FDA requirement: 21 CFR 820 and ISO 9001:2008

Compliance ISO 9001:2008 to requirement FDA: 21 CFR 820

21 CFR 820: Brief Description: ISO 9001:2008 clauses:
§ 820.1 – Scope.
§ 820.3 – Definitions.
§ 820.5 – Quality system.
General Provisions Scope: 1, 2, 3                                               4.1-General Requirement
§ 820.20 – Management responsibility.
§ 820.22 – Quality audit.
§ 820.25 – Personnel.
Quality System Requirements clause 5: Management Responsibilityclause 8.2.2: Internal Audit

clause 6.2 Human Resources

§ 820.30 – Design controls Design Controls clause  7.3 Design and Development
§ 820.40 – Document controls Document controls clause 4.2 Documentation Requirements
§ 820.50 – Purchasing controls. Purchasing controls. clause 7.4 Purchasing
§ 820.60 Identification.
§ 820.65 – Traceability.
Identification and Traceability clause 7.5.3 Identification and Traceability
§ 820.70 – Production and process controls.
§ 820.72 – Inspection, measuring, and test equipment.
§ 820.75 – Process validation.
Production and Process Controls clause 7.5 Production and service provision                                                  clause 7.6 Control of monitoring and measuring equipment
 § 820.80 – Receiving, in-process, and finished device acceptance.
§ 820.86 – Acceptance status.
Acceptance Activities clause 7.4.3 Verification of purchased product  clause 7.1 Product realization
§ 820.90 – Nonconforming product. Nonconforming product. clause 8.3 Control of noncoforming product
§ 820.100 – Corrective and preventive action. Corrective and preventive action. cluase 8.5.2 Corrective Actionclause 8.5.3 Preventive action
§ 820.120 – Device labeling.
§ 820.130 – Device packaging.
Labeling and Packaging Control

§ 820.140 – Handling.
§ 820.150 Storage.           § 820.160-Distribution

Handling, Storage, Distribution, and Installation 7.5.5 Preservation of product
§ 820.180 – General requirements.
§ 820.186 – Quality system record.
§ 820.198 – Complaint files.
Records clause 4.3 Control of records
§ 820.250 – Statistical techniques. Statistical Techniques clause 8.4 Analysis of data

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

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

Tips for Improvement of Quality in your company

No doubt, we live in an imperfect world: People make mistakes and machines break. The goal is to minimize this so that the client is enchanted and reorders. You can do that through a relentless focus on quality. Improving quality will save your firm money because you won’t need to do things to cover up old mistakes. Improving quality will raise your employees’ engagement because people like being on a high performance team.

How do you make sure quality is exceptional at your firm? Here are  tips to improve quality fast.

Measure and Measure Some More

Two key performance indicators (KPIs) you should deploy today are quality escapes and quality captured. Determine which bucket quality mistakes fall into. The first bucket is comprised of mistakes that were internally “captured” by your team so the client was never aware of them. Captured quality errors aren’t as bad because the client never knew — maybe they suffered a delayed delivery, but that’s it. Your client is not injured by the stumble.

The second bucket consists of quality issues that “escaped” your operation and were discovered by the client. These escaped quality defects are horrific. Your client is exposed to your firm’s failure, which undermines the long term vendor relationship. But measuring these mistakes transparently will bring your team’s attention to these issues and you’ll see improvement from the spotlight effect: The team will understand they are important.

Focus on Process,  Not People

Every employee comes to work to do a good job. In most cases, the defect is the process, not the person you trust. Remember that, and fix it by adding process steps or new checks to the system. Don’t make it a game of “who screwed this up?” That will deflate the team. Everyone will cower in fear and point fingers without ever getting to the root cause.

Meet Weekly

Initially the meetings will be long and tedious. You need to discuss with all the players each quality issue that occurred, and get to the root cause. Over time–less time than you think–the meetings will get shorter, as processes are strengthened and systems get more robust. Confidence will build as people see the systems are catching errors and eliminating heartburn.

Create a Quality Chart

Sort the biggest quality issues by category and focus in on the big issues. Work them till they get to be small issues. Don’t focus as much time on the unusual quality issues; spend your time in the places with the most frequent problems.

