API Q1 6  Quality Management System Monitoring, Measurement, Analysis, and Improvement

6.1 General

The organization must plan and implement the monitoring process, measurement process, analytical process, and improvement process to confirm to the requirements of API Q1 and to continually improve the effectiveness of the quality management system. The process must include applicable methods, including techniques for the analysis of data, and the extent of their use.

The organization to must analysis the results of monitoring and measurement and confirm that organization has considered what, how and when to measure and that the outcomes from decisions result are ensuring appropriate process control. It must monitor the performance and effectiveness of organization’s quality management system. It must develop a process (method, techniques, format, etc.) to identify, collect and analyze various data and information from both internal and external sources, including:

• Monitoring and measuring results;
• Process performance results;
• Meeting objectives;
• Internal audit findings;
• Customer surveys and feedback;
• 2nd or 3rd party audit results;
• Competitor and benchmarking information;
• Product test results;
• Supplier performance information.

This ‘input’ (information and data) should reflect upon the adequacy, suitability and effectiveness of the quality management system and its processes. The ‘output’ (result of the analysis) must provide information (understanding, insight, awareness, confidence, knowledge of, etc.). The analysis output must provide insight to:

• Customer satisfaction and perception
• Product conformance.
• Process performance
• Product and process characteristics
• Trends in products and processes
• Opportunities for preventive action
• Suppliers and subcontractors.

Other potential or useful options might include:

• Need for corrective action
• Opportunity for improvement
• Competition.

It is important to document and retain as evidence the results of the evaluation of the performance of the quality management system. Monitoring and measuring QMS operations and activities will establish a mechanism to ensure that your organization is meeting its policies, objectives and targets. In order to meet this requirement, your organization must perform six steps:

• Identify the activities that can have a significant impacts and risks
• Determine key characteristics of the activity to be monitored
• Select the best way to measure the key characteristics
• Record data on performance, controls and conformance with objectives and targets
• Determine the frequency with which to measure the key characteristics
• Establish management review and reporting.

Establish the monitoring and tracking criteria for each activity that has a significant impact or risk and review the action plan.

6.2 Monitoring, Measuring, and Improving

6.2.1 Customer Satisfaction

The organization must establish a documented procedure to measure customer satisfaction. The procedure shall address the frequency of measurement, obtaining customer feedback, key performance indicators (KPIs), and other information that the organization uses to determine whether the organization has satisfied customers in meeting identified requirements. The result customer satisfaction information must be recorded.

Customer satisfaction should be monitored to determine to which degree their expectations and needs are being fulfilled. The methods for obtaining this information need to be determined by the QMS. Methods of measuring and monitoring the way customers perceive your company can be done through;

• Physical customer feedback through meetings
• Customer surveys
• Warranty/Guarantee claims
• Compliments/Complaints
• Dealer reports

Producing high levels of customer satisfaction is an essential metric tool for gathering real-time information to improve the QMS system and product. Each customer will be different and present different needs and the organization will have to use additional measures and controls to measure and analyze the data.

Defining Customer Satisfaction Indicators: The procedure for customer satisfaction should have a customer satisfaction indicators. This process should also include;

• The frequency of data collection
• The method of data collection
• A summarization
• A review of the data
• An evaluation of the data
• Actions on how to improve
• The required timeline for remedy
• Whose responsibility it is and
• The follow-up with the customer

To continuously improve on customer satisfaction, customer feedback and trends must be constantly. This will be the baseline to use for both internal and external customer.

6.2.2 Internal Audit

6.2.2.1 General

Internal Audits are conducted to verify that the Organization’s QMS is effectively implemented and maintained and conforms to the requirements of the API Q1. The organization must establish a documented procedure for Internal audit. It must define the responsibilities for planning, conducting, and documenting internal audits. The results of previous audits and criticality of the process being audited must be considered while planning for internal audits . While planning for the internal audit the organization must identify the audit criteria, scope, frequency, and methods of Internal audit. The procedure must ensure that all processes of the quality management system claiming conformity to the API Q1 requirements are audited at least once. every 12 months. All Outsourced activities that impact the quality of the product and that are performed at the organization’s facility must be part of the internal audit .

6.2.2.2 Performance of Internal Audit

All processes of Organization’s QMS must be audit to claim conformance to the API Q1 requirements. Records of the audits provides objective evidence that the QMS is implemented and maintained . Independent , Competent personnel who do not perform or directly supervise the process being audited shall conduct the Audit. This is to ensure objectivity and impartiality of the audit process. Product specification requirements can be embedded throughout the quality management system processes and audited in conjunction with one or more quality management system processes.

