Tags Posts tagged with "process"

process

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ISO 9001 System

Here are some of the most common mistakes made by organizations when managing an ISO 9001 system:

Mistake 1. Top management is not committed to the ISO 9001 system.  If top management is not involved in quality, if they don’t provide the resources and mechanism to plan, control and improve their products, services and processes, ISO 9001 can not be sustained over time. It’s essential for top management to take decisions that demonstrate that quality, improvement and customer satisfaction are an important issue.

 

Mistake 2. Not training key personnel in ISO 9001. Not knowing what ISO 9001 is all about can be a big mistake. It is important for organizations to train key personnel (someone who has a decision-making role) in ISO 9001, in order to understand what ISO 9001 really is and what it requires. Not knowing nor understanding ISO 9001 can take organizations through a path of disappointment and despair.

 

Mistake 3. Not training all personnel. Everyone must receive training on the important quality aspects of the activities and processes they work in. Everyone must understand the importance of quality and how they can achieve it. The training must be consonant with their responsibilities and the activities they perform.

 

Mistake 4. Making the system complex. If the organization is working to keep the system alive, it is a sign that it is too complex and all the work of filling out forms and documenting procedures is not adding value to the organization. The system must be kept simple and practical, and it should focus on results and improvements, and not on documents.

 

Mistake 5. Not using the corrective action process properly. Organizations need to take the time to investigate their problems and involve the right people in the investigation process. Most problems are recurrent, so using the corrective action process correctly will reduce or eliminate their recurrence.

 

Mistake 6. Not knowing what customers want. One of the objectives of ISO 9001 is to improve or increase customer satisfaction, and if organizations do not take the time to listen to their customers, they will not be able to reach this goal. A long and complicated survey is not necessary nor recommended, just by asking a few key questions will give organizations enough information to determine and plan for changes that will aim to fulfill this goal.

 

Mistake 7. Rushing into the implementation process. To build a solid ISO 9001 management system takes work and time.Trying to implement the system in a short time will be counterproductive. Organizations need to take the necessary time to plan, do, check and act in order to implement a system that will improve their products, services and processes.

 

Mistake 8. Not having a trained and experienced internal auditor. In many cases, internal auditors lack the necessary training and experience to distinguish small details from big issues in the QMS. Auditors need to focus on the issues that will help organizations improve their processes and the system itself.

 

Mistake 9. Believing that what works for one organization will work for their own. Every organization is different and what may work for one, may not work for another. Organizations need to focus on their specific context in order to build and develop their management system around it.

 

Mistake 10. Leaving the responsibility of the QMS to one person. ISO 9001 needs to be the work of an entire organization. If people do not take ownership of the QMS, it will not work out. People need to incorporate quality in their work and activities and an outsider will not achieve that. Guidance and training is needed, but if quality is not done on a daily basis in every process then the system will never add value to the organization.

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Process Approach
Process Approach

In the past, most auditors used a formal clause approach when auditing a management system; today, many auditors are leaving behind the checklist that served as a useful guide to identify the conformance with applicable requirements, and are now using a process approach to perform their audits.

Some aspects that give importance to this approach are the following:

  1. Process Approach focuses on results, not on procedures.

    Management systems are not just a set of documented procedures; they are an active system of processes that address business risks and its applicable requirements. By reviewing the process and not just the procedures, it becomes easier to evaluate the results of the process and how effective these really are.

  2. Process Approach determines the effectiveness of the management system.

    Audits conducted using a process approach provide information on whether performance targets are being met, they identify opportunities to improve performance through better process control and determines how processes can be more effective and efficient in meeting the system’s applicable requirements.

  3. Process Approach evaluates links between departments and processes.

    Interactions between the processes of an organization can often be complex, resulting in a network of interdependent processes where the output of a process can be the input of another. By following the flow and continued work throughout the organization, it’s possible to review and evaluate the sequence and interactions of processes, their inputs and outputs and the effectiveness of these interactions.

  4. Process Approach determines whether the operations are under control and whether the controls are effective.

    The process approach not only focuses on whether controls are in place but also on how efficient these really are in maintaining and improving the effectiveness of the process and the system.

  5. Process Approach helps determine the depth of the problems through the organization.

    When a problem is found, it is easier to determine the severity of its impact on the system by reviewing the entire process and it’s interactions with other processes.

  6. Process Approach focuses on the benefits of correcting non-conformities related to improving organizational effectiveness.

    Process based audits help organizations in evaluating the effectiveness of their processes. It serves as a tool to identify weaknesses and opportunities to improve the existing connections between policy, requirements, performance, objectives and goals, which will ultimately contribute to the overall success of an organization.

Management systems are a complex set of interactions between different activities carried out in different areas of an organization. When these activities are viewed as being part of a process, it is easier to understand these interactions and how they go beyond the boundaries of a specific functional unit. Also, by auditing an entire process, the people involved in it will have a greater understanding of how their activities influence the overall effectiveness of the organization’s management system.

