Tip - Management reviews can also decide to simplify or remove processes. This is a valuable but often neglected function of the management review. Use the review to simplify and streamline the QMS.
•Tip - Documented information, e.g. management review minutes, needs to be retained to show that a management review has taken place and that the results have been implemented.
Whilst ISO 9001 does not specify the frequency of management reviews, it is good practice that they should take place at no less than 6 monthly intervals, i.e. 2 per year.
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Integrity Supporting Processes
Michael Guy Deighton, in Facility Integrity Management, 2016
7.6 Management Review
One of the critical success factors of the FIEM is the structured approach to the Plan – Do – Check – Act, or Shewhart cycle, and in particular the feedback loop [check and act]. Each element that makes up the FIEM should be continually reviewed, with deficiencies addressed and improvements made. This ensures that the FIEM elements constantly operate at the highest performance level.
In this light, regular management reviews are required and executed to assess the performance of each of the FIEM elements to drive towards integrity excellence [Figure 7.8]. Management reviews are usually carried out on an annual basis, given the large volume of work required to review each of the ten essential FIEM elements over the year.
Figure 7.8. Supporting processes: Management review.
The output of the management review is kept as a record and used as a benchmark to track improvements made in each of the FIEM elements. The output is also used to update best practice and procedures employed within the facility organization. The management review also ensures that any performance gaps or deficiencies are identified and action owners are assigned to close them.
The Facilities Integrity Excellence Model elements that are reviewed are given in Table 7.1.
Table 7.1. Facility integrity excellence model elements reviewed
No.FIEM Element1Facility Integrity and Reliability2Maintenance Management3Operations4Management of Change5Quality Assurance and Auditing6Incident Reporting7Management of Knowledge8Management Review9Competence10The Facility Integrity Organization
It is also worthwhile to develop the score card to include metrics that can incorporate the extent to which risk-centered culture has been implemented within the facility organization population. This may be achieved by carrying out a detailed questionnaire and/or interviews with key a cross section of the facility integrity organisation. The management review is executed by the senior facility management team and may include a third-party company executive within the review team who is not familiar with the facility. The review team should be kept to a relatively small number of people in order to be effective.
7.6.1 The Management Review Approach
The management review is an extensive review that may take several days to complete properly. There are a number of ways to go about conducting the review. The following approach provides some guidelines:
•Define the scope of the Management Review within the Facility. This may include a particular cross section of a facility process area, or a particular functional group;
•Review the appropriate facility information as provided by the facility groups;
•Conduct a site survey and make observations based on the ongoing and historic maintenance work in the area;
•Assess and note the condition of the facility equipment;
•Interview a sample cross-section of facility personnel from the population;
•Review recent integrity audit reports and check historic audit performance and status of the audit actions;
•Review the FIEM procedures and processes for completeness and extent of implementation;
•Prepare a report to detail the findings and conclusions, ensure the feedback is presented back to the facility organisation teams and acted on.
Ahead of the review, the facility group leaders should prepare a documentation pack that includes details of the subject of the management review, such as historic trending of reliability performance, near misses, availability of the facility, etc. The facility management team should also assign appropriate representation during the site survey, typically an experienced operator and maintenance technician to accompany the management review team in order to guide the team during the review.
During the review, detailed score cards for each of the Facility Integrity Excellence Model elements should be completed. The scoring of each of the elements should be tailored to meet the requirements of each facility.
The individual FIEM element score cards are then rolled up into an overview FIEM score card. Each FIEM element is given an overall summary score and presented in a concise score card template. The score may roll up to a percentage or a total figure, but it is important that the range is the same for all of the FIEM elements in order to compare them going forward. The template may be presented in many ways. An illustration of a typical radar chart that provides a score for each of the FIEM elements is shown in Figure 7.9. This version of the score card shows an array of the FIEM element scores superimposed over the model graphic.
Figure 7.9. FIEM management review score card.
One of the main advantages of employing a radar chart in this process is so that future management reviews can also be superimposed on the same chart. With this method it is possible to compare progress during each management review and physically see improvements being made in certain areas. An example is shown in Figure 7.10.
Figure 7.10. FIEM management review score card 2.
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Reporting
George Ellis, in Project Management in Product Development, 2016
11.1.2 The Content of Your Presentation
This section will present the major items you will want to include in your presentation. If the content is prescribed by your company, follow that format and add detail where appropriate. Of course, every organization is different—augment the list here to meet the needs of yours.