6.2.2.3 Audit Review and Closure

For the non-conformities identified during the internal audit , the responsible management must ensure necessary correction and corrective action. The organization must identify response times to addressing detected non-conformities. Records related to internal audits must be maintained. The results of internal audits and the status of corrective actions are to be reported in the management review.

Organization should establish an internal audit plan to cover all requirements of the standards. In addition, consideration should be given to the status and importance of the processes that comprise the audit and the results of previous audits. Objective evidence should demonstrate information of concerning the effective implementation the audit plan, as well as a sample of audit results. The internal audit process should include the following activities:

• The development of a program of internal audits which can be revised depending on the results of previous audits and the results of performance monitoring.
• The identification, selection and training of internal auditors.
• The analysis and evaluation of the results of internal audits.
• The identification of the need for corrective or improvement measures.
• The verification of the completion and effectiveness of these measures.
• The documentation pertaining to the execution and results of audits.
• The communication of the results of audits to the top management.

The internal audit process is part of the continual improvement feedback loop to evaluate and improve the effectiveness of the management system. It also highlights where processes and procedures are not addressing risks adequately and where changes are needed to improve efficiency or effectiveness. The audit process also serves as a method of compliance monitoring.

Planning for internal audit

During the early stages of implementing of this standard , the internal audit often focuses on ensuring that any compliance issues or non conformities are discovered and rectified prior to the assessment. However, once organization is registered, the internal audit must evolve. The focus of the internal audit planning should be re-directed, away from compliance with standards, to an audit strategy that bases the audit frequency upon process performance data, feedback from customers, etc., to ensure that you are focusing on the risks and issues that should be on Top management’s radar. When planning the Internal audit organization should ensure that customer feedback, organizational changes and risks and opportunities are brought into consideration. Process importance as the degree of direct impact that process performance has on customer satisfaction should be considered i.e. could the process provide the customer with a defective product? One should consider process status in terms of maturity and stability; a more established, proven process will be audited less frequently than a newly implemented or recently modified process. Conversely; processes which are not performing to the planned arrangements should be audited more frequently. Support processes should be given a lower ranking than the manufacturing/service provision processes. In addition, the results of previous audits should be considered too. Processes that have been audited recently that have shown effectiveness and improvement should be audited less frequently. When applying risk-based thinking to select internal audits and their frequency, consider the following:

• Processes that are critical to product and service quality;
• Complex processes that require close monitoring and control to ensure conformity;
• Balance across operational and non-operational processes;
• Processes that utilize qualified personnel;
• Activities or processes that occur across multiple locations;
• Processes impacted by human factors;
• Introduction of new or changed processes;
• Changes affecting the organization;
• Statutory and regulatory issues;
• Process performance, e.g. process conformity/non-conformity, escapes to the customer, complaints, previous internal/external audit results, identified risk.

When planning your internal audit one should ensure that customer feedback, organizational changes, and risks and opportunities have been brought into consideration. Internal audit that are based on risk and customer feedback will help your organization to embark upon new methods of compliance in which risk-based thinking and continual improvement are the drivers, rather than compliance.

Determining the frequency of internal audits
Deciding the frequency of internal audits will depend on the perceived need for the audit and the size and complexity of your organization. The frequency of internal audits should depend on the criticality of each process and the perceived need to audit it, but all processes should be formally audited at least once during a 12-month audit cycle. Critical processes that directly affect process and product conformity, and customer satisfaction should be audited more frequently, e.g. monthly, quarterly, or more regularly as required. When determining internal audit frequency, you should consider the following:

The level of risk associated with the activity, policy or procedure;
The priority of the specific element of the management system;
The results of previous audits; and
The significance of problems identified in the areas to be audited.

The basic requirement of the quality management system is that it is audited at least once per year. If many issues are found during audits, then additional audits can be undertaken to help get that part of the system working effectively again as soon as possible. ISome audits are likely to be conducted on a monthly basis in order to cover all manufacturing processes over the year. Unscheduled audits may be conducted at any time based upon:

Previous audit results;
Regulatory inspections;
Operational changes (planned or unplanned);
Management review concerns;
Identified non-conformances.

The frequency of internal audits should be reviewed and, where appropriate, adjusted based on occurrence of process changes, internal and external nonconformities, and/or customer complaints. The effectiveness of the audit should be reviewed as a part of management review.

