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

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Customer in Defining Quality

The Growing Role of the Customer in Defining Quality

Four key factors drive the intersection of customer and quality:

• The role of quality within an organization

• Integration of goals in strategic planning

• Level of transparency on quality goals and reporting

• How the quality measures are used.

It is clear that many organizations are becoming true partners with their customers in order to maximize the value for both stakeholders. Organizations’ definition of quality, the actual quality processes, and using quality measures to drive performance and culture are all closely tied to customers. Because quality and customers are so closely aligned in successful organizations, the two concepts are intersecting into a customer-centric quality culture.

While manufacturing organizations tend to use mature quality practices—in regards to governance models, availability and use of metrics, quality management frameworks and certifications, and training—do their practices include a focus on the customer? What defines a customer-centric, quality culture and what are the driving factors of its success?

To answer these questions APQC(American Productivity and Quality Center) conducted correlation analysis on data, specifically for the manufacturing industries, from American Society for Quality – The Global Sate of Quality survey conducted by APQC for ASQ. The customer-centric quality culture can be defined by four statements that elucidate the organization’s relationship with its customer around quality:

Most of the survey respondents indicated they agree with the statements. However all cultural attributes were not weighted equally. The emphasis was placed on customer service and product performance, rather than two-way engagement or quality and what it means to the customer.

source: http://www.industryweek.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

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

Management Strategy

Managers and employees alike need to earn the respect of team members, colleagues and company leaders. As we all know, respect is not something that comes automatically with a job title – it must be earned. And it’s not only for the management team; every employee will achieve more success and have more confidence at work when they know they have earned the respect of their colleagues.

consulting

Here are a few guiding principles to earn respect, and build success, at work.

Listen to Your Inner Voice – Each of us makes decisions based on our personal compass of what is good or bad, right or wrong, fair or unfair. Particularly while practicing Human Resources, it seems like there are so many rules, there must be one for every situation! But more often than not, we are interpreting the law and also doing the right thing. This is where a strong moral compass is one of the best tools in your management belt.

Wait 24 Hours… Sometimes – Today we are so connected through technology and our work demands quick responses. When considering options or weighty decisions, remember you (and others impacted) will have to live with the decision much longer than it takes to make it. Although we all have to be ready to turn on a dime sometimes, do not underestimate the power of thoughtfulness.

Pick Your Battles – When working in a team environment, the decision does not always need to go your way. Respectfully agreeing with a leader or the group shows that you can successfully manage change while demonstrating adaptability.

Bring Something To The Table –Be the best you can at what you do, and don’t be afraid to speak up when you have a good idea. Make sure that you are delivering expertise the company will always value. Think constantly about your contribution to the organization and your team.

Keep Your Word – If you commit to a deliverable or a deadline, stick to it. A key element of keeping your word is proactively renegotiating a deadline in advance if you realize you will not be able to reach it. You will gain the respect of all your colleagues due to your reliability. If you come through for others, they will usually come through for you.

Be a Supportive Teammate – Managers should be develop and support their teams. Colleagues should also champion and congratulate one another on accomplishments. You will foster trust and loyalty through your own generosity.

Give Second Chances (Including to Yourself!) – Every employee – including the boss – is going to have a few missteps. When a member of the team is asked to put themselves out on a limb or try something new, they also need to feel there will be a safety net of forgiveness backing them up. Just be candid and admit when one of your teammates, or you, made a mistake, move on, and don’t let it happen too frequently.

source: http://hrservices.sharedhr.com

Leader Standard Work?

Leader standard work? Is it valuable?

Leader standard work as being fundamental to any company that is committed to continuous improvement and culture change. Leader standard work is part of what is included in third principle of manufacturing excellence, i.e., it is the disciplined use of an authorized formal system.

Typically, manufacturing companies are meticulous about creating standard work for machine operators, e.g., job instructions. The job instructions for a particular process are very detailed and represent the required behavior to produce products that meet the customer specification. I hope we always collect the operators’ input before an engineer or technician retires to the office to formalize the instructions.

 But once the job instructions have been committed to the formal system, then we don’t vote anymore about how to do this work. We expect the instructions to always be followed until and unless someone comes up with a better idea to be vetted and tested before changing the standard work and retraining the affected people.

On the other hand, the closest thing many companies have to leader standard work is the position description. Even a very well-thought-out and written position description is far too general to be used on the day-to-day responsibilities.

Leader standard work requires the commitment to detail the important responsibilities of a leader, some of which do not happen from the comfort of the office.

Leader standard work, in the case of the first line supervisor, involves having a daily plan of what the leader’s key duties are. Those might specify, for example, at least three gemba walks and dialog with each person in the area each day.

As we go up the ladder, the plan could become weekly, monthly, quarterly, etc., depending on the level in the organization. For example, a plant manager might commit to a daily gemba walk to touch base with the value stream managers, supervisors and a few hourly associates in each area just to understand how the plant is running each day, what the issues are and, yes, to be visible to everyone.

The plant manager also is behaving in a way that serves to coach people along the way. If the manager sees a potentially unsafe condition, does she walk on by or stop and engage the issue? The leader’s response will speak volumes to all those who are watching to see what happens next.

It’s a teachable moment if handled properly and helps to reinforce the new culture that would expect operators, material handlers, etc., to step up themselves rather than wait on a member of management to respond. Hourly folks typically see these things first, and we want to help them know what to do and feel confident enough to speak up and help keep their teammates safe as well as themselves.

The same kind of coaching opportunity could occur on a quality issue, schedule issue, maintenance, whatever. This important work cannot be done from the office.

The plant manager might also plan and execute a monthly “state of the business” meeting for everyone once a month. The VP of manufacturing/operations might do it quarterly along with a gemba walk. The CEO might do a video for companywide viewing on full-year results and expectations for the new year.

These opportunities to be visible and interactive provide the means to ensure that leadership’s expectations are clear for the results and behaviors that we seek.

source: http://www.industryweek.com

Manufacturing Trends in 2015

Manufacturing Trends that will Shape the Market in 2015

Greater automation and investment driven by accelerated production cycles, advanced technology and changing labor demographics will continue to revolutionize the industry

manufacturing-trends

As 2015 approaches it’s time to look ahead at emerging trends that will impact 21stcentury manufacturing around the globe.

The entire supply chain ecosystem — encompassing manufacturers, distributors and retailers — is undergoing a business transformation. This is in response to changing dynamics involving shifting consumer expectations, time to market and intense global competition that is being dictated by the rising Internet and mobile economies.

Advances in technology — coupled with changing labor demographics — are proving to be the lynchpin shaping this new business model. To remain economically viable, retailers must sell products faster and at competitive prices which sends a ripple effect down the supply chain. For example, manufacturers must accelerate production cycles and distributors must shorten delivery times.

Stakeholders throughout the supply chain have no choice but to adjust their business models to meet consumer demand and increase profits. However, technology is helping businesses stay relevant in these changing times. Let’s take a look at five manufacturing trends that will impact the industry in 2015:

  1. ‘SMAC Stack’ adoption to gain speed.A manufacturing comeback is being driven by SMAC — social, mobile, analytics and cloud. The SMAC Stack is becoming an essential technology tool kit for enterprises and represents the next wave for driving higher customer engagement and growth opportunities. The need to innovate is forcing cultural change within a historically conservative “if it’s not broke don’t fix it” industry, and SMAC is helping early adopters in the manufacturing market increase efficiencies and change.
  2. Social media to further impact business model innovation. According to an IDC white paper, “The Future of Manufacturing,” sponsored by Infor, social media is forcing manufacturers to become more customer-centric. The traditional business-to-business model is becoming outdated because today’s connected consumers are better informed and expect products on-demand. Consumers compare, select or buy multiple products with a tap of their smartphone or tablet, and social media has become their preferred communication platform. This consumer purchasing style is not only having an impact on brand-oriented value chains, but is transforming traditional B2B to B2B2C models.
  3. Internet of Things (IoT) will increase automation and job opportunities.A renewed focus on science and engineering education is cultivating a manufacturing workforce that can manage highly technical systems and allow for greater automation. This frees up employees to put their talents to work on R&D which is helping to redefine what it means to have a career in manufacturing. In addition, IoT allows for condition-based maintenance which is driving efficiencies as businesses save on labor and service costs.
  4. Greater capital investment.Though the slow economic recovery continues to hinder expansion and growth opportunities, recent government and industry reports show an uptick in capital investment funding. As manufacturers become focused on capturing value through innovation, original design and speed to market, they are increasing spend for upgrading plant, equipment and technologies.
  5. The emergence of “Next-Shoring.”The rise of a more technical labor force to manage supply chain operations — combined with rising wages in Asia, higher shipping costs and the need to accelerate time to market to meet retailer and consumer demands — has led to more companies shifting their manufacturing strategies from outsourcing overseas to developing products closer to where they will be sold. “Next-shoring,” as this tactic has been dubbed, allows manufacturers to increase the speed at which product is replenished on store shelves. The faster inventory can be moved to the consumer, the sooner the costs to warehouse, ship and dock goods can be freed up.

These are a few of the game-changing trends expected to impact manufacturing in 2015 and it will be exciting to watch which take off as the industry continues to evolve.

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

Global management standards

The ISO 9001 family – Global management standards (International Organization for Standardization).

 This video from the International Organization for Standardization, explores the worldwide impact on business of the ISO 9000 family of international management standards.

https://www.youtube.com/watch?v=oq1Zi_V4KyE

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