Financial Return
Most management reviews will have focus on financial return, especially early in the project life. Some organizations use complex calculations such as net present value [NPV], return on investment, and breakeven time [Section 5.3.1]. Others focus on more concrete measures such as top-line revenue, margin, or operating profit in the first year or two.
Progress and Milestones
Schedule is normally the main concern of management teams for ongoing projects because of two reasons. First, delay affects profitability strongly [see Section 5.3.2]. Second, delay is a reliable [if lagging] proxy of project health; problems—risks, issues, quality defects, scope creep, customer dissatisfaction—usually result in turnbacks, and turnbacks eventually translate to delay. As discussed in Chapters 5–8Chapter 5Chapter 6Chapter 7Chapter 8, reporting progress [fever or run charts] and milestones [deliverables charts] gives a balanced view of performance to schedule.
Recent Achievements/Upcoming Activities
It’s good to have a short presentation of what’s been accomplished since the last review and what’s expected before the next. However, keep the technical detail at an appropriate level for the audience.
Resource Consumption and Gaps
Review the people and expense being consumed by the project. Your organization probably has standard processes for financial accounting. You may be required to present a balance sheet, showing what was expected for the month versus what was spent; in this case, be prepared to explain surprises. Similarly, your organization may require team members to clock time in the project so that the PM can balance estimated requirements for people time against actual use. If your organization has no requirements here, you still may want to present this type of information, especially if you have identified a gap. If your project plan shows two industrial engineers were committed at the start and you can show you need two industrial engineers to avoid delay, you’re more likely to get those engineers. Simply saying, “I need two industrial engineers to avoid a delay” is less convincing. Every project manager can say, “give me more resources and I’ll get more done,” so bring some data to the discussion.
Risks and Issues
Normally it’s good to present a high-level view of the risk list [see Table 9.4]. Presenting the entire risk list is usually too much detail. Some areas you could present in your review are:
•Details of the largest unresolved risks and issues.
•Details of new significant risks and issues.
•A summary of the total risk list with metrics that show open risks [backlog] and how well risks are being resolved [flow]. For example, you might present a simple balance sheet such as shown in Table 11.1.
Table 11.1. Sample Risk/Issue Balance Sheet
Risks/IssuesHigh ConcernMedium and Low ConcernTotal Risk ListAt start of month41620Added this month+1+3+4Retired this month Planned−2−7−9 Actual−1−7−8At end of month41216
Customer Activity
Your leadership team will usually have a keen eye for understanding progress with customers, either potential large customers or customers that indicate the likelihood of success in a general market. For example, you can speak to how well the value proposition has been validated [Section 9.3.3], early orders, or results of prototype testing. Happy customers create confidence in the project.
Organizational Issues
Does the team need help from anywhere in the organization? Does the test lab schedule threaten to delay the project? Does the team need sourcing to dedicate a resource for a few weeks so material can be ordered? Do you need time from the machine shop or assembly line to build prototypes? The steering committee is often in the best position to help with cross-department resourcing. Of course, no surprises—tell your colleagues in the other departments of your plans well ahead.
Approvals
Does the team need approvals for purchase orders, extra resources, capital requests, and milestone completion? Be ready to explain why the approval is needed. Also, be clear about when it’s needed, for example, “we need $40k to upgrade Line 11; no delays in project anticipated if approval received by May 3.”
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Internal quality audits: A strong tool for quality management
B. Purushothama, in Effective Implementation of Quality Management Systems, 2010
4.5 Top management review versus quality audits
The top management reviews the performance on a regular basis to understand whether the activities are carried out as per the plan. They base their reviews on certain control points and check points, which they feel important. This is also called management by exception. The effectivity depends on the capability of the top man. As the same person reviews the activities, there are chances of bias getting developed, and might not be able to see the deviations. In case of internal quality audits, different auditors from different sections conduct audits, and hence their views are different. They can identify certain vital deviations, which top man cannot identify. The people working observe the top man on a regular basis and identify his likings, disliking and expectations. Moreover, the review frequency and the timings are almost fixed and people try to project only those points which are liked by the top man. By this, some vital deviations or drawbacks get camouflaged and go unnoticed. As auditors are unbiased and outsiders, one cannot selectively hide the facts and hence the real deviations are exposed. Actions can be initiated to correct the deviations. The top man, by his involvement and experience, shall be clear about the process and able to identify vital deviations faster. Auditor shall not be able to identify inefficient procedures that are followed, where as an experienced top man with deep knowledge of the process requirements questions the basis of the procedure adopted, and modifies them. An auditor being an outsider cannot suggest any improvement, but can only say that a deviation is found. He doesn’t know whether the deviation found was advantageous or disadvantageous. Table 4.1 gives few differences among quality control, review by top man and internal quality auditing.
Table 4.1. Few differences among quality control, review by top man and internal quality auditing.
Type of monitoringQuality control checksReview by top manInternal quality auditsPlanned/SurpriseSurprise checksPlanned reviewPlanned auditAction taken onDeviations foundDeviations foundOn all aspects in advance, and especially on deviations found.RelationsThe production person always sees QC man as a faultfinder, and hence no team work.Top man is the boss, and hence people down the line hesitate to highlight the mistakes in instructions.Free atmosphere as auditor is a third person, and does not find only faults, but shows the area for improvement. Hence it is teamwork.Action startsAction starts after the deviation is noticed.Action starts after the deviation is noticed.Actions start before deviation is noticed.What is reportedMainly deviationsBoth compliance and deviationsBoth compliance and deviationsCareer developmentNo chancesSlight to the extent the boss educates.Self-learning while auditing the systems of other sections.Improvement chances at the other endNilNilAuditee improves his own systems after seeing good systems at auditee place.AnxietyAnxiety prevails as we do not know what shall be reported by QC man to top person.No anxiety as the boss tells clearly his findings.No anxiety as the auditor discusses with auditee while drafting his report, and while rising nonconformities.ParticipationOnly by the in-charges and the QC investigator.Only by boss and the in-chargesBy all working in the section along with the auditors and the boss.
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Cost of corrosion
Gerhardus Koch, in Trends in Oil and Gas Corrosion Research and Technologies, 2017
1.7.2.13 Management review
A management review is an important aspect of a management system that demonstrates commitment from the organization for implementing, reviewing, and continually improving the management system and associated processes and documents. Management reviews are carried out at the optimized frequency determined by the organization to promote the continuing effectiveness of the CMS, examine current issues, and assess opportunities for improvement.
Typical information inputs for management reviews include:
•Findings from nonconformances, incidents, and failures, both internal and external
•Status of preventive and corrective actions
•Follow-up actions from previous management reviews
•Changes in the organization's operational environment that could affect the CMS including the requirements for additional or revised resources or changes to applicable regulations or standards
•Audit results, both internal and external
•Overall performance in terms of key performance indicators
•Opportunities for improvement
Typical outputs of the management reviews include
•Changes to policy, strategy, or objectives associated with the CMS
•Reallocation or supplementing of resources
•Changing organizational details, including staffing or responsibility updates
•Corrective and preventative measures
•Changes to the CMS processes, procedures, or documents
A process should be implemented to track the completion of any required actions determined during the management review.
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What an Environmental Management System Is All About
Nicholas P. Cheremisinoff Ph.D., Motasem B. Haddadin, in Beyond Compliance, 2006
Clause 4.6
Clause 4.6, Management Review, requires that top management periodically review the overall operation of the EMS and consider changes, including revision of the environmental policy, new environmental objectives and targets, new personnel assignments, and so on throughout the 17 elements of ISO 14001. The management review is central to the continual improvement process, because only top management can authorize changes in the basic structure and operation of the company's EMS.
The main body of information for this review comes from activities carried out under Clause 4.5, Checking and Corrective Action. But, changes in EMS elements may be necessary because of altered external conditions, such as environmental regulations, market preferences, supply chain requirements of a major customer, and the like; so other sources of information have to be called into play as well. Again, while ISO 14001 does not require that the management review cover the actual environmental performance of the company or the business consequences of that performance, enlightened top management also includes these subjects in the review.
ISO 14001 is an international standard for environmental management systems. It is not a standard for environmental performance, and it does not even suggest or imply environmental performance criteria. Conformance to the ISO 14001 standard is voluntary, and the ISO 14001 accreditation and certification mechanisms are [or should be] operated completely without government involvement. In fact, the language of the standard makes clear that it is meant to be applicable to organizations that want to self-declare their conformance with ISO 14001 or demonstrate their conformance to others [like major customers who demand it], as well as to those who seek certification or registration.
Collectively, the ISO 14001 clauses just described are based on the plan-do-check-revise/act management model. Figure 3-2 summarizes the clauses over the continual improvement process.
Figure 3-2. ISO 14001 within the context of the continual improvement process.