The internal audit checklist is just one of the many tools which are available from the auditor’s toolbox that help ensure your audits address the necessary requirements. The checklist stands as a reference point before, during and after the audit, and will provide the following benefits:

• Ensures the audit is conducted systematically;
• Promotes audit planning;
• Ensures a consistent audit approach;
• Actively supports your organization’s audit process;
• Provides a repository for notes collected during the audit process;
• Ensures uniformity in the performance of different auditors;
• Provides reference to objective evidence.

Before a new audit is started in a particular area, it is important to check the status of any outstanding issues since the last audit (if any) was performed in the area. If there are outstanding issues, then they may be carried forward into the current audit, and the previous audit could then be closed off. The system audits are best undertaken using and internal audit checklist. This type of audit focuses on the quality management system as a whole, and compares the planning activities and broad system requirements to ensure that each clause or requirement has been implemented. A good summary report is the final output of the audit and deserves an appropriate amount of attention and effort. The audit report is the detail of what was found during the audit. It presents an overall summary of the audit findings, as well as any positive aspects noted during the audit. The audit report must also identify nonconformities identified during the audit and their associated corrective actions. The Internal Auditor should be responsible for finalizing the audit report, which should include:

• The area and element/procedure/process audited;
• Audit team composition, audit scope, persons interviewed;
• Executive summary;
• Observations and key findings (identified nonconformities);
• Recommendations;
• Opportunities for improvement, which are areas that may become nonconforming in the future;
• Graphical representation of findings.

On completion of the audit, a closing meeting should be scheduled between the audit team and the organization or department being audited, to present the results of the audit and discuss any subsequent steps required to complete the audit. Observations may also be recorded for future consideration. The audit report needs to be signed by the lead auditor and the manager of the relevant department, and distributed as required to relevant persons. The findings and conclusions should be formally documented as part of the summary report. Too often, the audit report only recites back facts and data the managers already know. The value is in identifying issues and opportunities they do not know! This summary should be reviewed first with the lead auditor, then the Process Owner and Management Team. Make final revisions and file the audit report and all supporting audit materials and notes. The audit summary and the corrective action forms should be attached to the audit report, which now becomes the audit record. Only the summary report and corrective actions need be given to the Process Owner and a copy of the audit report should be given to Top management.

6.2.3 Process Evaluation

Suitable evaluation methods must be applied on the QMS processes to ensure that QMS processes achieve planned results, including conformity to product requirements. When are not achieved, correction and corrective action shall be taken as appropriate. Process evaluation can be done by performance of internal audits and management reviews

Process evaluation is about auditing your organization’s processes and their interactions, which together comprise the quality management system. The process audit provides assurance that the processes have been implemented as planned and provides information on the ability of the process to produce a quality output. Use the process audit template for conducting an in-depth analysis to verify that the individual processes comprising the management system are performing and producing outputs in accordance with the planned outcomes. The process audit also identifies any opportunities for improvement and possible corrective actions. Process audits are used to concentrate on any special, vulnerable, new or high-risk processes. A process is a set of interrelated activities that transform inputs, such as materials, customer requirements and labor, via a series of activities into outputs, such as a finished product or service. Various stages of the process must meet various applicable clauses of the standard. There are six characteristics to look out for when auditing a process:

Does the process have an owner?
Is the process defined?
Is the process documented?
Are links between other processes established?
Are processes and their links monitored?
Are records maintained?

The process audits must be scheduled according to the processes defined by your management system. The audit schedule should not be based on the clauses of the standard, but it should instead be based upon the importance and criticality of the process itself. The process approach to auditing should cover three vital stages:

• Preparing for the audit;
• Auditing the process and its linkages;
• Preparing the summary and audit report.

An audit of each process should be conducted at planned intervals in order to determine whether the processes conform to planned arrangements in order to determine whether the process is properly implemented and maintained and to provide process performance information to top management. Effective process auditing requires the auditor to identify and record audit trails that will make a difference to the organization. The audit should begin with the process owner in order to understand how the process interacts with the other process inputs, outputs, suppliers and/or customers.

6.3 Analysis of Data

The organization must establish a documented procedure for the identification, collection, and analysis of data to demonstrate the suitability and effectiveness of the quality management system. The analysis includes data generated from monitoring and measurement, internal audits , management reviews, and other relevant sources. The data analysis output provides information relating to customer satisfaction, quality objectives, supplier performance and conformity to product requirements. The nonconformities and product failures identified after delivery or use, provided the product or documented evidence is available to facilitate the determination of the cause. The characteristics and trends of processes and products including opportunities for preventive action. The organization must use data to evaluate where continual improvement of the effectiveness of the quality management system can be made.

