quality management system management review

QUALITY MANAGEMENT SYSTEM

MANAGEMENT REVIEW

Document No.: QP-11

Abstract

This process establishes a procedure to ensure the quality management system’s continuing suitability, adequacy and effectiveness. The reviews include assessing opportunities for improvement and need for changes to the quality management system, including policies and objectives.

DOCUMENT REVIEW, APPROVAL AND REVISION

Approved by: Reviewed by:

Revision: 5

General Manager

QA/QC Manager Revision Date: May 24, 2018

Note: Uncontrolled document when printed.

مكتب الحمـــدان الإستشـــــاري

Al-Hamdan Consulting Office

AL-HAMDAN CONSULTING OFFICE - QUALITY MANAGEMENT SYSTEM

Title: MANAGE MANAGEMENT REVIEW

Doc No.: QP-11 Rev No.: 5 Date: May 24, 2018 Page: 2 of 16

REVISION HISTORY REV NO REV DATE DETAIL DESCRIPTION OF CHANGE Page Para

0 July 30, 2011 Nil Nil Initial Issue for Implementation.

1 April 03, 2012 3 8

1 1

1.1 Purpose is revised according to requirements. 1.2 Word IMPACT is added.

2 Oct 1, 2013 5,6 5

5.2

Changed all references of Office Manager (OM) to General Manager (GM). Management review meeting frequency changed.

3 May 1, 2014 QHSEM is changed to QHSEMR and other minor changes.

4 Jan 25, 2018 ALL ALL Procedure upgraded, Changed all references of QHSEMR to QA/QC Manager

5 May 24, 2018 Upgraded as per recommendation of Consultant (TUV Nord), Changed all references of IMS to QMS




1. POLICY:

Top Management shall meet periodically to review the organization Quality Management System (QMS) to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.

2. PURPOSE:

To collect timely feedback on the performance and effectiveness of the QMS, determine and select opportunity for improvement, implement any necessary actions to meet customer requirements and enhance customer satisfaction.

To ensure that the Quality Management System as described in Quality Management System Manual and operating procedures is effective and is fully complying with the requirements of related applied ISO standards, its Policies and Objectives.

3. SCOPE:

This process covers all functional areas of HCO where activities are controlled by QMS and applies to Top Management, Quality Management and all other managers involved with QMS.

4. DEFINITION AND ACRONYMS:

Management Team - consist of Top Management Department (Chairman, General Manager, Commercial Manager, HR & Admin Manager and QA/QC Manager).

Top Management – Generally, a group of company officers (Chairman, General Manager, Commercial Manager, HR & Admin Manager and QA/QC Manager) with primary responsibility for decisions and activities affecting the long term (e.g. strategic planning); may also be referred to as “Senior Level Management”.

CAR - Corrective Action Report documents steps taken to permanently resolve non-conformities.

Quality Policy - Overall intentions and directions of HCO related to quality as formally expressed by Top Management.

Quality Management System Objectives - Something sought, or aimed for, related to Quality Management System (quality, environment, OH&S, Food

Safety, and Information Security).

Continual Improvement - Recurring activity to increase the ability to fulfill requirements.

Effectiveness - Extent to which planned activities are realized and planned results achieved.




Efficiency - Relationship between the result achieved and resources used.

5. RESPONSIBILITIES:

Top Managements are responsible for effective implementation of this procedure, as well as for the suitability, adequacy and effectiveness of the entire QMS. Top Management shall conduct Management Review Meeting twice a year or at least once in each fiscal year. This is responsibility of Top Management to ensure that the recommendations in management review meeting should be implemented as appropriate.

Department Managers are responsible for providing information action item status, overall QMS performance and their respective process performance and effectiveness.

QA/QC Manager is responsible for reporting Top Management on the performance of the QMS and any need for improvement.

