Role of Quality Manager

  1. Quality Standards.  Documents and records are used all throughout the company.  Nobody should know more about quality, compliance and processes than the Quality Manager.  Your experience with Good Manufacturing Practices (GMP), ISO standards (i.e. ISO 9001), or 21 CFR 820 within a regulated industry are important to managing and controlling documents and records.
  2. Quality Project Management.  A Quality Manager is also a project manager managing corrective action, process improvement, and auditing projects.  One must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention to detail helps too.  Perhaps most important of all is understanding the financial – risk-reward – trade-offs in good project management.
  3. Business Process Documentation.  A Quality Manager must be able to understand, comply, and improve established company policies and procedures.  Developing standard work, policies, procedures, job aids, and business process communications are a part of the job.  A Quality Manager is also a technical writer.  Familiarity with policy and procedure writing will help you to succeed.  Technical writing conveys technical information using active voice construction, instructional design, and desktop publishing methods to transfer information into understandable and useful information.
  4. Document Control.  As the Quality Manager, your Knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions is vital to maintaining your company’s compliance program.  A Quality Manager may be the Document Control Manager responsible for organizing documents into an easy to use and fast retrieval system.  Users need their policies and procedures to conform to requirements.  If they cannot find them, then they cannot follow them… Document control is an important priority.
  5. quality managerQuality Communications.  It might go without saying but explaining business process compliance to others is what a Quality Manager has to do.  Being able to understand a variety of instructions furnished in written, oral, diagram, or schedule form helps others to follow and conform to the established best practice.  Communicating compliance and conformance is done using software such as Microsoft Word and Excel, training using PowerPoint, process mapping using Visio, Statistical Process Control (SPC) using statistics, as well as document revision control software for policies and procedures management.
  6. People Management.  A Quality Manager should not be afraid of asking questions, collecting business process information, and working with others in a positive and collaborative manner.  Business processes include sensitive accounting and financial processes too.  So, you must be comfortable speaking effectively and communicating directly with all levels of personnel.
  7. Quality Auditing.  A Quality Manager performs some of the quality audits.  Supply chain audits, process audits, and may even lead ISO audits an act as a Lead Auditor managing teams of auditors.  Clearly understanding the compliance requirements, collecting objective evidence, and writing up audit reports ensure the quality management system is operating effectively.
  8. Problem Solving.  The Quality Manager solves problems, typically in situations where general standardization should exist, but may not be operating effectively.  Using process mapping techniques, lean, or Six Sigma process improvement methodology is essential to reducing waste and being effective in the Quality role.   A delicate balance exists between resolving problems yourself and identifying those situations that require management intervention for a solution.  Good political judgment is required where quality and compliance are concerned.
  9. Team Player.  The Quality Manager is involved in teams and meetings at every level of the organization.  Management reviews, material reviews, supplier reviews, corrective action reviews, process improvement teams, audits, customer visits and strategy discussions.  A good Quality Manager is involved with many areas of the company.
  10. Quality “Go To” Guy.  The Quality Manager is the person that everybody goes to to get answers about quality.  Product specifications, supplier requirements, testing, inspections, part verification, equipment calibration, corrective actions, non-conformances, workers compensation, benchmarking, voice of the customer, and on and on.  The buck stops here at Quality.

 

Source: www.bizmanualz.com

Requirements of Quality Management System

What are Requirements of ISO 9001 Quality Management Systems?

audited image1The ISO offers one among the known management systems within the world. Overall, the systems are enforced by quite one million organizations in many countries. The ISO 9001 certified company follows tips set by the organization. The standards represent the foremost comprehensive existing nowadays, and are a tried and tested framework for firms to higher make sure that they’re meeting the wants of their several purchasers.

Requirements – Documentation

In order to be ISO 9001 compliant, an authorized company giving services or product should be in possession of documented statements of a top quality policy that delineates the standard objectives.

Quality Manual

A company seeking ISO 9001 certification should possess a top ISO 9001 quality manual that sets forth the scope of the standard management system and documented procedures for addressing quality problems.

Control of Documentation

Documentation should be controlled therefore on make sure the documents are approved before being issued. Additionally, all documentation should be unbroken up-to-date. Revisions should be resubmitted for approval once an amendment is formed.

Management Responsibility

Although the ISO 9001 produces the management standards, it’s the responsibility of the corporate to self-audit. Additionally, the corporate might permit customers to perform an audit likewise. To be certified as compliant, businesses management practices should be reviewed by a freelance ISO 9001 quality system certification company.

Measurement and Analysis

Per Section eight of the ISO standards, an organization should set up and implement “the watching, measure, analysis and improvement processes” that are required to demonstrate conformity to product necessities, guarantee conformity of the standard management system, and to supply continual improvement of the standard management necessities.

Continual Improvement

In order to stay compliant with the ISO standards, an organization should frequently develop and improve its own tips to make sure corrective and preventative measures are in situ to contend with any nonconformity that will arise.

source: qms9001certificationprocedures.wordpress.com

Understanding Change in a Quality Culture

Clock with time for change written on itIn any improvement process, managing the influence of change and the anti-change culture that will continually try to raise its head will be one of the most ardent tasks. Learn to deal with this as effectively as you do the project management itself. There are many well-written books on the subject of change in every category of change that you could imagine. Below is a compiled list of items about change that are relevant to implementing process change.

When examining change it is necessary to understand the stages of change that have been identified. It is interesting to note that these stages take place in varying degrees in different people, but are exactly the same whether the change is a different process in the workplace or the death of someone close. You should be able to identify and deal with the levels of acceptance encountered. Here are the stages and some tips on how to deal with them.

Denial

A wonderful self-preservation response. It is characterised by minimising the situation, and saying (or thinking) things like “This isn’t happening”, “It won’t help”, and “There’s no problem.” You may find the person will avoid talking about the situation, or even make up excuses for not attending meetings.

  • Explain the denial to commitment process that you went through to get where you are.
  • Present the situation openly and allow a lot of time for questions and answers.
  • Have a training session on change management.
  • Present a caring and understanding front. Though this may not be your normal attitude, during this process it will be invaluable.
  • Be a broken record with memos, thank you emails, posters, or anything else that presents your platform in a positive light.

Resistance

It is at this stage that you may see the active signs of sabotage. They may be passive, as in “I’ll just do it my way anyway”, along with a lot of whining-crabbing about the new systems. Or they may manifest in physical methods of sabotage depending on the character of the person. Be aware that these are real threats to the success of any project. But for the most part, those who fall into this category will show a lack of interest and a lot of time spent on finding reasons it won’t work.

  • Listen! And I mean listen. You can hear more in the tone and inflection of what is being said as well as the body language than you can imagine.
  • Solicit Response. People love to know that they are being heard and even more that their suggestions are valid. Many of them are. These are the people who will make or break the installation, let them know they have input to the outcome.
  • Acknowledge Feelings. Let them know you went through a similar process in getting where you are. Validate that they are not alone.

Exploration

People will begin to see some of the good that may occur in the situation, and will generally vacillate between thinking that it might be ok and that it is still a bad idea. But, the up side is that you are beginning to get them on your side and they will begin to make effort to get the changes in place.

  • Facilitate. People are more open at this point. Take advantage of it. Be your own commercial! Challenge people to find a better way within the new system. It gets them thinking about the next round of change and off the current.
  • Reward forward thinking with mounds of compliments. Praise the desired behaviour.
  • Seek out new possibilities. Have brainstorming sessions. It does wonders for everyone’s moral.

Commitment

You’ve got buy-in and will see productivity through the changes. People can see the bigger picture and the opportunity that the change affords.

When dealing with this from a management point of view, it is important to remember several things. These feelings are very real and they happen at different times for different areas of the organisation. Do not expect to spend several months agonising over the commitment to purchase expensive software only to turn around and expect everyone else to do a Tarzan swing from denial to commitment in a week. Remember the process you had to get through in order to accept the change. Others will require the same; allow the process to manifest itself in others. You can facilitate the process by understanding it and helping others to get through.

  • Recognise and acknowledge those who get there. Give them more opportunity to improve the process and celebrate their victories.
  • Inspire people to get others on board. Teach them about the process and how to recognise the people in various stages and how to move them along.
  • CELEBRATE!!!!! Most important. When you have achieved goals, let everyone know and celebrate, celebrate, celebrate. When people know their efforts will be recognised and appreciated, you will have fewer problems in future change.

Remember that we have a tremendous amount of information to process every day. There is more information in a single daily paper today than a person in the 15th century processed in a lifetime. Change takes form in one of three types; that which we cannot control, that which we can, and that which we can influence. Being positive and trying to move things from cannot control to can influence helps in the ability to manage the changes that occur. But, there will always be those things you cannot control and acceptance of that fact is the only road to remaining sane.

Source: http://www.projectsmart.co.uk ,  John W. Wright III

Key: Quality Management Plan

The Quality Management Plan defines the acceptable level of quality, which is typically defined by the customer, and describes how the project will ensure this level of quality in its deliverables and work processes. Quality management activities ensure that:

  • Products are built to meet agreed- upon standards and requirements
  • Work processes are performed efficiently and as documented
  • Non-conformances found are identified and appropriate corrective action is taken

quality

Quality Management plans apply to project deliverables and project work processes. Quality control activities monitor and verify that project deliverables meet defined quality standards. Quality assurance activities monitor and verify that the processes used to manage and create the deliverables are followed and are effective.

Quality Plan Components
The Quality Management Plan describes the following quality management components:

  • Quality objectives
  • Key project deliverables and processes to be reviewed for satisfactory quality level
  • Quality standards
  • Quality control and assurance activities
  • Quality roles and responsibilities
  • Quality tools
  • Plan for reporting q uality control and assurance problems

Rationale/Purpose
The purpose of developing a quality plan at the Stage 3 level is to elicit the customer’s expectations in terms of quality and prepare a proactive quality management plan to meet those expectations.

The Quality Management Plan helps the project manager determine if deliverables are being produced to an acceptable quality level and if the project processes used to manage and create the deliverables are effective and properly applied.

Who is involved
Project Manager
Project Team
Customer
Project Sponsor

Result
Quality Management Plan segment of the Project Plan

Objectives of Quality Management System Certification

Objectives of Quality Management System Certification

ISO 9001(1)1QMS standard may be a set of quality management tips that are adopted by thousands of organizations round the world. It provides processes and procedures to assist corporations improve the standard of the merchandise or service they supply. So as to attain ISO accreditation, businesses have to be compelled to demonstrate to meet variety of objectives for effective QMS implementation.

Senior Management Commitment

Effective Quality Management System requires that the complete commitment and backing of senior management may be a very important component of achieving ISO accreditation. While not the complete support of the senior management team, the creation and implementation of quality management systems and processes can lack the impetus needed to form them winning. This will increase the chance that any enforced procedures will quickly fail, so compromising quality.


Design Process

ISO 9001 states that everyone comes should be planned completely and with quality as a priority in any respect stages within the life cycle of the merchandise, from style to manufacture to maintenance. Any changes or alterations within the style of the merchandise have to be compelled to be QMS 9001 documentation and recorded, and therefore the data of the amendment communicated to any or all relevant parties.


Supplier Vetting

It may be requirements of QMS 9001 that every one new supplier is completely vetted before any contracts are awarded. This is to determine the standard of service and products that the provider can give; similarly as guaranteeing that they need the resources necessary to satisfy your demand. This can lead to long and productive operating relationships with suppliers.


Inspection and Testing

All materials and product utilized in the creation and producing of an item should be completely inspected before use. This is often to confirm that they’re fit purpose, and every one testing records should be maintained and filed. Before a product is free to the general public, it should endure final testing and attain the sign-off of senior management.

Internal Audits

All businesses seeking QMS certification should do regular and thorough internal audits to check that the processes and procedures that are enforced among the corporate are operating and being well maintained. Any shortcomings, discrepancies or areas of improvement should be communicated to senior management and a point in time given for any issues to be corrected.

Steps involved in ISO9001:2008 Certification

Steps involved in ISO9001:2008 Certification 

ISO 9001
The steps involved in any ISO9000 certification project are the following:

  • Gap Analysis: Assessment of existing quality management practices vis-a-vis ISO9001 requirements.
  • Orientation Training: Top/Senior Management orientation on ISO9001 requirements and action plans.
  • System Documentation: Preparation of quality manuals and design of quality record formats.
  • System Implementation: Implementation of quality system as per the quality manuals.
  • Company-wide Training: Training on ISO9000 clauses, Statistical Quality Control Techniques, and Quality Audit.
  • Internal Quality Audits: Periodic assessment of quality system implementation and corrective actions.
  • Pre assessment: Initial audit by Certifying agency, and, implementation of corrective actions.
  • Final Assessment: Certification audit by the Certifying agency and recommendation for certification

Total Quality Management Strategies: Advantages & Disadvantages

Total Quality Management Strategies: Advantages & Disadvantages

Total Quality Management is a system of continuous improvement that involves all workers in a business from upper management to production line workers. The focus of the improvement program is to improve customer service and reduce waste in the business. Quality improvement teams use problem-solving techniques and analysis to identify and eliminate weaknesses in the company.
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Production Disruption

Implementing a Total Quality Management system in a company requires extensive training of employees. The employee training includes instruction in problem solving techniques and the tools to evaluate a process and identify weaknesses such as statistical process control, Pareto diagrams and brainstorming techniques. During the initial training period, productivity can decline. Meetings for quality improvement teams also take workers away from their duties, which also reduce productivity. While the improvements do reduce lead time, eliminate waste and improve productivity, the beginning stages of implementing Total Quality Management in an organization can reduce worker output.