Analysis of Data must include:

• Levels of Customer satisfaction
• Level of Supplier performance
• The results of product and process monitoring
• Rates of non-conformances
• Trends and opportunities for corrective and preventive action

Where the analysis shows unacceptable performance then those items should become Quality objectives and where appropriate, become subject to preventive or corrective action.

The purpose of analyzing data is to:

• Assess organizational performance against established plans and stated quality objectives
• Identify areas for improvement
• Help determine the cause of problems
• Provide guidance for determining the most appropriate corrective or preventive action to take

Data collected for analysis includes:

• Results from customer surveys
• Results from employee surveys
• Customer, supplier and employee feedback
• Results from internal audits
• Results from process monitoring and measurements
• Results from product monitoring and measurements
• Non-conformance reports
• Warranty claims and returned products
• How do I analyze data?

Effective data analysis is an essential part of any quality management system:

• Use statistical techniques where appropriate (e.g. Statistical Process Control)
• Data should be analyzed by designated, competent personnel
• Use data feedback for continuous product and process improvement
• Should I document our analysis of data process?

It is not a mandatory requirement to document your analysis of data process. However, you should always look to adequately define and control any operational processes that generate information on the performance of your quality management system. Therefore, the implementation of an analysis of data procedure will be appropriate to the majority of businesses. Develop and implement a procedure that defines the roles and responsibilities for analyzing quality management system data in order to drive continual improvement and to facilitate a factual approach to decision making:

• Data collection
• Data analysis
• Information output
• Reporting
• Looking for help documenting the process?

The effectiveness of the analysis of data process is often determined by looking for evidence that the organization has sufficiently utilized data from the outputs of its activities and has used that data to drive continual improvement and enhance customer satisfaction.

6.4 Improvement

6.4.1 General

The organization must look to continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review. The definition of correction, corrective action, and preventive action ans given in ISO 9000 is applicable here.

The organization is expected to revise the quality system documentation and processes as the quality management system matures or when a new process is implemented. The organization must identify improvement opportunities and management system underperformance using the data output from its processes, such as data analysis and evaluation, internal auditing, management review, and the use of appropriate tools and methodologies to support validate findings. The organization must implement the identified opportunities for improvement in a controlled manner.The organization should ensure that it has implemented a process, with appropriate methods, techniques, and formats for identifying areas of underperformance or opportunities for improvement. The organization should select the appropriate tools and techniques to investigate the causes and thereby establishing and implementing a process for continual improvement. The impetus for continual improvement must come from the use of (as a minimum):

1. Policies;
2. Risks and opportunities;
3. Objectives;
4. Aspect and impacts
5. Hazards and safety risks;
6. Analysis and evaluation of data;
7. Audit results;
8. Management review;
9. Non-conformity and corrective action.

Processes can always be made more efficient and effective, even when they are producing conforming products. The aim of a continual improvement programme is to increase the odds of satisfying customers by identifying areas that need improvement. It requires the organization to plan improvement systems and to take into account many other activities that can be used in the improvement process. You will be required to ensure that you continually improve the degree to which your products and services meet customer requirements and to measure effectiveness of your processes. To this end the continual improvement principle implies that you should adopt the attitude that improvement is always possible and your organizations should develop the skills and tools necessary to drive improvement.

6.4.2 Corrective Action

The organization must establish a documented procedure to correct non conformities and to take corrective actions appropriate to the effect of nonconformity to eliminate the causes of non conformities to minimize the likelihood of its recurrence. Corrective action are to apply both internally and within the supply chain to both quality management system processes and nonconforming product trends. The procedure must identify requirements for reviewing a process nonconformity including customer complaints, determining and implementing corrections, identifying the root cause of the nonconformity and evaluating the need for corrective actions , implementing corrective action to reduce the likelihood that a nonconformity recurs, identifying the time frame and responsible persons for addressing corrections and corrective action, verification of the effectiveness of the corrections and corrective action taken and Management Of Change when the corrective actions require new or changed controls within the quality management system. Records of the activities for control of a nonconforming process shall be maintained. Records shall identify the activities performed to verify effectiveness of the corrective actions taken.

Definition of correction
Correction (also referred to as immediate correction) is action taken to eliminate a detected nonconformity or defect (adapted from ISO 9000). A correction can be made in conjunction with undertaking corrective action. For a product nonconformity, correction might include reworking the part, accepting the nonconformance through the concession process, replacing the product, or scrapping the product.

