Tag Archives: ISO 9001:2015 consulting

ISO 9001- 2008 consulting

Mar 8 2015

Customer Focus – Quality Principle

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and
strive to exceed customer expectations.
• Increased revenue and market share obtained through flexible and fast  responses to market          opportunities

• Increased effectiveness in the use of the organization’s resources to enhance
customer satisfaction
• Improved customer loyalty leading to repeat business.
• Researching and understanding customer needs and expectations
• Ensuring that the objectives of the organization are linked to customer needs and expectations
• Communicating customer needs and expectationscustomer
throughout the organization
• Measuring customer satisfaction and acting
on the results
• Systematically managing customer relationships
• Ensuring a balanced approach between satisfying customers and other interested parties (such as owners, employees, suppliers, financiers, local
communities and society as a whole).

http://www.iso.org

Reklama
Sty 31 2015

The Role of Quality

The Role of Quality

 As organizations evolve quality from merely being a ‘checking the compliance boxes’ to really using quality practices to impact and empower staff to make improvements and address customer needs, there is opportunity for a greater return on investment and improved customer satisfaction. Organizations that use quality as a source of competitive advantage, operational excellence, or as a continuous improvement activity are much more likely to embrace the customer-centric, quality culture.

For example organizations that use quality as a source of competitive advantage are more likely to make their quality measures transparent to their customers (76.4%) than those who use it as a compliance activity (46.6%). This is particularly true for understanding what defines culture from the customer’s perspective.

Integration in Strategic Planning

To understand what’s truly valuable to the organization, one has to look at what makes it into the strategic plan. Although there is always intrinsic value in the use of quality goals and measures within an organization, it is when these goals are established across the organization—corporate, management and support services, and operational businesses and functional units—that quality can have the greatest impact on overall performance.

Level of Transparency

Transparency on quality measures helps create buy-in on quality management and enables employees to understand what role quality plays in how they do work, how they can impact quality, and its effects on their customers’ satisfaction. Transparency breeds accountability at the most basic level and even drives a healthy competition between business units. It also tends to increase knowledge-sharing opportunities (e.g., best practices or lessons learned), as managers with lower performance often reach out to managers in groups with higher performance, even across diverse products and services within the same organization.

Use of Quality Measures

The majority of respondents use quality measures to set goals that will drive higher performance throughout the organization (76%), for predictive analysis to identify potential opportunities or issues in their operations and business process (66%), and as part of their variable-performance compensations (61%). However organizations that include quality measures to drive higher performance or for operational improvement are more likely to agree with the customer-centric, quality cultural statements. This adoption indicates that the organization has embraced the quality culture and it’s simply now how they do business.

source: http://www.industryweek.com

Gru 12 2014

ISO 9001:2008 to ISO/DIS 9001 Correlation Matrix

What to expect in new revision of ISO 9001? ISO 9001

ISO 9001:2008 to ISO/DIS 9001 (rev.2015) Correlation Matrix

ISO 9001:2008 ISO/DIS 9001
4        Quality management system 4         Quality management system
4.1     General requirements 4.4     Quality management system and its processes
4.2     Documentation requirements 7.5     Documented information
4.2.1  General 7.5.1  General
4.2.2  Quality manual 4.3     Determining the scope of the quality management system

7.5.1  General

4.4     Quality management system and its Processes
4.2.3  Control of documents 7.5.2  Creating and updating

7.5.3  Control of documented Information
4.2.4  Control of records 7.5.2  Creating and updating

7.5.3  Control of documented Information
5         Management responsibility 5        Leadership
5.1      Management commitment 5.1     Leadership and commitment

5.1.1  Leadership and commitment for the    quality management system
5.2      Customer focus 5.1.2  Customer focus
5.3      Quality policy 5.2     Quality policy
5.4      Planning 6        Planning for the quality management system
5.4.1  Quality objectives 6.2     Quality objectives and planning to achieve them
5.4.2  Quality management system planning 6        Planning for the quality management system

6.1     Actions to address risks and opportunities

6.3     Planning of changes
5.5      Responsibility, authority and communication 5        Leadership
5.5.1   Responsibility and authority 5.3     Organizational roles, responsibilities and  authorities
5.5.2   Management representative           Title removed

5.3     Organizational roles, responsibilities and  authorities
5.5.3   Internal communication 7.4     Communication
5.6      Management review 9.3     Management review
5.6.1   General 9.3.1  Management review
5.6.2   Review input 9.3.1  Management review
5.6.3   Review output 9.3.2  Management review
6         Resource management 7.1     Resources
6.1      Provision of resources 7.1.1  General