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Major US incidents in the twenty-first century
Roy E. Sanders, in Chemical Process Safety [Fourth Edition], 2015
The summary of the Baker Panel findings
The Baker Panel’s technical consultants performed PSM reviews employing a five to six person team at all five US BP refineries during the first half of 2006. During their 2 week site visits, they interviewed key personnel at all levels of those organizations.
The panel’s investigation and report focused on being thorough and “letting the chips fall where they may.” The panel urged BP to take immediate extensive steps to address “instances of a lack of operating discipline, toleration of serious deviations from safe operating practices, and apparent complacency toward serious process safety” at each of the five refinery locations. The panel also urged other similar US companies to rigorously examine and strengthen their own safety cultures [17].
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Measuring maturity in QMS implementation
B. Purushothama, in Effective Implementation of Quality Management Systems, 2010
26 Communicating customer concerns
1
All market complaints are recorded and discussed in the management review meeting.
2All market complaints received are displayed prominently in the work area so that concerned persons can take suitable remedial actions.
3Marketing person visits the customer and brings the feedback and complaint samples and discusses with concerned production and quality personnel.
4Senior managers visit the customer’s place to understand the concerns, and explain the same in an open house to all the staff.
5Production and quality executives visit the customer place, study the working, discuss the concerns with the actual users, and explain the same to the people involved in manufacturing and quality control.
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History, Science and Methods
S.A. Slorach, in Encyclopedia of Food Safety, 2014
Step 4: Monitoring and Review
The fourth, and last, step in the risk management process, monitoring and review, comprises the following activities:
•Monitor the outcomes of the control measures.
•Evaluate the results.
•Review controls if the risk management goals are not achieved.
Monitor the Outcomes of Control Measures
When deciding on the measures to be introduced to tackle a food safety problem, it is important to plan how to monitor the outcome of the control measures. Depending on the problem and the desired outcome, this can include, for example, monitoring the levels of pesticide or veterinary drug residues in specific foods before and after introducing the measures, measuring human exposure to chemical hazards [e.g., PCBs, dioxins, lead] or control of food labeling of especial importance for persons who are allergic or hypersensitive to certain food ingredients. For instance, it is through such a monitoring program that the Irish authorities discovered contamination of pork meat with dioxin in 2008. Such monitoring programs are important for biotoxins and radionuclides.
When the control measures have been aimed at producing improvements in food production processes and handling by food business operators, food inspection should monitor and confirm that the desired improvements have been made.
Where the measures introduced comprise mainly information and recommendations to consumers, this should be followed up by surveys to establish if the message has reached the target group and whether it has resulted in the desired changes in food safety behavior.
Many countries periodically carry out total diet studies to assess the exposure of their population to a range of chemical hazards. Such studies can provide assurance that the food supply is safe from such hazards and can identify problems or potential problems based on time-trends. Total diet studies are considered to be an important management tool for addressing the multitude of potentially toxic chemicals that may be present in food.
Evaluate the Results
The results of monitoring after the introduction of measures to reduce human health risks from chemical hazards in food should be evaluated to see if the desired outcome has been achieved. This is the responsibility of the food safety authorities and the results of the evaluation should be made public.
Review Controls if the Risk Management Goals are not Achieved
If, following the evaluation, it is found that the measures introduced have not achieved the established risk management goals, the controls should be reviewed and possibly intensified. If the controls introduced have been found to be ineffective, then the list of risk management options should be reexamined and other or further measures introduced in order to reach the desired food safety outcomes. In some cases, the risk manager may request that the risk assessment be reviewed in order to take into account the latest science and knowledge.
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Product security governance and regulatory compliance
Arnab Ray, in Cybersecurity for Connected Medical Devices, 2022
Cybersecurity management review
Regular audits are not the only way for evaluating the health of a QMS. Management review is a QMS practice in which metrics of different types are collected and presented to executive management as a means of tracking how well a QMS is meeting its quality objectives. Procedural controls for cybersecurity management review should define the following:
Operational metrics
Example of operational metrics an MDM should track as part of management review for cybersecurity:
•Number of open cybersecurity CAPAs
•Number of cybersecurity Quality Plan activities whose deadlines have expired, but the output deliverables of the activity have not been incorporated into the QMS
•Number of medical devices in postmarket phase that have uncontrolled risk and have not been patched
•For cybersecurity patches for medical devices in the field, the patch adoption rate
Design metrics
Example of design metrics an MDM should track as part of management review for cybersecurity:
•For every medical device, number of cybersecurity system threats that are not mitigated by a primary control in the system cybersecurity risk model
•Number of medical devices that fail to implement, totally or partially, a technical control from the master set of technical controls.