Compliance Resources to Help you Stay Current

Intelli Health Products has announced the inclusion of all lot codes in its voluntary nationwide recall of Duro Extend Capsules for Men.

California Firm, Diana’s Mexican Food Products, Inc. has announced the recall of around 41,670 pounds of chicken tamales. The recall was triggered due to the presence of an undeclared allergen, whey. The company had not declared the same on the label.

The Commodity Futures Trading Commission (CFTC) and the Securities and Exchange Commission (SEC) are preparing a joint study on “the feasibility of requiring the derivatives industry to adopt standardized computer-readable algorithmic descriptions which may be used to describe complex and standardized financial derivatives.”

McCormick & Company, Incorporated (NYSE:MKC), with the knowledge of the Food and Drug Administration (FDA), has issued a voluntary recall of Golden Dipt® Fry Easy All-Purpose Batter, 10 OZ, having the UPC Code 4123470111 and to be used by NOV 17 11 AH as a limited number of packages of the product possessing this date code are said to contain an egg ingredient which does not show on its label.

The fresh&easy™ Ginger Spice Cookie Dough (16 oz.) is being voluntarily recalled by the Fresh & Easy Neighborhood Market. This comes with the alert of undeclared peanuts, which could prove a grave risk to those individuals allergic to it, if consumed by them.

The Food & Drug Administration (FDA) notified Cal-Maine Foods, Inc. about their eggs testing positive in a routine study sample for Salmonella Enteritidis (SE). Ohio Fresh Eggs, LLC is one of Cal-Maine Foods’ suppliers. The routine sample test (environmental study) was done on the eggs from this supplier. Ohio Fresh Eggs supplied around 24,000 dozen eggs (unprocessed) to Cal-Maine, who then processed and repacked them at their facility in Arkansas in October 2010. The notification regarding SE presence went to the company only in the second week of November.

The Securities and Exchange Commission (SEC) launched a new whistleblower program to boost their efforts to uncover fraud. This program offers individuals compensation for valuable tips/leads that are considered critical to the agency. The rule comes under the Dodd-Frank Wall Street Reform and Consumer Protection Act. The procedure is clear-cut, mapping out a transparent process for prospective whistleblowers on how to qualify for the award, provide information and stake their claim for the award.

The Securities and Exchange Commission (SEC) adopted a new rule, making it imperative for brokers and dealers to engage risk controls before allowing customers to trade in the market.

Auditors are trained on how to ask interview questions, but they may not be as well trained on how to let someone know about a nonconforming situation. Let's look at some examples.

1. "You're nonconforming. I'm going to have to write you up."

Well, the person isn't nonconforming. This statement sounds like the person is defective and may need to be scrapped. It is the process that is nonconforming, not the person. And, don't make it personal by saying you will write the person up. You are fact finding, not fault finding.

A better statement might have been:

Records show the process is not being carried out according to the planned arrangements. Since the process requirements aren't being met, this is a nonconformity.

2. "You really screwed up this time. Better update your resume."

Again, don't make it personal, and especially don't make it sound career-ending. An audit should be a penalty-free learning opportunity and a catalyst for improvement.

A better statement might have been:

This activity is being performed differently than the applicable procedure. Unless there is an authorized reason for the difference, this is a nonconformity.

3. "This is a BIG problem. How do you spell your name?"

Nonconformity statements should be written with reference to job titles, not individual names. Keep the focus on the process, not the person.

A better statement might have been:

This product is stored in a different location than called for by the work instruction. Unless this change has been approved, storing the product in the wrong location is a nonconformity.

4. "Why did you do it that way? Were you trained to cause problems?"

Nonconformities are rarely caused on purpose. Don't make things worse with attempts at sarcastic humor. You want the person to understand the problem, not become defensive.

A better statement might have been:

The document is obsolete and not suitably marked to prevent its use as the current version. This is a nonconformity because the document control procedure is not being followed.

5. "What were you thinking? This is a serious violation."

A violation does sound serious, like a legal infraction. Will jail time be involved? Our choice of words can cause a person to react in a negative manner. Don't overstate the situation.

A better statement might have been:

The procedure calls for a final product check before shipment. There are no records indicating this required activity was performed, therefore it is a nonconformity.

While these verbal re-statements may be acceptable, the written versions should be reported with more details. The nonconformity report should state the specific requirement that is not being met, as well as, provide objective evidence that it is a nonconformity.