Make It Public

Place your quality results in your lunchroom. Everyone should see this is a company emphasis and you want to improve in a transparent way. The daily, visible reminder will demonstrate your commitment to quality to the people who impact it every day: your team.

source: http://www.inc.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

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

Principles of Total Quality Management,

TOTAL QUALITY MANAGEMENT (TQM)
tqm

TQM can be defined as the management of initiatives and procedures that are aimed at achieving the delivery of quality products and services.

A number of key principles can be identified in defining TQM, including:

Executive Management – Top management should act as the main driver for TQM and create an environment that ensures its success.

Training – Employees should receive regular training on the methods and concepts of quality.

Customer Focus – Improvements in quality should improve customer satisfaction.

Decision Making – Quality decisions should be made based on measurements.

Methodology and Tools – Use of appropriate methodology and tools ensures that non-conformances are identified, measured and responded to consistently.

Continuous Improvement – Companies should continuously work towards improving manufacturing and quality procedures.

Company Culture – The culture of the company should aim at developing employees ability to work together to improve quality.

Employee Involvement – Employees should be encouraged to be pro-active in identifying and addressing quality related problems.

Choosing Vendors

hand shakecontact:  kris@themanagementsystems.com

Your vendors have as much interest in your company’s success as you do.

When you make a lot of sales, they make a lot of sales; when you get paid, they get paid. Having reliable and trustworthy vendors can help your business succeed, just as dealing with unreliable or shady firms can cause major setbacks.

Start by asking around; other business owners in your area can be a great source of information. Once you’ve got a list of names, call your local Better Business Bureau to find out whether any complaints have been filed against any of the vendors on your list. You can visit vendor Web sites and even tour their physical locations. You can ask for customer testimonials and for product samples as well. The key is to get as much information as possible before you make a large monetary commitment to a vendor you don’t know.

As you begin to choose vendors, particularly those who will stock your inventory, try to think of them as business partners. You want to choose the ones with whom your company can develop a long-term, mutually profitable relationship, and that relationship starts with your first request for a price quote. Don’t be afraid to ask vendors for quotes; they’re used to it and they probably expect it. After all, this is a major purchase, and it’s never wise to make a major purchase without shopping around — especially when you’re going to a vendor you’ve never dealt with before.

When you’re dealing with a new business and new vendors, make sure to get price quotes from at least two sources for any purchase over $150. If your order will be a lot more than that, consider getting at least three different quotes; more is even better.
If you’re having a hard time finding vendors, and an even harder time finding information about them, you can run your own test by placing a very small order, under $100 in total value. If that process goes well, take it up a notch and place a slightly larger order the next time. Once you feel comfortable with the vendor, you can place your full-blown orders without worry.

Getting Quotes

When you want to make a big purchase for your business, you need to know the total cost upfront. To get that information, you need to ask the people who sell whatever it is you want to buy. In order for that information to be fixed (as opposed to changeable), it’s best to get it in writing. When your company is buying a product, that information will come in the form of a quote; when it’s services you’re after, the quote is usually referred to as an estimate.

The best way to get a quote is to talk with a salesperson; quote requests that come by mail are often ignored. Phone contact is fine, especially after you’ve begun to build a relationship with that vendor or salesman. For your first time out, though, a face-to-face meeting could prove more fruitful, especially if you’re spending a significant sum. Even though salesmen themselves are seldom involved in setting company pricing policy, they often have some leeway when it comes to closing a deal. When you establish a personal connection with a salesman, he’ll work harder with you and for you; after all, making a sale to you is his bread and butter. Flexible areas often include lower unit pricing when you buy in bulk, and better credit terms.

Hitting it off with the salesman is a great start toward developing a good relationship with a vendor. However, don’t stop after getting a single quote just because you like the first salesman you meet with. Another vendor may offer better pricing, better terms, better merchandise, and maybe a salesman that you’ll like even better.

Avoid These Vendors

There are some vendors that you should avoid. If you run across a vendor with one (or more) of the following characteristics, run in another direction:

Accepts cash only

Asks for checks made out to cash

Won’t send a brochure or catalog

Won’t give you a price quote or estimate in writing

Dirty, disorganized stockroom

No warehouse or storage facility

If one (or more) of these factors is the norm in your industry, and the vendor in question has gotten high marks from a reliable source, it’s probably safe to keep him on your list. However, if it’s the vendor telling you this is normal practice, and you can’t verify that with anyone else, look for a different vendor.

http://www.netplaces.com/accounting/controlling-purchase-costs/choose-your-vendors-wisely.htm

%d bloggers like this: