time and effort to be reached. Many believe that only a small group of people in an organization are responsible for the EMS but nothing is farther from the truth; the whole organization is responsible for the implementation, maintenance and improvement of the EMS.

        2. Regulatory Compliance

        One of the main objectives of an ISO 14001 EMS is for organizations to obtain regulatory compliance. Organizations need to use the EMS as a tool to effectively define and monitor applicable legal requirements and other requirements. By using the EMS as a tool for assuring regulatory compliance, an organization can better plan the expenses associated with permits, reporting and monitoring legal requirements, which will reduce the frequency and severity of violations and their associated costs.

        3. Higher Efficiency

        Organizations need to focus on improving the efficiency of their processes and not just on controlling environmental aspects after they have been generated. It’s essential to control and prevent contamination, but an ISO 14001 EMS needs to go beyond this point and focus on improving processes. For example, a higher level of administrative efficiency may reduce legal liabilities and shorter permitting procedures due to better relations with regulators and communities. A greater operational efficiency usually involves renewal of equipment or facilities, and an improved design of production processes that will result in a reduction of inputs (energy, water and other resources) and also a reduction of waste.

        4. Using the Right Performance Indicators

        Every organization is different and so are their environmental aspects and impacts. It is essential to define and use the performance indicators that will allow organizations to effectively monitor their performance and identify opportunities for improvement.

        5. Improving Customer Relations

        Organizations need to establish relationships based on trust and respect with regulatory bodies, communities and everyone that may affect their EMS. Good relationships with internal and external customers will contribute in the success of the ISO 14001 EMS.

        It is important to remember that every EMS is different and a continuous monitoring process is essential in determining the organization’s progress in meeting its goals and objectives.

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          Auditor Training

          Internal Auditors require theoretical and practical auditor training. Usually, when organizations train a group of internal auditors, the theoretical training is done by an outside organization.

          This formal auditor training will have to consist of the following:

          • Audit principles
          • Objectives of an audit.
          • Types of audits.
          • Benefits of implementing internal audits.
          • Different auditing approaches.
          • Competences of an auditor.
          • Responsibilities of an auditor.
          • How to prepare for the audit: Establishing the audit program, defining the elements of the management system to be audited, preparation of checklists, selecting the audit team.
          • How to conduct an audit: How to contact the auditee, developing the audit plan, carrying out the opening meeting, how to gather evidences, defining findings, conducting the closing meeting.
          • Reports and Follow-up: Categorization of findings, preparing the report, approval and distribution of the report, monitoring.
          • Competence and evaluation of auditors: General, personal attributes, knowledge and skills, training and work experience, maintenance and enhancement of skills, auditor evaluation.

          In addition to this basic auditor training regarding the skills, knowledge and competences of auditors and how to prepare, conduct and monitor audits, it is essential for internal auditors to fully know and understand the standard that they will be auditing against. Here an additional training session will be required. The most frequent standards that organizations use that require the execution of internal audits are ISO 9001, ISO 14001 and OHSAS 18001; however, the standards use will depend on the needs and objectives of each organization.

          After an auditor has received this theoretical auditor training, they can now begin their practical training by participating in an internal audit. This practical auditor training usually is done following these steps:

          1. Participate in at least 2 audits as an observer or auditor in training. Here they usually participate in the planning stage of the audit but when the audit is being conducted they only observe; they do not take any actions in any of the activities during the audit.
          2. Participate in at least 2 internal audits with supervision of a lead auditor. Here they take a more active role in the preparation and in the conducting of the audit.
          3. After having successfully carried out a number of internal audits and having sufficient skills, knowledge and experience as an internal auditor, he or she may start to conduct audits as an internal auditor leader. This leader takes full action in all of the stages of the audit.

          The above explanation is how internal auditors are usually trained; however, each organization may decide which way to train their auditors is best for them. What is important is for auditors to receive a constant and progressive auditor training that allows them to acquired the necessary skills and knowledge to conduct objective and impartial audits that meet the objectives for which they audits are carried out for.

          Looking for auditor training? Check our listing to see what’s available near you.

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            One of the main objectives of an ISO 9001 management system is “continuous improvement”; however, the standard ISO 9001 provides little information on how organizations can reach and maintain it. In this specific aspect is where a lean system will provide the biggest benefit to any quality management system. Lean systems require the implementation of different methodologies that will provide organization with the tools to continuously improve their processes and systems.

