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 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

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

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

Total Quality Management Strategies: Advantages & Disadvantages

Total Quality Management Strategies: Advantages & Disadvantages

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

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

Lowers Production Costs

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

Employee Resistance

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

Employee Participation

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

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

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

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

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