Upcoming webinars by Larry Whittington at ComplianceOnline:

The Auditee Bill of Rights : January 14, 2011, 1:00 PM to 2:00 PM EST

Get Tough on Corrective Actions : January 27, 2011, 1:00 PM to 2:00 PM EST

Improve Your Audit Checklist : February 8, 2011, 1:00 PM to 2:00 PM EST

About the Author:

Author of this article is Larry Whittington, president of Whittington & Associates, a training, consulting, and auditing company founded in 1993 and located in Woodstock, Georgia. He is an RABQSA certified Lead Auditor and IRCA Principal Auditor, as well as, ASQ certified Quality Auditor and ASQ certified Software Quality Engineer.

Larry has developed requirements, implementation, documentation, and auditing courses used by multiple training firms, and has taught hundreds of classes to thousands of students. His free monthly e-Newsletter on quality and auditing topics has been published for more than ten years and is read by thousands of subscribers. 

Email: [email protected]

As auditors, we are called upon to assess conformity and effectiveness. To assess process effectiveness, we need to evaluate to what extent the planned activities are being realized and the planned results are being achieved.

We may need to venture outside the defined scope of a process audit to fully judge its effectiveness (results). To assess how well the process is meeting the needs of its internal customers, go interview those internal customers. They may have a different view of the deliverables and results than the process supplying them. Their opinion can lead to the facts needed to assess process effectiveness.

Another key element in evaluating effectiveness is to examine the planned results expected by the process owner in terms of their quality objectives. However, some organizations struggle to identify meaningful quality objectives. As an auditor, you may be called upon to explain what is meant by a specific, measurable quality target.

According to ISO 9000:2005, 3.2.5, a quality objective is something sought, or aimed for, related to quality. Clause 5.3 of ISO 9001:2008 says the quality policy is a framework for establishing quality objectives. It also says the policy must include a commitment to 1) comply with requirements and 2) continually improve the effectiveness of the quality management system.

And, it says in ISO 9001:2008, 5.4.1, that quality objectives must be measurable and consistent with the quality policy. Since the quality policy is the framework, it follows that an organization should have an objective to measure the degree to which requirements are being met, plus an objective to measure the results of the quality management system.

If the quality policy identifies other important areas, e.g., product reliability, the organization would be expected to have a measurable target for product reliability. In addition, ISO 9001:2008, 8.2.1, states customer satisfaction is a necessary performance measure for the quality management system.

Even with this guidance, some organizations struggle on how to express meaningful quality objectives. Remember, goals are conditions to be achieved in the future. They should be defined consistent with the organizational vision and mission. Goals are established to guide decisions and actions. However, they usually do not involve measurable results, and therefore, do not change as often as objectives.

Objectives are focused on critical issues and milestones. They describe the activities and targets to achieve your goals. They even identify the dates for completing the activities. They are measurable in terms of being achieved, or not. For example, a general goal might be to reduce waste. The related, specific objective might be to reduce waste from 4% to 3% by the end of the year.

Depending on the industry, organizations might consider quality objectives such as:

Requirements Traceability = Traceable to Design / Total Requirements
Design Stability = Change Requests / Product Releases
Test Rate = Tests Passed / Tests Planned
Scrap Rate = Product Rejects / Products Produced
Problem Rate = Problem Reports / Total Customers
Fix Response Rate = Fixes Closed on Time / Fixes Due
Return Rate = Products Returned / Products Shipped
Repair Failure Rate = Nonconforming Units / Repaired Units
Complaint Rate = Received Complaints /Total Customers
Customer Satisfaction Index = (Questions x Ratings) /Surveys Returned
On-time Delivery = Deliveries by Due Date / Deliveries Scheduled
Service Quality = Defective Transactions / Total Transactions
Milestone Delay = (Phase Duration - Planned Duration) / Planned Duration
Defect Removal = Defects Removed / Defects Reported in Test Cycle
Action Effectiveness = (Actions Taken - Repeated Nonconformities) / Actions Taken

Some of these quality metrics would be expressed over a period of time, e.g., complaints per customer per year. And, some values may be multiplied by 100 to give a percentage. Also, objectives don't have to be variable measures. For example, installation of a new document management system by the end of the year could be a quality objective.

In an article in Management Review nearly thirty years ago, George Doran defined the SMART way to set management objectives. The SMART acronym has evolved since then and can be applied to setting quality objectives. Make them S pecific, M easurable, A chievable, R elevant, and T imed.

Specific : Identify the expected result. Be precise on the desired outcome. All the concerned persons should know what is required.

Measurable : Quantify the result and ensure you have a reliable system for measuring it. You should know when you have achieved the objective.

Achievable : The objective should be realistic given the target and date. Resources must be available to deliver the result with reasonable effort.

