Tag: supplier

Top 5 Best Practice Tips: Implementing or Transitioning to ISO 9001:2015

–Guest blog post by Robert Jasper–

The well known magazine manufacturingnews.com and the Dallas Business Journal indicate that 85% of ISO registered firms report external benefits like higher perceived quality, greater customer demand, better market differentiation, greater employee awareness, increased operational efficiency, and reduced scrap expense. Results like 30% reduction in customer claims, 95% improvement in delivery time, reduced defects from 3% to 0.5%, 40% reduction in product cycle time, 20% increase in on-time delivery are achievable after correct implementation of an ISO 9001 based quality management system.

For those considering implementing ISO 9001:2015, or for those in the 2008 transition process, here are five best practice tips:

Tip 1: Conduct a Gap Analysis Audit

It is important to consider everything can be implemented quickly, with not many resources involved and of course ending in an successful ISO 9001 certification within reasonable cost and time frames. The best tip is to plan out your implementation/transition project right from the start in effective and efficient ways by conducting a 100% compliance Internal Gap Analysis Baseline Audit against all the existing requirements of the international quality management standard in relation to your existing quality management system. And, it does not matter whether you are an ISO 9001:2008 certified company or organization, as this approach will always provide you with the exact planning requirements for your implementation or transition project. A clear implementation structure based on how to close gaps in your existing quality management system with clear responsibilities and due dates for gap closure and ISO certification readiness always helps to keep projects of this importance on track and on time.  These findings and “gaps” will also give you project opportunities to reduce costs and improve your bottom line profitability. This way, you start to make your QMS work for you right from the start!

Tip 2: Create Process Compliance

Documenting all of your core processes is a way of describing current state and anticipated ISO 9001:2015 compliant future state will create compliance to existing ISO 9001:2015 requirements for having implemented a sound process approach. It may also create the first “A Plus” in the eyes of your Third Party Registrar later on during your ISO Certification Audit, as Registrars are required to audit organizations on detailed documentation of how the organization has created process compliance to the new ISO 9001:2015 standard requirements. This is a direct requirement the Registrars have by the International Accreditation Forum (IAF).

Tip 3: Document Development Data Mining and Definition of QMS Objectives

Also not directly required anymore by the new ISO 9001:2015, it makes sense to structure out a Quality Manual reflecting your Quality Policy, as well as listing all your Standard Operating Procedures to run your QMS. Well developed goals and objectives for your QMS are quantitative numbers that you set in order to measure your QMS performance along the way. Many firms collect data, but it’s what you do with it that gives you your best“Bang for the Buck” for your QMS! Don’t just collect data for the sake of collecting data….make it mean something to your firm!

During this stage of development, you should look thoroughly at the Risk Plans for your firm; in case of global supply chain a “holistic” global oriented Continuity Risk Plan but also think about a local Contingency Plan will cover the new “Risk Based Thinking” requirements of ISO 9001:2015 best. Failure Mode Effect Analysis (FMEA) alone cannot cover all operational risks, therefore any kind of sufficient developed Risk Plan/Register which covers also operational and management risk, might do the job much better – to keep you safe during Third Party Audits.  Changing the mindset from product risk to overall risk management is required here, which may save you cost in the long run anyway – right?

Tip 3: Training and Implementation Roll-Out

The KEY mistake that most firms make is the training and reporting of the ISO process only to all employees. Only with buy-in from the TOP of the org-chart, all the way down to all part-time and contract employees, ensuring complete understanding and participation is needed to make your system work for your firm. During this phase, you want to educate your entire staff on the ISO program and how their job functions affect the QMS. Defining objectives and goals for departmental managers to implement projects and action taking for improvements and corrective actions is a good thing to have in place as well. This is where you see the payback!

Tip 4: Readiness “Mock Audit” and QMS Management Review

Okay, you’ve worked hard and come a long way towards getting obtaining your ISO certification. At this phase, you should complete a full round of internal audits on your QMS and assign documented corrective actions on any findings that may have been transparent in the earlier reviews. These are good because they act as a guide for your measurable metrics defined in your QMS. Anything you find internally is a bonus for your QMS continual improvement process! Once the cycle is complete, it’s time to conduct your QMS Management Review. This is where Top Management will review the progress, goals, objectives and inter-company metrics of your entire quality management. Total Management support of the QMS is vital for the success of making your QMS system work for your organization, and not YOU work for the quality system.

Tip 5: Final Preparations 

You’ve come a long way, and you worked hard. Now it’s time to show what you have done as a team and obtain that recommendation for ISO Certification given by the Third Party Certification Registrar! Wrap up any outstanding customer complaints, non-conformities or audit findings. Celebrate your business success. You’re on the path towards making your company a benchmark for other companies to set their standards higher… GOOD JOB!