Definition of corrective action
Action implemented to address the root-cause and contributing cause of the undesirable condition, situation, nonconformity, or failure; action taken to prevent recurrence. As part of the corrective action process you must identify all the causes (root-cause and contributing causes) that have or may have generated an undesirable condition, situation, nonconformity, or failure.

The decision to apply or not apply the corrective action process should be made by the appropriate level of management within the company, based on the level of risk. Many factors that can trigger the corrective action process, examples include:

• A safety impact that affects the product or personal;
• Product performance and/or reliability issues;
• High impact on production and/or maintenance operations;
• Repetitive problems to one part of the activity/process, or similar problems across many activities/processes;
• Difficulty in detecting the nonconformity;
• By customer request;
• Significant quality or management system issues;
• Complex problem that cannot be solved without assistance of others not located where the problem occurred.

The analysis of nonconformities should not look for someone to blame, or a department that is ‘more responsible than another’, but rather for understanding and improving the organizational weaknesses that made them possible. Where internal audits identify that organization’s policy, objectives, standards and other requirements as outlined within their management system are either not implemented, or are improperly implemented, a nonconformance report should be raised and entered into the nonconformity log as appropriate. This should require an agreed response from the relevant Line Manager prior to closure. The root-cause must address the nonconformity and the corrective action must address the root-cause. Any nonconformities and subsequent actions to prevent their reoccurrence and the effectiveness of the corrective action(s), should be duly documented and retained.

Step 1. Identify the Problem
Once a problem has been identified through inspection, customer complaints, or audit results, it should be captured using non-conformity reports (NCRs) or corrective action reports (CARs) in order to identify who is affected by the problem and what the impact is. Considering the following:

• What are the operations, products, materials, defects, malfunctions that may characterise the problem? What is it about?
• Who is concerned with the problem? Who is reporting the problem? Who is rectifying the problem? Who is the problem affecting?
• Where are all the places where the event takes place; shop floor, services, machine, process step?
• Where is it seen? Where does it originate?
• When does the event appear (time, date, when does it start, how long does it last, how often)
• When is the problem reported defective? When is the problem repaired?
• Has it occurred before? If yes, what is the history?
• How do we know there’s a problem (how is it detected)?
• How does the event appear, how does it stop?
• How frequently is the problem experienced?
• How is the effect of the problem being measured (costs, delays, scrap rate, customer complaints, return rate, concessions, reliability rate, etc)?
• How is the problem currently addressed? How is it corrected?

This step helps to fully describe a situation, precisely analyse all its elements and gain a common understanding of them, allowing the definition of an action plan. Ensure that all team members agree about the definition of the issue and resulting impact. The problem description should describe the problems in terms of what, where, when, and how big. On a flip chart, presentation board, or even paper; write out a description of what you know about the problem. Try to document the problem and describe it as completely as possible. The description should contain facts; such as observations and documentary evidence and not assumptions. All information must be gathered before identifying the root-cause can begin. Make sure both of the above factors are true before you move to the next step. Consider any new information that the team may have gathered since completing the initial problem description. Describe the problem by identifying what is wrong and detail the problem in quantifiable terms. Define, verify and implement the interim containment action to isolate the effects of the problem from any internal/external customer until Permanent Corrective Actions (PCA) are implemented.

Step 2. Establish a Response Team
Identify representatives from functions that may have an influence on the corrective action process, including the identification of the root causes. Remember to assign responsibilities and objectives to the team members. Remember, those performing the job, such as operators, inspectors, drivers, etc., are the best people to help identify the real causes, don’t leave them out of the team! The size and composition of the team should depend on the complexity and the impact of the problem. The composition of the team is not fixed forever and may evolve depending on the analysis results and the required actions. New team members should join the team if analysis shows they are identified as being in the scope, some others will leave if their area is definitely identified as out of the scope. However, consideration should be made that expending the size of the core team over 6 to 8 members generally results in less efficiency. When more members or special skills are required, sub teams should be considered. Don’t forget, root-cause analysis must not be used for assigning blame or transferring responsibility. In summary, you should establish an investigation team with:

• Process and/or product knowledge;
• Allocated time and resources;
• Authority to solve the problem and implement corrective actions;
• Skill in the required technical disciplines;
• A designated Team Leader.

Brainstorming sessions should be used to identify potential causes to investigate each potential cause. Coordinate parallel activities with different team members to help expedite the process of verification. Once you have reviewed the problem description, you can undertake a comparative analysis. A comparative analysis will help you identify relevant changes in a change-induced situation. Then you can reduce the number of possibilities that you must consider to determine root-cause. To complete a comparative analysis:

• Ask yourself; what is unique, peculiar, different, or unusual about the symptoms?
• Consider features such as people, processes, materials, machines and the environment;
• List all facts without prejudice as to the possible cause;
• Consider each difference you listed, and look for changes, ask yourself what has changed to give rise to this difference?
• Keep in mind that each difference may not have a corresponding change;
• List the changes next to the difference;
• Look at the dates each change occurred;
• Eliminate some changes if they occurred after the problem started;
• Consider categories of people, machines, processes or measurements.

If the problem is change-induced, the root-cause must be the result of a change relative to one or more of the identified changes. It is important to remember that you have not yet moved from the ‘observations’ phase of the process. Any information you develop during the comparative analysis must be fact based, not opinion based and must be true only for the symptom’s information. Do not rule out any facts that might be valid answers. If it is a fact and it answers the question, write it down. Your organization should first contain the problem by taking immediate corrective action (ICA) and then evaluating the need for initiating the formal problem-solving process. Where necessary, provide an emergency response action to protect the customer from the problem, protect the customer operations and the organisation (to stop the problem getting worse) and verify that problem does not degrade until the root-causes are known. An interim containment action is kept in place until a verified permanent corrective action can be implemented. In some cases, the interim containment action may be the same as or similar to the emergency response action. An interim containment action provides more opportunity for investigation. Conduct trial runs whenever possible. However, in some situations, your verification may simply be a matter of common sense. For example, if an interim containment action involves stopping the shipment of all products, you can be sure that customers will stop experiencing the problem. An interim containment action can be any action that protects the customer from the problem. However, before you implement an interim containment action, you need to verify that the interim containment action will work. To verify the interim containment action:

• Prove before implementation it protects the customer from the problem;
• Provide a before-and-after comparison;
• Prove that the interim containment action will not introduce any new problems.

Methods of verification may include:

• A test to determine the desired performance level;
• A demonstration that changes eliminated the issue without creating a new problem;
• A comparison between the interim containment action and similar proven actions;
• A review to evaluate whether the interim containment action was effective;
• Assurance that the interim containment action did not introduce a new problem.

Any interim containment action you implement must protect the customer from the problem without the introduction any new problems. Also, a single interim containment action may not be enough. You may need to implement more than one interim containment action to fully protect the customer.

Step 3. Identify the Root-Cause(s)
Root-cause analysis (RCA) is a class of problem-solving methods aimed at identifying the root-causes of problems or events. The practice of root-cause analysis is predicated on the belief that the problems are best solved by attempting to correct or eliminate root-causes, as opposed to merely addressing the immediately obvious symptom. Listed below are various root-cause analysis techniques, we recommend you use the 5-Whys (1st Why, 2nd Why, 3rd Why, 4th Why, and 5th Why – and the root-cause) technique to problem solving but you are free to undertake any of the following depending on the complexity of the problem:

• 3-Ws (what, where, when);
• 8D Eight Dimensions;
• Failure Mode and Effects Analysis (FMEA & DFEMA);
• Fish-bone Analysis;
• Pareto Analysis;
• Fault-tree Analysis;
• Cause Mapping – draws out, visually, the multiple chains of interconnecting causes;
• Barrier analysis – a technique often used in process industries;
• Change analysis – an investigation technique often used for problems or accidents.

The 5-Whys technique offers some real benefits to organizations with varying degrees of management system maturity:

• Simplicity. It is easy to use and requires no advanced mathematics or tools that allows you to dig deep and find underlying issues rather than using quick-fix solutions;
• Effectiveness. It helps to separate the symptoms from the causes and identifies the root-cause of a problem using evidence-based analysis;
• Comprehensiveness. It aids in determining the relationships between various problem causes and allows you to proactively eliminate problems for good;
• Flexibility. It works well alone and when combined with other quality improvement and troubleshooting techniques such as ones listed above;
• Engaging. By building a culture that embraces progress, by its very nature, it fosters and produces teamwork within and outside of the organization, encourages the reporting of issues without fear or judgement;
• Inexpensive. It is a guided, team focused exercise that seeks to improve and adapt processes to ensure long-term success. There are no additional costs.

Launching a formal root-cause analysis and problem-solving process should always be considered when an issue; such as, undesirable conditions, defects and failures are detected. The decision not to apply the process must be made based on objective evidence of absence of risks!