6. RISK ASSESSMENT:

One of the biggest risks to the inability to meet strategic and quality objectives is the inadequate management of change. Change needs to be a key topic in Management Review Meeting. Example:

• IT Changes • Product Changes • Market Changes • Organization Changes • Process/Equipment Changes • Facility Changes • Regulatory Changes

7. DESCRIPTION OF ACTIVITIES:

7.1. Management Review Process Flowchart




1- Schedule Review

2- Prepare & Submit Agenda

4- Meeting Result

5- Action Implementation

3- Conduct Meeting

Agenda

Minutes Decisions CPAs




ANNUAL MANAGEMENT REVIEW PROCESS:




Management Review Meeting:

ID Activity Responsibility Key Points Critical Control Point Reference Doc. No. 1 Schedule System

Management Review Meetings

QA/QC MANAGER

1. Management review may be held twice a year or least once in each fiscal year

2. Schedule is forward to Top Management 3. Annual Review shall encompass all applicable aspects

of Quality Management System.

Top Management members shall receive the Management Review Meeting schedule.

QA/QC Manager ensures the presence of all Top Management during the Management Review Meeting.

FM:QR:01

2 Prepare & Submit Management Review Agenda

QA/QC MANAGER

1. Prepares, Issues Review Agenda & supporting materials.

2. Agenda & supporting documents to be issued at least one week in advance of Management Review Meeting.

Agenda shall include information on:

1. Follow up actions from previous management review meetings.

2. Changes to internal and external issues that are relevant to the Quality Management System

3. Strategic objective 4. Processes Performance 5. Business Trends 6. Resources required 7. Results of Internal Audits/External Audit. 8. Customer Satisfaction and Feedback 9. Non-Conformities and Corrective Action 10. Business Improvement Actions

FM:QR:02

3 Conduct Management Review Meeting

TOP MANAGEMENT

1. Conduct meeting in accordance with agenda. Top Management shall attend the Management Review Meeting.

4 Management Review Meeting output

TOP MANAGEMENT

1. Records the decision taken, CARs and resources required.

1. Review output shall include: a. System Improvement Initiatives. b. Strategic Objectives amendment c. Change of quality policy and objectives, d. plans and possible actions for

improvements, e. change of resources,

FM:QM:04




f. business plans, g. budgets h. Resources Action plan

5 Action Implementation:

Issue meeting minutes & CARs for implementation.

TOP MANAGEMENT

1. Minutes of review are issued to Top Management within 5 working days.

2. Minutes of review and CARs are issued to those who are assigned for implementation.

1. CARs shall be accurately documented. 2. CARs shall address Root Cause and assign

to right person for analysis and action implementation.

QP-04

8. REFERENCE:

8.1. Quality Management System Manual, Clause 9.3

8.2. ISO 9001:2015, Clause 9.3

9. ASSOCIATED DOCUMENTS:

S/N Document no. Document Title 9.1 QP-03 Internal Audits 9.2 QP-04 Control of Non-Conforming Products and Corrective Action 9.3 FM:QR:01 Management Review Agenda 9.4 FM:QR:02 Management Review Minutes 9.5 FM:QM:04 Non-Conformity and Corrective Action Request




10. RECORD RETENTION TABLE:

Identification Storage Retention Disposition Protection

FM:QR:01 Quality Management

Office 5 Years

Shredding / delete electronic copies from system

Secured office / electronic Backup

FM:QR:02 Quality Management

Office 5 Years

FM:QM:04 Quality Management

Office 5 Years

9. APPENDICES:

9.1. Problem Solving Process

9.2. Groupthink

9.3. Crucial Decisions Making Common Mistakes

9.4. Ethical Decision Making Process




Appendix 9.1 Problem Solving Process Recognize the problem and state it clearly

• Define problems according to the "gaps" between planned objectives and reality, between what should be and what is.

Determine the significance/ impact of the problem

• Managers should focus their attention on significant problems rather than trivial ones. Pareto's Law states that 20 percent of the problems affect 80 percent of the results and vice versa.

• The board should consider the following factors when determining the significance of a problem:

• Control: How much control does the group have over the problem and its solution?

• Importance: How serious or urgent is the problem?

• Difficulty: How difficult will it be to work through the problem to the solution?