Relevant : Links to business success should be clear so people are motivated to meet the objective. Ensure people can influence the outcome.

Timed : Establish a timeframe for reaching the objective. Monitor progress against interim targets on the way to achieving the stated objective.

Quality objectives should be based on comprehensive strategic planning. Organizations must be careful how they set these objectives and how they communicate them. Employees may manipulate processes to achieve the desired results, especially if the numbers are used to judge their personal performance.

When handled poorly, performance targets can result in internal competition and a lack of cooperation. In fact, a specific process objective can be optimized at the expense of overall system performance.

If a target is seen as arbitrary, and set beyond the capability of the process, it may lead to employee frustration, reduced morale, and lower performance. Individuals must feel they have some control over the outcome for an objective to actually promote improvement. The objectives should help monitor and control the processes, not the people.

As auditors, we can use the quality objectives and related results to help us assess process effectiveness. And, we can assist the organization by clarifying the need for specific, measurable quality objectives that help them manage and control their processes and overall business.

Upcoming webinars by Larry Whittington at ComplianceOnline:

The Auditee Bill of Rights : January 14, 2011, 1:00 PM to 2:00 PM EST

Get Tough on Corrective Actions : January 27, 2011, 1:00 PM to 2:00 PM EST

Improve Your Audit Checklist : February 8, 2011, 1:00 PM to 2:00 PM EST

About the Author:

Author of this article is Larry Whittington, president of Whittington & Associates, a training, consulting, and auditing company founded in 1993 and located in Woodstock, Georgia. He is an RABQSA certified Lead Auditor and IRCA Principal Auditor, as well as, ASQ certified Quality Auditor and ASQ certified Software Quality Engineer.

Larry has developed requirements, implementation, documentation, and auditing courses used by multiple training firms, and has taught hundreds of classes to thousands of students. His free monthly e-Newsletter on quality and auditing topics has been published for more than ten years and is read by thousands of subscribers. 

Email: [email protected]

If you've been asked to audit an ISO 9001-based quality management system, how do you develop an efficient and effective audit agenda?

After confirming the audit dates, hours, and location, identify the functional areas that are included in the audit scope. Start by requesting a copy of the quality manual and organization chart. Review the description of the interaction between the processes that is a required part of the quality manual.

List the functional areas from the quality manual and organization chart. You want to know all the processes within the scope and how they interact with one another. Then, list the work hours for the areas so their audits are scheduled during normal hours of operation.

Ask your auditee contact to give you the employee and contractor totals for each of the functional areas. This information will help you determine the audit time to allocate to each area based on size. Other considerations in establishing the audit sample should be recent process changes, risk factors, new technology, process complexity, and new management.

In addition to auditing the applicable requirements for functional areas, you also want to assess the related clauses of the ISO 9001 standard. Therefore, see if the organization has a responsibility matrix that identifies the applicable clauses for each area. If not, talk to your auditee contact and gather the needed information.

You're now ready to create the audit agenda. Using a document template, list times in the first column in 30 minute blocks from the start time to the end time. Block out the events that are independent of the audited areas, such as meetings.

For example, if the work day is 8:00 to 5:00, schedule the Opening Meeting at 8:00, lunch at 12:00, auditor preparation at 12:30, report preparation at 4:00, and the Closing Meeting at 4:30. For a two day audit, Day 1 will end with auditor preparation at 4:00 and a Management Briefing at 4:30. Day 2 will end with report preparation at 3:30 and the Closing meeting at 4:30.

Count the open time slots on the agenda that remain for auditing the areas. Allocate the number of time periods needed for the functional areas to be audited. Some areas may only need one time period (30 minutes), but others may be allocated multiple times periods, e.g., Engineering and Production.

Then, knowing the needed durations, plug the areas into the second column of the agenda in a logical sequence. A typical flow might start with the Quality department for a review of the quality manual and to understand the document control and record control procedures. This overview should help you assess the remaining areas and their linkages.

The next logical area to audit might be top management and their requirements from clause 5 of the standard. Afterwards, you could move to Sales and assess their applicable requirements, including clause 7.2. The audit flow might continue with Engineering (7.3), Purchasing (7.4), Receiving (7.4.3), Planning (7.1), Production (7.5), Test (8.2.4), Warehouse (7.5.3, 7.5.5), and Shipping (7.5.3, 7.5.5). The audit could finish with the Quality department to assess Internal Audit (8.2.2) and Corrective and Preventive Actions ( 8.5.2, 8.5.3).