Robert Jasper is the author of the upcoming book “HIGH PERFORMANCE QMS™”, which elaborates how organizations of all sizes can use the new ISO 9001:2015 standard principles and requirements to create organizational performance improvement (Release summer 2016). Robert is a certified International Auditor and ISO Consultant/Trainer for ISO 9001 Quality Management Systems. He is specialized in result-based Quality Management Consulting and holds regular seminars/workshops on ISO 9001 matters. Robert has trained and consulted organizations of all sizes and various industries to develop, implement, and certify their QMS systems successfully by Third Party registrars. His QMS training style is effective, collaborative and focused on simplification of all ISO matters. Robert is a certified ISO 9001:2015 transition trainer, based on training provided by EXEMPLAR GLOBAL (formerly known as RABQSA), an international recognized authority body in all ISO matters providing professional credentialing programs and training certification programs.

 

For more information regarding our ISO consulting and auditing, or to discuss your 2015 transition process, please contact us. 

Supplier Selection & Management: What You Need To Know

Our latest quarterly newsletter Feature Article discussed strategic supplier selection. Due to the response we’ve had, we wanted to follow-up on our blog.

We were surprised to discover many of our newsletter subscribers didn’t know a variety of options existed for gaining additional assurances when going through the supplier selection process.

Determining which option you leverage involves the level of risk you’re willing to take in the process.

What are the options?

Legal Verification

The most basic information that you will want to have verified by an external source includes legal verification. Is the supplier legally able to partner and produce products for you? It becomes less clear how to do that when you’re looking at potential suppliers abroad. Using a 3rd party with local access is often preferred due to the cost and time required to execute internally.

Credit Standing

Another indicator of performance is generally an organization’s credit rating.

Supplier Verification

Does the supplier exist, and are they observably consistent with the information they provided. For example:

  • How many employees work there?
  • How many years have they been in business?
  • Who are their top three customers and what percent of sales do they make up?
  • Do they have any certifications?
  • What does the factory look like?
  • What equipment is available on-site?
  • How many production lines are there?
  • Do they subcontract anything to other suppliers?
  • What is their product capacity?

Supplier Audit 

This on-site evaluation is performed by a quality professional that specializes in evaluating quality management systems.  The idea is to gain assurances on a number of applicable topics through objective evidence.  In general, the auditor looks at the following and provides a comparative analysis of conformances and non-conformances:

  • Management
  • Engineering
  • QC & Assurance
  • Incoming Receiving Inspection
  • Manufacturing
  • Packaging
  • Non-Conforming Materials
  • Corrective Action
  • Inspection & Test Equipment

Specialized Audits

Depending on your industry or other factors, specialized audits may be required. For example, many stakeholders now demand organizations support their social responsibility claims with on-site audits. SA8000 or social-based audits specialize in topics related specifically to the workforce and human rights issues.  Other examples include:

  • Automotive ISO/TS 16949
  • Medical Devices ISO 13485
  • Environmental ISO 14001
  • GMP

Combination Audits

It’s often possible to create a combination audit to address certain components of multiple areas. For example, due to cost considerations, a company may prefer to combine the social accountability components with a more general QMS review.

Contact us for more information! Share with us how you select suppliers…

A New Year for Quality

As 2016 gets started, there’s reason to believe it will be a good year for quality.

We reached out and asked our clients and partners what their quality goals are for the year. We received some positive and reassuring feedback.

Common quality objectives and a few helpful resources include:

  • Establish (or improve) a supplier evaluation program. 
  • Utilize existing inspection data to identify trends and make improvements.
    • Check out a previous blog post where we use inspection data and a fishbone diagram to determine root cause.
    • Follow-up when opportunities for improvement exist.  For example, consider a process audit when consistent defect trends are noted.
  • Evaluate new suppliers.

For some New Year quality inspiration, check out our Quality Quotes page.  Add any of your favorites to the comments!

“The new year stands before us like a chapter in a book waiting to be written. We can help write that story by setting goals.” ~Melody Beattie

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ISO 14001:2015 – Who Needs Environmental Management?

aa6efe67-5c6a-4d07-862e-1cb1ab7145a4-largeThe quality industry is buzzing this week as the International Organization for Standardization released the latest revision of the ISO 14001 environmental management standard.