7.1.2  People
6.2      Human resources           Title removed

7.2     Competence
6.2.1   General 7.2     Competence
6.2.2  Competence, training and awareness 7.2      Competence

7.3      Awareness
6.3      Infrastructure 7.1.3  Infrastructure
6.4      Work environment 7.1.4  Environment for the operation of processes
7         Product realization 8         Operation
7.1      Planning of product realization 8.1      Operational planning and control
7.2      Customer-related processes 8.2      Determination of requirements for products and services
7.2.1  Determination of requirements related to the product 8.2.2  Determination of requirements related to products and services
7.2.2  Review of requirements related to the product 8.2.3  Review of requirements related to the products and services
7.2.3  Customer communication 8.2.1  Customer communication
7.3      Design and development 8.5      Production and service provision
7.3.1  Design and development planning 8.3      Design and development of products and services

8.3.1  General

8.3.2  Design and development planning
7.3.2  Design and development inputs 8.3.3  Design and development Inputs
7.3.3  Design and development outputs 8.3.5  Design and development outputs
7.3.4  Design and development review 8.3.4  Design and development controls
7.3.5  Design and development verification 8.3.4  Design and development controls
7.3.6  Design and development validation 8.3.4  Design and development controls
7.3.7  Control of design and development changes 8.3.6  Design and development changes
7.4      Purchasing 8.4      Control of externally provided products and services
7.4.1  Purchasing process 8.4.1  General

8.4.2  Type and extent of control of external provision
7.4.2  Purchasing information 8.4.3  Information for external providers
7.4.3  Verification of purchased product 8.6      Release of products and services
7.5      Production and service provision 8.5      Production and service provision
7.5.1  Control of production and service provision 8.5.1  Control of production and service provision

8.5.5  Post-delivery activities
7.5.2  Validation of processes for production and service provision 8.5.1  Control of production and service provision
7.5.3  Identification and traceability 8.5.2  Identification and traceability
7.5.4  Customer property 8.5.3  Property belonging to customers or external providers
7.5.5  Preservation of product 8.5.4  Preservation
7.6      Control of monitoring and measuring equipment 7.1.5  Monitoring and measuring resources
8.0      Measurement, analysis and improvement 9.1      Monitoring, measurement, analysis and evaluation
8.1      General 9.1.1  General
8.2      Monitoring and measurement 9.1      Monitoring, measurement, analysis and evaluation
8.2.1  Customer satisfaction 9.1.2  Customer satisfaction
8.2.2  Internal audit 9.2      Internal audit
8.2.3  Monitoring and measurement of processes 9.1.1  General
8.2.4  Monitoring and measurement of product 8.6      Release of products and services
8.3      Control of nonconforming product 8.7      Control of nonconforming process outputs, products and services
8.4      Analysis of data 9.1.3  Analysis and evaluation
8.5      Improvement 10       Improvement
8.5.1  Continual improvement 10.1   General

10.3   Continual Improvement
8.5.2  Corrective action 10.2   Nonconformity and corrective action
8.5.3  Preventive action            Clause removed

6.1       Actions to address risks and opportunities (see 6.1.1, 6.1.2)


Gru 11 2014

ISO 9001 Revision 2015 Is Coming

The ISO 9001 Revision 2015 timetable for development is as follows:

July 2015 – Final Draft International Standard ballot opens
August 2015 –  Final Draft International Standard ballot closes
9 September 2015 – ISO 9001:2015 International Standard is published
 According to the draft design specification, the revised ISO 9001:2015 standard should:
  • Provide a stable core set of requirements for the next 10 years or moreISO
  • Remain generic, and relevant to all sizes and types of organization operating in any sector
  • Maintain the current focus on effective process management to produce desired outcomes
  • Take account of changes in quality management systems practices and technology since the last major revision in 2000
  • Reflect changes in the increasingly complex, demanding and dynamic environments in which organizations operate
  • Enhance compatibility and alignment with other ISO management system standards
  • Facilitate effective organizational implementation and effective conformity assessment by first, second and third parties
  • Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements

Seven Significant Changes in ISO 9001 Revision 2015 Committee Draft

  1. The term „product” has been replaced by „goods and services”.
  2. Two new clauses related to the context of the organization:
    4.1 Understanding the organization and its context
    4.2 Understanding the needs and expectations of interested parties.
  3. The requirement to use the „process approach” has been more explicit by adding a new clause.
    4.4.2 Process approach
  4. The standard does not include a specific clause for „Preventive Actions”.
  5. The terms „document” and „records” have been replaced with the term „documented information”.
  6. of external provision of goods and services address all forms of external provisions.
  7. The term „continual improvement” has been replaced with „improvement”.

 

List 25 2014

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

List 18 2014

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

List 17 2014

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

List 17 2014

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
List 17 2014

Internal Auditing – How Often ?

audit image4

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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