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There are different approaches to auditing; these can be performed by clause, department, tasks, etc. The most commonly used by auditors is the clause approach,  where the auditor goes by each clause, usually with a checklist, searching for evidence of requirement conformance and writing nonconformities (minors or majors) if any are found.

These approaches tend to focus mainly on procedures and not on the performance, outcomes and results of the organization’s processes. Hence, audits result in the correction of minor problems and not in the improvement of the system and its processes.

The process approach to auditing focuses on reviewing the sequence and interaction of processes and their inputs and outputs. It analyzes the management system not just as if it were a set of documented procedures, but rather as an active system of processes that addresses business risk and its applicable requirements. The main elements that a process-approach audit reviews are:

  • Process Owners
  • Inputs and Outputs of the process
  • Resources
  • Methods/ Procedures/ Instructions
  • Controls/ Measurements/ Metrics
  • Documents/Records
  • Efficiencies/ Effectiveness

In order to take this approach, it is required to plan and perform the audits so they are based on the processes that achieve organization’s objectives. The audit needs to be conducted through business processes and across department boundaries; some of the processes that need to be audited are:

  • Business management
  • Marketing and sales
  • Resource management
  • Purchasing
  • Product / service production processes

Audits conducted with a process approach provide information on whether performance targets are being met, they identify opportunities for improving performance through a better control of processes and determine how processes can be more effective and efficient in meeting the applicable requirements. Some of the aspects that make this approach a valuable one are:

  • It focuses on results, not on procedures.
  • Determines the management system’s effectiveness.
  • Evaluates the outcomes and results of the system.
  • Evaluates linkages between departments and processes.
  • Follows flow of work throughout organization.
  • Determines if operations are under control and if controls are effective.
  • Allows judgment on significance of findings.
  • Helps determine depth of problems across organization.
  • Focuses on benefits of correcting nonconformities related to improving organizational effectiveness.

Organizations that wish to comply with a standard have to meet the requirements established in it, but in some cases, just meeting these requirements does not necessarily add value to the organization. In order for an organization to be competitive and successful, its operational processes must work together in achieving its goals and objectives. A process based audit assists organizations in assessing the effectiveness of these processes; it serves as a tool to identify weaknesses and opportunities to improve the connections between policy, requirements, performance, objectives and targets, which will ultimately contribute to an organization’s overall success.

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As any other manager, role of the Management Representative is that of planning, organizing, monitoring, evaluating, and reporting.
As any other manager, role of the Management Representative is that of planning, organizing, monitoring, evaluating, and reporting.

Corrective Action is a reactive process; something needs to have gone wrong in order for an organization to take actions to solve the problem or non-conformity. Depending on the way they are approached, non-conformities can be corrected and its recurrence prevented.

Organizations with well-established management systems can find that problems/non-conformities, in their processes, products or services, recur, in spite of all the efforts (time, work and money) spent to eliminate them. In order to ensure that a problem is fixed immediately and in the long-term, an effective corrective action process needs to be established. Here are some characteristics of what makes an excellent corrective action process:

Problems are identified. Problems can occur in processes, in the workplace, in a product or service provided, or in the management system itself. Some of these problems are easier to identify than others; that’s why organizations need to establish ways to identify them through:

  • Workplace and process inspections.
  • Testing, inspecting, and monitoring of equipment.
  • Reviewing interested party’s communications.
  • Audits.
  • Hazard reporting.
  • Investigating complaints, incidents and accidents.
  • Reviewing system failures.
  • Reviewing regulatory requirements.

Problems are temporarily fixed or contained. Most problems need a quick reaction. For that reason, the owner of the task or process needs to be located and informed immediately in order to take the necessary actions to solve the problem temporarily.

The problem’s root cause is found. This is the most important characteristic of an effective corrective action process. If an organization is unable to determine the root cause of a problem/non-conformity, it is condemned to face the same problem over and over, which can be exhausting and discouraging to everyone involved in the process.

There are numerous techniques to determine the root cause of a problem. An organization needs to make sure their employees have the time, resources and the required skills to investigate and draw the right conclusions from these investigations.

A long lasting solution is put in place. After identifying the root cause, an appropriate solution that will prevent the problem from happening again must be proposed. These actions need to be put in place. It’s useless to go through all the work of understanding the problem and identifying its root cause, if the actions to solve it, will not be taken.

Permanent changes are verified. After an appropriate period of time, a person needs to be assigned to verify if the actions were successful in preventing recurrence. It’s recommended that this person is someone that was not involved in the previous steps of this process, to ensure is impartiality.

Corrective actions are recorded. It’s essential to report all the details of the corrective actions: problem found, immediate actions taken, root cause, corrective actions, and verification.

If an organization learns to solve their problems by applying an effective corrective action process, they will ultimately improve their processes, their management system and their business.