• Time: How long will it take to solve the problem?

• Payoff: What is the expected return from solving the problem?

• Resources: How accessible are the resources required to solve the problem?

• In assessing the significance of a problem, the board should ask itself, "Does knowledge of this problem compel us to change past decisions, current operations, or future plans?" An affirmative answer suggests significance

Gather data and information relevant to the conditions associated with the problem; identify possible causes of the problem

Generate criteria for and develop alternative solutions

• Potential solutions for addressing the underlying causes can be generated using logic, intuition, or both.

Evaluate the alternative solutions, and choose from among them

• Potential solutions should be evaluated within the constraints imposed by the board, including the board's attitude toward risk. Sometimes risk is unavoidable because the data that an board needs for a good decision are not available. In this case, the board should document the effect that the uncertainty has on the decision, so that this can play a role in evaluating the solution.

Plan, implement, monitor, and evaluate the selected alternative(s); determine if the problem still exists, and decide on future action




Appendix 9.2 Groupthink What is Groupthink

• A mode of thinking that people engage in when they are deeply involved in a cohesive in-group, when the members' strivings for unanimity override their motivation to realistically appraise alternative courses of action. It refers to a deterioration of mental efficiency, reality testing, and moral judgment that results from in-group pressures.

• Groupthink can lead to bad judgments and decisions being made. It serves as a simple way to deal with difficult issues.

Negative Outcomes

• Superficial examination of the drawbacks of the chosen course

• Examining few alternatives

• Being highly selective in gathering information

• Not having contingency plans

Main Symptoms of Groupthink

• Illusion of Invulnerability: Members ignore obvious danger, take extreme risk, and are overly optimistic.

• Collective Rationalization: Members discredit and explain away warning contrary to group thinking.

• Illusion of Morality: Members believe their decisions are morally correct, ignoring the ethical consequences of their decisions.

• Excessive Stereotyping: The group constructs negative stereotypes of rivals outside the group.

• Pressure for Conformity: Members pressure any in the group who express arguments against the group's stereotypes, illusions, or commitments, viewing such opposition as disloyalty.

• Self-Censorship: Members withhold their dissenting views and counter-arguments.

• Illusion of Unanimity: Members perceive falsely that everyone agrees with the group's decision; silence is seen as consent.

• Mind-Guards: Some members appoint themselves to the role of protecting the group from adverse information that might threaten group complacency.




Avoiding Group Think

• The leader should be neutral when assigning a decision-making task to a group, initially withholding all preferences and expectations. This practice will be especially effective if the leader consistently encourages an atmosphere of open inquiry.

• The leader should give high priority to airing objections and doubts, and be accepting of criticism.

• Groups should always consider unpopular alternatives, assigning the role of devil's advocate to several strong members of the group.

• Spend a sizable amount of time surveying all warning signals from group.

• After reaching a preliminary consensus on a decision, all residual doubts should be expressed and the matter reconsidered.

• Holding a "second-chance meeting" to offer one last opportunity to choose another course of action.




Appendix 9.3 Crucial Decisions Making Common Mistakes

• Plunging in: Gathering information and reaching conclusions without thinking about the crux of the issue or how decisions like this one should be made.

• Frame blindness: Setting out to solve the wrong problem because your framework causes you to overlook attractive options or lose sight of important objectives.

• Lack of frame control: Failing to define the problem in more ways than one, or being unduly influenced by the frames of others

• Overconfidence in your judgment: Failing to collect key factual information because of overconfidence in your assumptions and opinions

• Shortsighted shortcuts: Relying on ‘rules of thumb’ for crucial decisions, or on the most readily available information

• Shooting from the hip: Trying to keep straight in your head all the information relating to the decision rather than relying on a systematic procedure

• Group failure: Assuming that a group of smart people will automatically make a good decision even without a good decision process

• Fooling yourself about feedback: Failing to learn from evidence of past outcomes either because you are protecting your ego or because you are tricked by

hindsight

• Not keeping track: Assuming that experience will make lessons available automatically

• Failure to audit your decision process: Failing to create an organized approach to understanding your own decision process




Appendix 9.4 Ethical Decisions Making Process

• Here are a few key points regarding ethical decisions.

• Responsible practice requires that you:

• base your actions on informed, sound, and responsible judgment

• consult with colleagues or seek supervision

• keep your knowledge and skills current

• engage in a continual process of self-examination

• remain open

• In making ethical decisions, as much as possible and when appropriate, include your client in this ethical decision-making process.

• Clients need enough information about the therapeutic process to be able to make informed choices.

• The informed consent process begins with the intake interview and continues for the duration of the therapeutic relationship.

• Eight Steps in Making Ethical Decisions

Ethical decision making should be a collaborative process between client and counselor, rather than a counselor making decisions. Below are the steps, with suggested questions, to assist you in thinking through an ethical dilemma. This is one of several decision-making models which can be utilized. The steps taken may not always follow the same order shown and steps may be repeated several times in the process.

1. Identify the problem or dilemma.

• Does a problem or dilemma actually exist?

• Is this an ethical, legal, moral, professional, or clinical problem?

• Is it a combination of more than one of these?

• How can you know the nature of the problem?

• Would you consult at this early stage as you are identifying the problem?

• How might you begin the process of consultation with your client about the nature of the problem?




2. Identify the potential issues involved.

• How might you best evaluate the rights, responsibilities, and welfare of all those involved and those who are affected by the decision, including your own welfare as a practitioner?

• How can you best promote your client's independence and self-determination?

• What actions have the least chance of bringing harm to your client?

• What decision will best safeguard the client's welfare?

• How can you create a trusting and collaborative climate where your clients can find their own answers?

• What principles can you use in prioritizing the potential issues involved in this situation?

• Are there any ways to encourage the client to participate in identifying and determining potential ethical issues?

3. Review the relevant ethical codes.

• What guidance can you find on the specific problem under review by consulting with the professional codes?

• Are your values in agreement with the specific ethical code in question?

• How clear and specific are the codes on the specific area under consideration?

• Are the codes consistent with applicable state laws?

4. Know the applicable laws and regulations.

• Are there any laws or regulations that have a bearing on the situation under consideration?

• What are the specific and relevant state and federal laws that apply to the ethical dilemma?

• What are the rules, regulations, and policies of the agency or institution where you work?

5. Obtain consultation.

• Do you know where to go to obtain consultation with professionals who are knowledgeable about ethical issues?

• Assuming that you will consult with a colleague or a supervisor, what would you expect from this consultation?

• What kinds of questions do you want to ask of those with whom you consult?

• With whom do you seek consultation? Do you consult only with those who share your orientation, or do you look for consultants with




different perspectives?

• How can you use the consultation process as an opportunity to test the justification of a course of action you are inclined to take?

• What kinds of information do you document when you consult?

• When you do make use of a consultation process, do you inform your client about this? Are there any ways you might include the client in this consultation process?

6. Consider possible and probable courses of action.

• What are some ways that you can brainstorm many possible courses of action?

• Do you have a systematic method for analyzing ethical obligations and possible courses of action?

• Are you willing to involve your client in the discussion of the various courses of action?

• What might you document pertaining to discussions with your client about probable courses of action?

7. Enumerate the consequences of various decisions.

• How can you best evaluate the potential consequences of each course of action, before implementing a particular action plan?

• Are you willing to involve your client in the discussion of the implications of each course of action for the client?

• What ethical principles can you use as a framework for evaluating the consequences of a given course of action?

• Examine the consequences of various decisions for your client, for you as counselor, and for the profession in general.

8. Decide on what appears to be the best course of action.

• After carefully considering all the information you have gathered, how do you know what seems to be the best action to take?

• Do you solicit the input of your client in making this decision at this phase?

• Once you have formulated a plan of action, do you ask for feedback from a colleague or supervisor?

• Once the course of action has been implemented, what are some ways that you might evaluate the course of action?

• Are you willing to follow up to determine the outcomes and see if further action is necessary?

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