Step 4. Implement Corrective Action
When all root and contributing causes have been identified and their effects understood, implement all selected corrective actions. Verify that the planned actions were taken as scheduled and assess their effectiveness in permanently preventing the undesirable condition, situation, non-conformity or failure from recurring. Steps for corrective action (CA) implementation:

• Implement the corrective action (CA);
• Implement controls;
• Evaluate the corrective action (CA) for escape point;
• Remove the immediate containment action ;
• Perform validation;
• Confirm with the customer that the symptom has been eliminated.

To ensure the most effective corrective actions to address the most likely, or critical root causes are taken in consideration of operational and business constraints such as costs, lead time, difficulty of implementation, and resources. Select solutions that optimise value and effectiveness for all stake-holders! Implement the solutions that have been selected, verify that all actions have been completed to schedule and that they have prevented the undesirable condition, situation, non-conformity or failure from recurring. Plan and implement selected permanent corrective actions. Remove the interim containment action and monitor the long-term results.

Step 5. Prevent Recurrence
Modify the necessary systems, policies, practices and procedures to prevent recurrence of this problem and similar ones. Make recommendations for systemic improvements as necessary:

• Review the history of the problem;
• Analyze how the problem occurred and escaped;
• Identify affected parties;
• Identify opportunities for similar problems to occur and escape;
• Identify practices and procedures that allowed the problem to occur;
• Identify practices/procedures that allowed the problem to escape to the customer;
• Analyze how similar problems could be addressed;
• Identify and choose appropriate preventive actions;
• Verify preventive action and its effectiveness;
• Develop action plan;
• Implement preventive actions;
• Present systemic preventive recommendations to the process owner.

Serious consequences may occur when the underlying symptoms are not addressed, when the quick fix is accepted as a final, permanent solution. Excessive reliance on containment or emergency response action will create a repeating cycle. Problem containment is an addiction that will only get worse until the root-causes are found and addressed.

Step 6. Monitor Effectiveness
Establish a review process to ensure corrective actions are completed according to plan and that they continue to be effective over time by confirming you have done what you have planned. Try adjusting the type and number or frequency of additional checks and audits to check that the actions remain effective. When same problem has been identified or is suspected to occur on same or similar products, processes or data, the same corrective actions must be implemented and their effectiveness verified for all these additional products, processes or data. The owner of each corrective action, the team leader and all team members should verify the effectiveness of the actions taken to date, and when relevant, the customer. Examples of verification methods include:

• Additional process monitoring until it is demonstrated that the process is stable and capable of consistently meeting requirements (recording and analysis of process parameters and/or product characteristics, SPC, etc.);
• Additional internal audits to specifically verify the effectiveness of the corrective actions;
• Associated metrics showing significant improvement resulting from the corrective actions.
• Examples of supporting evidence might include: updated procedures, work instructions, control plans, etc. to show any changes were defined. Additionally, evidence of effective implementation of the changes is also required such as SPC data, inspection records, training records, audit records, etc.

If the corrective actions are effective, evaluate which containment actions may be eliminated (e.g. stop over inspection and over production, return to normal transportation means, etc.) without adversely affecting the product and process output. Record evidence of actions completed and associated results (what works and what does not). To document analysis results and changes to make the corrective action permanent, capture and share learning with all the stakeholders to prevent similar undesirable condition, situation, non-conformity or failure occurring on other products, production lines, factories or suppliers. Identify all that can be shared from the experience that can be transferred across business units, production lines, factories or suppliers. Ensure that you get agreement from appropriate levels of management and other process owners and functions (internally and externally) to launch actions and verify there are implemented and effective. Keep lessons learned register which includes a summary of content and results of analyses, flow charts, data bases, performance data, main actions and decisions, location where detailed data can be retrieved, difficulties encountered when managing the issue, etc. When the decision is made to implement actions in another business areas, such as; production lines, factories or suppliers, which are not under direct control of the response team, implementation and the verification of effectiveness is not necessarily the responsibility of the team. Escalation to top management or transfer to another function (procurement, engineering, etc.) may be required to ensure proper leverage and action follow-up.

6.4.3 Preventive Action

The organization must a documented procedure to determine and implement preventive actions appropriate to the effects of the potential problems to eliminate the causes of potential nonconformities in order to minimize the likelihood of their occurrence. Preventive action should be applied internally and within the supply chain to both quality management system processes and product analysis. The procedure should identify requirements for opportunities for improvements, potential nonconformity and its potential causes,evaluating the need for preventive action, including any immediate or short-term action required, to prevent occurrence of a nonconformity, the timeframe and responsible person for implementing a preventive action, the effectiveness of the preventive action taken and Management of Change when the preventive action require new or changed controls within the quality management system. Records of the activities for control of potential process nonconformities must be available.

Preventive action is taken to fix the cause of a process problem before it can happen. In a management system, a preventive action (PA) definition could be: “the activities taken by the organization to eliminate the cause of a potential process nonconformity.” If you are identifying potential problems that could happen in a process, assessing what could cause these problems, and taking action to prevent the problem from occurring before it happens, then you are taking preventive action.Preventive actions are taken to prevent a potential problem, organizations try to address problems before they happen. Whereas corrective actions are taken after a problem has occurred.Corrective actions are taken after an incident occurs to fix and prevent the recurrence, whereas preventative actions are taken before the occurrence to prevent the potential problem. Preventive actions are proactive while corrective actions are reactive.For instance; a pipe burst and a water flooding incident occurred. The corresponding corrective actions address the root cause of the flood, such as fixing old pipes. Contrary to this turning off the water source is a correction that eliminates the cause temporarily. But if the organization controls their pipes regularly and realizes that a pipe is going to burst, at that time they can take preventative actions to prevent the occurrence, before it happens.

Preventative action is an action to eliminate the cause(or causes) of the potential nonconformity and to prevent occurrence.

the following enlisted requirements should be documented in a procedure;

• Determine the potential nonconformity (nonconformities)
• Review the need for possible actions to prevent the occurrence
• Plan and document the action(s) and implement it(them)
• Verify that the action does not adversely affect the current requirements which are already complied with.

The last thing that the organization should perform at the end of each nonconformity management. Review the effectiveness of the taken action after a defined period

6.5 Management Review
6.5.1 General

The organization‘s quality management system shall be reviewed at least every 12 months by the organization’s management to evaluate the quality management system’s continuing suitability, adequacy, and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

6.5.2 Input Requirements

The input to management review shall include, as a minimum:
– effectiveness of actions resulting from previous management reviews
– results of audits
– changes that could affect the quality management system, including changes to legal and other applicable requirements
– analysis of customer satisfaction, including customer feedback
– process performance
– results of risk assessment
– status of corrective and preventive actions
– analysis of supplier performance
– review of the analysis of product conformity, including nonconformities identified after delivery or use recommendations for improvement

6.5.3 Output Requirements

The output from the management review shall include a summary assessment of the effectiveness of the quality management system. The assessment shall include any required changes (see 5.11) to the processes and any decisions and actions, required resources, and improvement to products in meeting customer requirements. Top management shall review and approve the output of management reviews. Management reviews shall be documented and records of these reviews shall be maintained .

The management review must address the possible need for changes to policy, objectives, targets, and other elements of the management system. Here’s what management systems standards are really all about: defining a policy and creating a plan with relevant objectives. You then implement the system according to the plan and begin auditing, monitoring and measuring performance against the plan and reacting to your findings. As such; management review meetings provide useful insight into the operation of the management system and its processes to enable Top management to respond to issues and to recommend improvements.

It is important that a member of Top management chairs the management review meetings. It is imperative that everyone involved with the management review process fully understand and appreciate the management review requirements. Other attendees at management review meetings should include functional management, line management, process owners, process champions, lead process users, and action owners within the scope of the quality management system, as appropriate, and the internal auditor(s) should also attend. The management review process must ensure that the necessary information is collected ahead of time to allow management to effectively carry out an evaluation prior to the meeting. Note taking and action recording is often undertaken by the Management Representative who will forward minutes of the management review meeting to those on the distribution list and to those with actions.

Critical management review agenda items, such as; process performance, customer feedback and monitoring and measuring results should be reviewed monthly, while less critical agenda items, such as reviewing the quality policy and objectives should be undertaken less frequently, perhaps every quarter. This approach minimizes the length of each management review meeting, covers all of the required management review inputs over the duration of the management review programme, and allows for the analysis of trends in data while the information is contemporary. Annual management reviews are insufficient in frequency to be able react to any issues effectively. Performance metrics should be monitored with varying frequencies, some hourly, some daily, some weekly and some monthly. Management cannot wait for six months to respond, if they do, it will be too late. Top management might conduct weekly meetings in which they review metrics and objectives to determine if any corrective action is required. The process owner is then responsible for reporting close out progress in the meeting a week later. Every time management convenes to review and react to performance, it is considered as a management review. Some companies have multiple review levels, whereby, each review may require multiple subjects and rely upon multiple metrics as inputs. Sometimes subjects are reviewed at more than one level, e.g. production numbers might be reviewed by the Production teams during daily production meetings and then by senior management, possibly weekly.