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ISO 9001

All management systems require organizations to conduct internal audits in order to obtain information that will evidence the degree to which requirements are being met. In other words, internal audits check practice against policies, processes and procedures and thoroughly document any differences.

Although internal audits are an important tool for organizations to evaluate their management systems and to uncover areas that are in need of attention, for many, this process induces an enormous amount of stress. For audits to serve as a means to identify gaps and effective solutions, it is essential that these are formal, planned and organized. Other key characteristics internal audits should have are:

They are scheduled. Surprise audits are not welcomed by anyone. A schedule should be set and communicated to everyone, preferably at the beginning of the year. There’s no need to audit all processes at once; different processes can be audited at different times throughout the year, organizations just need to make sure that at the end of the year all processes have been audited.

Auditors are competent. Auditors need to demonstrate in-depth knowledge of the standard which they are auditing against and they should have an understanding of the processes being audited. They should be objective and impartial; this means that they can’t audit a process which they manage or control. Large organizations usually have a team of trained auditors, but that is not necessary; an alternative is to hire the services of an external consultant to perform the internal audits.

They are planned. The audit needs to be confirmed with the process owner. At this stage the auditor should review procedures and previous findings or issues related to the audited process. A checklist with a pre-determined list of questions can be sought to be used during the audit; this checklist should be provided to the auditee so they have time to organize any information.

It’s conducted in an objective and friendly manner. An audit should start with an opening meeting with the auditor and the auditee(s). It’s recommended that the auditor works systematically through the checklist or procedure, while reviewing records, observing the process, analyzing process data and talking to employees. During the audit, the auditor must discuss the findings with the auditee before recording it.

Audit findings are recorded. A closing meeting with the auditee is fundamental so information is not delayed. Here the auditor should point out possible weaknesses and areas for improvement. Findings and their details (these include non-conformities, positive areas and improvement areas) need to be recorded and communicated to the auditee(s) and management.

Findings are monitored. The auditor is responsible for ensuring that corrective actions have been taken to fix any problems found during the audit.

If everyone takes advantage of the positive results internal audits can bring, and if these aid organizations to improve their processes and management system- whether is a quality, environmental or any other system- an internal audit can be considered a success.

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PAS 99:2012 is based upon the structure of ISO Guide 83, and now sets a common structure to be followed by all management system standards moving forward.
PAS 99:2012 is based upon the structure of ISO Guide 83, and now sets a common structure to be followed by all management system standards moving forward.

All management systems require a periodic review by the organization’s top management. The purpose of such a review is to evaluate if the management system is performing as intended and if it’s producing the desired results as efficiently as possible. While in review, there are steps that can be taken to make sure your organization’s management review process goes smoothly.

The management review inputs may vary from standard to standard; however, there are some key characteristics that all management reviews should have to ensure its success. These are:

Top management is involved. In order for this process to have the expected outputs, top management needs to attend; they are the ones that decide where the resources – people, time and money- will be placed to improve the management system.

All the required inputs are presented in a simple and clear manner. Every standard is specific about the review’s inputs. This information can sometimes be extensive, therefore, it’s fundamental that it’s presented in an easy to follow way and that it gives an overview of the systems current status, its weaknesses and possible areas for improvement. Here are some examples of the information that needs to be highlighted:

  • Internal and external audit results. Number of audit findings. Their current status. Are audit findings increasing or decreasing compared with the year before?
  • Corrective and preventive actions. Current status of corrective/preventive actions. Are resources available to effectively close them? Possible trends (are there fewer corrective and preventive actions compared to previous years?)
  • Legal compliance. Is the organization complying with all applicable requirements?
  • Process performance. Are targets/objectives being reached and maintained?
  • Communications and complaints. Has positive or negative feedback been received from interested parties?
  • Upcoming changes. Are there any changes that can affect the effectiveness of the system (staff changes, new projects or standards, efficiency improvements, etc.)? What actions/decisions need to be taken?

Outputs are recorded. It is essential to record, as a minimum, the date of the review, participants in the review, decisions taken, deficiencies found in the system and recommendations for improvement or corrective actions. The actions and recommendations to be taken should stipulate deadlines, resources needed and the individuals responsible for the actions.

Management review outputs are monitored. The results of this review should be monitored over time, and if problems persist, more frequent reviews should be scheduled.

Management review is held frequently enough. This review is required at least once a year. It is recommended that during the first two years of the management system, this review is held more frequently (twice a year), and after the system has “matured” it can be performed once a year. However, if it’s considered necessary, a specific topic (audit findings, corrective actions, process performance, etc.) can be reviewed on a more frequent basis.

Broadly speaking, a successful management review process provides top management and everyone responsible for the effectiveness of the management system, a diagnosis of the system’s current situation so deficiencies can be identified, changes and/or actions can be established to correct these deficiencies and recommendations for improvement can be made.