“ISO 14001:2015 is an internationally agreed standard that sets out the requirements for an environmental management system. It helps organizations improve their environmental performance through more efficient use of resources and reduction of waste, gaining a competitive advantage and the trust of stakeholders”

Notable revisions per the news release include:

  • A greater commitment from leadership
  • An increased alignment with strategic direction
  • Greater protection for the environment, with a focus on proactive initiatives
  • More effective communication, driven through a communications strategy
  • Life-cycle thinking, considering each stage of a product or service, from development to end-of-life

With the latest release, ISO discussed the benefits of incorporating the standard.  Described as a way of helping organizations identify, manage, monitor and control their environmental issues in a holistic manner, issues considered include:

  • Air pollution
  • Water & sewage issues
  • Waste management
  • Soil contamination
  • Climate change mitigation & adaption
  • Resource use & efficiency

So, who needs environmental management? The upside of 14001 is that it’s easily integrated into the existing ISO QMS, so any organization can benefit.  While Pro QC does not certify to ISO standards, we add value by getting our clients ready.  Our 14001 based audit gives clients assurance for certification, or a general assurance to stakeholders.  Many organizations not seeking certification continue to incorporate this standard simply to enjoy the associated benefits.

What are the benefits? According to ISO case studies, users of the standard indicate that it helps:

  • Demonstrate compliance with current and future statutory and regulatory requirements
  • Increase leadership involvement and engagement of employees
  • Improve company reputation and the confidence of stakeholders through strategic communication
  • Achieve strategic business aims by incorporating environmental issues into business management
  • Provide a competitive and financial advantage through improved efficiencies and reduced costs
  • Encourage better environmental performance of suppliers by integrating them into the organization’s business systems

Pro QC’s ISO 14001 based audit goes through a detailed checklist developed with the use of the standard (4:Quality Management System). We incorporate the following to provide clients with assurance in their suppliers’ environmental management.

  • Factory (supplier) profile
    • Markets, key clients/personnel, QMS, equipment, etc.
  • Environmental policy
  • Planning – environmental aspects
  • Legal and other requirements
  • Objectives, targets and programs
  • Resources, roles, responsibility and authority
  • Competence, training and awareness
  • Communication
  • Documentation
  • Control of documents
  • Operational control
  • Emergency preparedness and response
  • Monitoring and measuring
  • Evaluation of compliance
  • Nonconformity, corrective action and preventive action
  • Control of records
  • Internal audit
  • Management review

An audit result indicates scores represented as a percentage of the following:

  • Complies with the requirements
  • Improvement needed
  • Non-conformances found

Our reports provide the detailed information clients need to make imperative sourcing decisions. Whether it’s an evaluation to determine supplier selection, part of a supplier management initiative, or for internal evaluation purposes, the benefits of incorporating an EMS are relevant to organizations across all industries.

Contact us to schedule an ISO 14001: 2015 audit, or ask us questions. Download an example report here.

When do you switch suppliers?

supplier-quality-devoI’ve never heard the process of switching suppliers described as easy.  People may say that it “went smoothly” or “could have gone worse,” but the reality is that it’s not easy.  Because of this, many organizations delay the process and experience increased costs and consumer dissatisfaction as a result.

Questions to consider:

  1. Do you know how your suppliers are performing?
  2. Do you know how your suppliers should be performing?
  3. Are your suppliers adapting to growth?

Not all issues with suppliers are immediately obvious. If you’ve answered no to any of these questions, it’s likely you’re unable to determine if you should switch suppliers because you don’t have the data you need.

In general, organizations decide to switch suppliers for these reasons:

  • The supplier is no longer reliable and communication efforts have failed. Symptoms include consistently late shipments, damaged goods, etc.
  • The supplier is disengaged.  They show a lack of interest and often fail to follow-up
  • The supplier is not able to stay current in the market and is no longer competitive in price.
  • The supplier is adding “extra-sale costs” such as rework to product, backorders, extra training, etc.

When deciding to pursue new or additional suppliers, consider the following:

  • Know who your ideal supplier is. Profile the perfect partner.
  • Develop a questionnaire to use when scouting.
  • Use a 3rd party to conduct a supplier assessment (audit) on the top prospects.
  • Use a non-biased quality tool such as a grid analysis to compare findings and make a decision.
  • Learn from prior supplier relationships and carefully construct any new partnerships as to avoid future issues.

The right suppliers make a difference.  It’s worth it to evaluate performance regularly and take appropriate actions to ensure strategic partnerships. Benefits include:

  • Prevents issues with quality, communication, the buying process, etc.
  • Higher likelihood that products consistently meet delivery expectations.
  • Reduced costs over short and long-term.
  • Increased operational efficiency. Drives supply chain excellence.
  • An overall improvement in service and customer perception.