Lowers Production Costs

A Total Quality Management program eliminates defects and waste, which reduces production costs in a business. As teams gather to identify and eliminate weaknesses in the business, the company continues to enjoy reduced costs and higher profit. Quality improvement teams can eliminate defects, reduce lead time and identify redundancies in the production process that can significantly add to the profit the company earns.

Employee Resistance

Total Quality Management requires change in mindset, attitude and methods for performing their jobs. When management does not effectively communicate the team approach of Total Quality Management, workers may become fearful, which leads to employee resistance. When workers resist the program, it can lower employee morale and productivity for the business. Total Quality Management uses small incremental improvements to move the business forward. It can take years for a company to enjoy the benefits of the program.

Employee Participation

Once workers understand their participation and involvement in Total Quality Management is essential to its success, morale and productivity improve. Workers become empowered through participation on quality improvement teams. Businesses can improve morale further by recognizing improvement teams that make meaningful changes in the production process to reduce or eliminate waste.

source: http://smallbusiness.chron.com  by  Luanne Kelchner, Demand Media

Continuous Improvement – Way of Developing New Products

Continuous Improvement – Way of Developing New Products

Many companies pursuing lean transformation and continuous improvement are focusing on the customer fulfillment operations to improve quality and delivery while reducing costs.

future

Organizations are working to reduce lead time, improve quality, and make their manufacturing and distribution operations more efficient in an effort to cut costs. While these improvements are important, they are not sufficient in today’s globally competitive manufacturing world.

In many companies today, direct labor is a single-digit percentage of the cost of goods sold (COGS), with purchased materials and overhead burden making up over 90% of their COGS. Even with these cost breakdowns, many continuous improvement efforts still focus on trying to eliminate waste in the manufacturing process to use labor more efficiently to reduce labor content. These efforts will produce some small incremental improvements in the COGS, but a much better opportunity exists early in the new product design cycle.

It is estimated by some product development experts that 80% of the final cost of a new product is determined in the first 20% of the design cycle where the product concept and initial design philosophy are chosen. If you involve your manufacturing organization and your suppliers at these very early stages of the cycle and form a concurrent engineering design team, you have the opportunity to design products for manufacturing and assembly, both at your suppliers and in your own operations as well as using their expertise in your designs. Using such design-for-manufacturing techniques as reduced parts count, substitution of molded plastics or pressed and sintered powdered metal parts for machined metal and poka-yoke designs to eliminate assembly errors, your new products can be developed with a radically lower final cost of goods sold.

People from your manufacturing operations are a great resource to use with your product design teams to offer suggestions on how designs can be manufactured and how costs can be reduced by making products easier to assemble, with less chance for quality issues and their resultant scrap and rework costs. Manufacturing engineers can plan how to produce a new product while it’s still in design when options for processing methods and equipment are still available. Operators can evaluate their ability to assemble new products and can offer suggestions on visibility and accessibility of components before designs are frozen.

Manufacturing personnel who are familiar with existing products can suggest part substitutions to increase commonality of parts rather than having all unique components. A unique fastener that is out of stock will shut down a product operation just as surely as a custom casting or machined component, but common fasteners can often be designed in from the start.

Your suppliers, working with your product development teams, can suggest design alternatives that often reduce a product’s material cost by up to 50%. Rather than just giving them a component specification to quote, use their expertise to suggest alternate materials, design options, different fabrication techniques, and tolerances that really matter to reduce your product’s component costs. Too often, suppliers are not trusted and not involved until the design is complete and your organization has lost the opportunity to exploit the supplier’s expertise to minimize component costs by being involved with the design team from the very beginning.

There are a number of organizations utilizing concurrent engineering design teams today to incorporate the knowledge and unique experience of suppliers, manufacturing engineers, quality professionals, production and distribution personnel, accounting/finance folks and marketing/sales people to bring increased knowledge and expertise to the team to get better designs at a lower product cost. These teams are part of the design process from the very beginning, at the ideation phase, to develop new products that are better quality and lower cost than those designed exclusively behind the curtain of new-product engineering. Don’t forget to involve your suppliers and operations organization in your new product-development process at the very start.

source: http://www.industryweek.com

Revised ISO 9001 Standard Moves Closer to Completion

Revised ISO 9001 Standard Moves Closer to Completion

The revised standard will retain its strong focus on a process-based approach to quality management systems.

quality management

There is change afoot with respect to the ISO 9001 standard on quality management systems.

It is not unexpected change. All ISO standards are reviewed every three to five years to determine whether revisions are needed to keep the standards current and relevant in the marketplace, according to the International Organization for Standardization.

ISO 9001 is in the late stages of the revision process, with a new edition expected in 2015.

There are several changes outlined in the ISO 9001: 2015 edition, although the standard will retain its strong focus on a process-based approach to produce desired outcomes, explained Nigel Croft, chair of the ISO subcommittee revising the standard, in a Web update. “…which in the case of a quality management systems means, of course, consistent products and services consistently meeting customer needs and expectations.”

The changes focus on three concepts:

  1. The process approach will strongly emphasize that the quality management system has to be woven into and fully aligned with an organization’s strategic direction.
  2. Superimposed on the system of processes is the PDCA (plan-do-check-act) methodology, which will apply both to individual processes as well as the quality management system as a whole.
  3. An overall focus on risk-based thinking aimed at “preventing undesirable outcomes,” such as non-conforming products and services.

A recent vote approved the latest draft of the revised ISO 9001 standard, which has since moved to the next stage – Final Draft International Standard. In his update, Croft explained that the subcommittee will review comments that came in during the last vote and produce a final draft, which then will be voted on.

While ISO itself does not certify organizations to ISO standards, Croft noted that there would be a three-year transition period for companies to migrate to the updated standard once the new edition is published.

He also suggested that organizations may want to review the draft rather than wait until the new edition of the standard is published.

https://www.youtube.com/watch?v=1JIMyvpP0tw#t=319

Source: http://www.industryweek.com

Internal Auditing – How Often ?

Any organisation/business is required to conduct internal audits to maintain its ISO9001 standard. The audit involves testing out company processes and procedures to determine the standard at which they operate when compared to how they should work. Audits are designed to help employees but the mere mention of the word can see your staff sent into a panic, scrambling around to make everything look perfect. However, communicating yourself well to your staff on the benefit of the audits, and letting them know that this is not a finger pointing exercise, can serve well to make these audits more positive.

Internal audits should be viewed in a positive light, a chance to take a step back and have your process reviewed by a fresh set of objective eyes. They are an ideal way to prepare for external assessment too. In some ways internal assessments can be more thorough as processes are examined more closely, more frequently and in greater detail than external auditors.

ISO 9001 does not specify how often internal audits should be conducted. Instead, the requirements are that organisations audit based on how important a process is, the risks involved and whether there is an existing record of previous concerns. Consideration should also be given to quality objectives as these can dictate audit frequency. At the least, internal audits should be carried out annually. There are two ways around this – auditors may decide to review processes in one go, or they may portion off aspects and have a plan which details the schedule over a number of months. Complex processes may require more frequent assessment and this should be built into an internal audit plan.

The audit plan removes the need for panic and helps eliminate an atmosphere of mistrust. It lets everyone know what will be happening and when, as well as allowing process owners time to complete any improvements that may be taking place. Although the audit plan is made general knowledge, the detail relating to timings should be confirmed with respective process owners as soon as is possible.

The internal audit should not be seen as second string to an external audit and for that reason it needs to be as thorough as possible. Appointed auditors may benefit from some training and development to support them in getting the best out of the process. Auditors should apply a variety of methods to test the process including talking to employees, reviewing data and relevant documentation as well as and perhaps most importantly observing the process in practice. Part of being thorough is keeping accurate documentation that is a true reflection of the findings, for both management and future audits.

The aim of the audit should not be to purely report non-conformance, but auditors should also use the opportunity to highlight areas of a process which may benefit from change. Therefore as important as the audit is the follow up. Follow ups are critical to ensuring that the audit cycle is closed off, and they are also a great motivating factor for further improvements.

source: http://synergosconsultancy.co.uk
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