            Lean manufacturing is characterized for aiming to reduce all the unnecessary in order to use a minimum amount of resources in every aspect of a system, especially on: human effort, manufacturing and storage space, and time.

            This tool helps to eliminate all operations that do not add value to products, services and processes, increasing the value of each action and eliminating what is not required. By reducing waste and improving processes, lean manufacturing gives organizations the tool to survive in a global market that demands higher quality, faster delivery and an increase on customer satisfaction.

            Some of the most common methodologies used in a lean system are 5S, Value Stream Mapping (VSM), Kanban, Key Performance Indicators (KPI), Shadow boards, Poka-yoke and many others. The implementation of these methodologies can bring many benefits to an ISO 9001 quality management system, such as:

            • Reduction in production costs.
            • Inventory reduction.
            • Reduction on delivery time (lead time).
            • Improved quality.
            • Decrease in labor.
            • Greater  equipment efficiency.
            • Waste reduction.
            • Reduction of overproduction.
            • Decrease on delays.
            • More efficient transport.

            The requirements of ISO 9001 have many common aspects with lean production systems, especially in its design and mode of operation, suggesting a high potential for integration.

            The integration of both systems will facilitate the implementation of a continuous improvement philosophy based on a systematic elimination of all types of waste, the respect and consideration of all employees and the continuous improvement of productivity and quality. This will enable organizations to reduce costs, improve processes and eliminate waste in order to increase customer satisfaction.

            Furthermore, lean systems requires the ability to manage raw materials and components in small batches, which requires supply policies based on stable relationships with suppliers.

            There are many organizations that are considering to integrate a lean system into their ISO 9001 management system. This is being done in a pursue to identify and reduce waste from their processes, reach an overall process that flows smoothly and ensure that the organization’s resources are effectively used to meet or exceed customer satisfaction.

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              This is a guest post from Michael Haile from ISO Quality Services Ltd, an independent organisation that specializes in the implementation, certification, training and continued auditing of ISO and BS EN Management Standards.

              Our lead assessors have countless years of experience in helping organisations to achieve ISO Certification. No matter the industry, they have worked tirelessly alongside our clients to aid the growth of their business. Whether it’s a charity, manufacturer or translation company, they have seen numerous successes.

              That being said, there is one issue that is actually very common in our industry and that is the perception of ISO Certification as a necessity rather than an aid. Some organisations, (whether they are aware of it or not) put the ISO Certification in one ‘box’ while putting their business in another.

              Many articles have been written which make a point of explaining the benefits and the importance of management buy-in with regards to certification. These are great and they are very important topics to highlight but sometimes people appreciate practical examples.

              The Myths of Non-Conformances

              One key example that our assessors highlight is that of non-conformances. A non-conformance is something that has happened which should not have happened. From experience the following are the most common misconceptions surrounding non-conformances:

              • Their recording is felt to be adding to their workload
              • Some employees feel like they are ‘telling tales’ on their colleagues
              • Or it is seen as a weakness

              The concern that the recording of non-conformances adds to current workloads is very common and we have a simple mantra which will hopefully ease this:

              “If a non-conformance takes longer to record than to rectify, it is not a non-conformance”

              We have in fact suggested to clients that they change their name to ‘Opportunities for Improvements’. Secondly, recording non-conformances and acting upon them enable organisations to have the ability to make significant improvements. After all, if everybody’s jobs can be made that little bit easier, why wouldn’t you?

              In some circumstances employees are reluctant to highlight non-conformances as they see them as a weakness that can give management a reason to criticize. This should not be the case and one way this can be remedied is by management taking the lead and demonstrating that they too are recording non-conformances.

              Don’t Forget Communication!

              One of the main reasons why there are issues with the non-conformance processes and procedures, or any change within the workplace for that matter, is communication.

              Internal communication in the form of departmental meetings for example is important to get ‘buy-in’ from all areas of the business. If everyone understands why change is happening, how it will impact positively upon their job and how they can help then this will help with employee buy-in.

              Taking the time to explain why change is needed and creating a sense of inclusion makes everyone feel appreciated.

              The Bottom Line

              The bottom line is that the ISO Standards provide a flexible framework that run parallel to an organisation instead of being a separate entity. Furthermore, when embraced and fully integrated, they are able to enhance business performance and make everyone’s job that little bit easier.

              This is a guest post from Michael Haile from ISO Quality Services Ltd, an independent organisation that specializes in the implementation, certification, training and continued auditing of ISO and BS EN Management Standards.

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                Environmental Performance Indicators provide organizations with a tool for measuring, evaluating and controlling their performance. These quantifiable metrics reflect the performance of an organization in the context of achieving its environmental goals and objectives.

                They are also useful in illustrating environmental improvements, identifying market opportunities, providing essential data for environmental reports and statements, providing feedback to motivate members of the organization and to support the implementation of the ISO 14001 standard.

                However, not all performance indicators are useful to every organization. These must be identified and measured considering the nature and context of the organization and its specific targets and goals.

                Even though there’s not a set of performance indicators that is right for every ISO 14001 management system, there are performance indicators that can be commonly seen in many environmental performance indicator reports. Some of these are:

                Operational Performance Indicators

                These measure environmental impact caused by an organization’s main activities.

                Emissions to air

                • Greenhouse Gases
                • Acid Rain
                • Eutrophication and Smog Precursors
                • Dust and Particles
                • Ozone Depleting Substances
                • Volatile Organic Compounds
                • Metal emissions to air Emissions to water
                • Nutrients and Organic Pollutants
                • Metal emissions to water

                Emissions to land

                • Pesticides and Fertilisers
                • Metal emissions to land
                • Acids and Organic Pollutants
                • Waste (Landfill, Incinerated and Recycled)
                • Radioactive Waste

                Resource use

                • Water Use and Abstraction
                • Energy use (Natural Gas, Oil, Coal, other)
                • Minerals
                • Aggregates
                • Forestry

                Environmental Management Performance Indicators

                These reflect organizational actions management is taking to minimize their environmental impact. These indicators serve as internal control measures and information, but do not provide valid information on the real environmental performance of an organization. These performance indicators should not be used exclusively for the evaluation of environmental performance, but as a support in evaluating the actions taken within the environmental management system. Some of these are:

                • Number of sites that have environmental management systems
                • Number of ISO14001 certification
                • Number of training sessions regarding environmental preservation and of people attended
                • Number of environmental audits by kinds (internal and external environmental audits)

                Every organization is different and each one needs to carefully examine which environmental performance indicator suits it best. These indicators should summarize extensive environmental data to a limited number of significant key information points and ensure rapid assessment of the organization’s main improvements and weaknesses in environmental protection. This information should be comparable from year to year or period to period, allowing unfavorable trends to be quickly detected in order for timely actions to be taken to correct and improve the organisation’s environmental performance.

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                  measuring safety

                  Performance indicators for an Occupational Health and Safety (OH&S) management system are an important tool used by organizations to measure the effectiveness of their programs in reducing potential and actual OH&S risks. These performance indicators also provide information for organizations to:

                  • Evaluate their OH&S management system.
                  • Identify improvement opportunities.
                  • Adapt objectives, goals and strategies.
                  • Raise awareness among decision-makers and everyone in an organization about the benefits of OH&S programs.
                  • Take timely preventive measures.
                  • Communicate ideas, thoughts and values.

                  Performance indicators should be specific, easy to obtain, consistent over time, accurate and transparent in order to serve as a valuable tool in improving an organization’s OH&S performance. There are no fixed performance indicators that must be used by all organizations; however, below, a number of typical performance indicators of an OHSAS 18001 management system are mentioned.

                  Performance indicators for OHSAS 18001 communication and leadership management:

                  • Percentage of management planned visits to the job site carried out on a specific time frame.
                  • Degree of management commitment, measured through surveys in the workplace.
                  • Percentage of planned formal reviews of the OH&S management system programs conducted over a period of time.
                  • The percentage of training activities carried out vs. those that were planned.
                  • The percentage of investigations of accidents / incidents / nonconformities completed vs. those that were required.

                  Performance indicators for measurements of the effects of accidental losses:

                  • Number of accidents.
                  • Number of days lost to illness.
                  • Number of days lost due to accidents.
                  • Percentage of workers with occupational diseases.

                  Performance indicators for basic and immediate causes of accidents:

                  • Percentage of accidents caused by getting trapped.
                  • Percentage of accidents caused by strokes.
                  • Percentage of accidents caused by cuts.
                  • Percentage of accidents caused by falls.

                  Performance indicators for OH&S resources management:

                  • Level of funding provided to the OH&S programs as a percentage of operational funding.
                  • Percentage of purchase orders with specific OH&S requirements.
                  • OH&S approved budget against the actual budget spent.

                  Every organization is different and each should take the necessary time to define the performance indicators that will serve as tools in improving their OH&S management system; ones that will help management make sound decisions to maintain, improve and innovate their processes and keep their workers and everyone involved in their activities safe.

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                    ISO 20000

                    Every organization is different and even though an ISO 9001 Quality Management System (QMS) is directed to achieve and increase customer satisfaction, its design and implementation is influenced by the different needs and objectives of an organization.

                    In order to meet and improve customer satisfaction it’s essential to monitor and measure performance by using different indicators. Performance indicators are tools used for determining how and to what degree an organization is meeting guidelines, policies, objectives, requirements and targets set in their ISO 9001 QMS.

                    These performance indicators are set by the organization and they vary from one organization to another. Each organization must decide which performance indicators are more suitable to the nature of their industry sector and their objectives.

                    What should be considered is that these indicators must be measurable and achievable. They must refer to the system’s critical processes, they must accurately represent the target to be measured, and they should be quantifiable, cost-effective, reliable and allow management to know the information in real time.

                    Below, the critical areas to be measured and some examples of indicators are mentioned.

                    Cost Indicators

                    These are performance indicators that evaluate the activities that consume economic resources in different processes.

                    • Percentage costs spent on energy consumption.
                    • Percentage return on investment.
                    • Percentage cost of carrying out reworking or correcting errors.

                    Time Indicators

                    These performance indicators measure the time consumed in an activity or process and considers the time from the beginning to the end of the selected process or activity. For example:

                    • Percentage number of products or services delivered on time.
                    • Percentage number of products or services delivered late.

                    Productivity Indicators

                    These performance indicators measure the efficiency of resources in the operation. Some of these could be:

                    • Percentage machine/equipment utilization.
                    • Percentage of downtime.

                    Quality Indicators

                    These performance indicators calculate the effectiveness in the development of activities or processes, delivering results based on the number of errors, number of perfect and flawless deliveries. An example is:

                    • Percentage number of products or services needing rework.
                    • Percentage of customers ‘very satisfied’.

                    As mentioned above, these indicators may vary; the important thing to keep in mind is that they should serve as a tool for improving the quality of decisions regarding the processes and the ISO 9001 QMS itself.

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                      Effective Internal Audits

                      Internal audits are one of the most important aspects within any management system. It is through audits that gaps, potential problems and possible solutions will be identified in order to maintain and improve the effectiveness of the management system.

                      However, not all audits add value to the system and in order for them to be truly effective it is essential that they are:

                      1. Planned and programmed.

                        The organization needs to carefully determine which processes will be audited (not all have to be audited at once or with the same frequency). In order to do this, they will need to take into consideration the results of previous audits, the complexity and risk of its processes and the maturity of each process.

                        Auditors should consider the natural rhythm of the process being audited, including the synchronization of processes and time and the availability of trained and experienced auditors.

                        Specific timetables should be elaborated and these must be informed in advance within the organization, detailing which processes are to be audited and when.

                      2. Carried out by competent auditors.

                        Auditors must be competent, objective and impartial. They must demonstrate comprehensive knowledge of the processes and the standard which they are auditing against.

                      3. Findings and results are communicated effectively.

                        The findings and their details (nonconformities, positive areas and areas for improvement) should be communicated during the audit’s closing meeting to everyone involved. These findings should also be discussed with the auditee during the audit and before recording it.

                        This information must be communicated in an objective and friendly manner and any suggestions should be informed in a constructive manner.

                      4. Results are recorded and monitored.

                        The results and the corrective actions encountered during the audit must be recorded and monitored in order to ensure that non-conformities are taken care of and improvements made.

                        It is also important to establish who will be responsible for monitoring the actions necessary for closing a non-conformity or implementing an improvement.

                      For internal audits to be effective, it is essential for this process to be carried out together with auditors and auditees. The planning and programming of internal audits must be done taking into consideration information given by all the people involved. Also, everyone must understand that the purpose of internal audits is to identify possible weaknesses and areas for improvement in order to ultimately increase the effectiveness of the organization’s processes and its management system in general.

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