Verify that all the areas are on the agenda and all the applicable ISO 9001 clauses will be addressed. List the key clauses with each area on the agenda as reminders. Ensure you and any other auditors on the team are independent of the areas to be audited. And, ensure all of you have the necessary competencies for the assignment.

If any of the areas on the agenda are far apart, take these distances into account and show the travel times on the agenda. Also, determine the number of shifts and arrange to sample some from each shift. For example, stay late one day for second shift and arrive early the next morning for third shift. Or, schedule separate audits for each of the shifts.

Send a copy of the draft agenda to the other auditors on the team, to the audit client (the person requesting the audit), and eventually the auditee (the organization to be audited). Ask for their review comments and make the appropriate changes.

Refer to the agenda at the opening meeting and use it during the audit to satisfy the audit objectives. Remember, it is a plan and may need to be adjusted during the audit. Include a copy of the final agenda in the audit report.

Upcoming webinars by Larry Whittington at ComplianceOnline:

The Auditee Bill of Rights : January 14, 2011, 1:00 PM to 2:00 PM EST

Get Tough on Corrective Actions : January 27, 2011, 1:00 PM to 2:00 PM EST

Improve Your Audit Checklist : February 8, 2011, 1:00 PM to 2:00 PM EST

About the Author:

Author of this article is Larry Whittington, president of Whittington & Associates, a training, consulting, and auditing company founded in 1993 and located in Woodstock, Georgia. He is an RABQSA certified Lead Auditor and IRCA Principal Auditor, as well as, ASQ certified Quality Auditor and ASQ certified Software Quality Engineer.

Larry has developed requirements, implementation, documentation, and auditing courses used by multiple training firms, and has taught hundreds of classes to thousands of students. His free monthly e-Newsletter on quality and auditing topics has been published for more than ten years and is read by thousands of subscribers. 

Email: [email protected]

Four companies were warned by the U.S. Food and Drug Administration (FDA) about the “unsafe food additive” in the caffeine used in their malt alcoholic beverages. The warning included the threat of seizing their products, a federal law possibility.

The following companies and products are on red alert:

1. Core High Gravity HG, Core High Gravity HG Orange, and Lemon Lime Core Spiked from Charge Beverages Corp
2. Moonshot from New Century Brewing Co., LLC
3. Four Loko from Phusion Projects, LLC (business activities under Drink Four Brewing Co.)
4. Joose and Max from United Brands Company Inc.

The FDA has classified CareFusion’s decision to recall approximately 17,000 Alaris® PC units (model 8015) which had been manufactured or serviced between December 2008 and September 2009 as Class I recall. CareFusion (denoted as CFN in the NYSE) is a leading global medical device company. The FDA classifies the recall of those items as Class I recall when there is substantial possibility that the use or exposure to the product will call serious health hazards or even death.

The Australia Greens Party has promulgated laws which have enforced restraints on the ability of the nation’s biggest banks to increase the interest rates on mortgages.
 

Del Bueno of Grandview, WA, has issued a recall of all size packages of Queso Fresco Fresh Cheese, Queso Panela Fresh Cheese, Requeson Mexican Style Ricotta Cheese, and Queso Enchilado Dry Cheese as these have been detected to have the potential to be contaminated by Listeria monocytogenes, an organism which can cause serious and at times fatal infections among young children, frail or elderly people, and others with weak immune systems.
 

The Englewood, Colorado-based company said the recall covers those machines which were manufactured and sold before June 2010 and has serial numbers from 001 to 500 and also those from TR1401 to TR 2559.

Infusion pumps are used to deliver fluids -- nutrients and medications such as antibiotics, pain relievers and chemotherapy drugs -- in a controlled manner, and are widely used in hospitals and clinics.

WalkMed detected that the pump door alarms of these devices had the chance of failing to alert the user at the appropriate time, which can potentially cause over-infusion of medication into patients, therefore posing serious health hazards.

The company, however, said that no such accidents have been related till date and the FDA has said in a circular that any untoward incidents may be reported to its MedWatch Adverse Event Reporting program. It must be mentioned here that FDA’s Class I recall which is the highest degree of product recall refers to those products which can pose serious life risk to people.

The Triton Pole Mount Infusion Pump has been distributed to eight customers or distributors all over the country and the company said that five out of them have already been upgraded.

THE LEGAL HURDLE

Title 21 – Food and Drugs of the Code of Federal Regulations (CFR) is the primary regulation for medical devices, which has different sections dealing with various aspects of food, drugs, medical devices, and so on. Among these, 21 CFR 820, the Quality System Regulation, is the most important regulation for medical devises. Violation of this regulation can lead to monetary penalties and seizure of the product being recalled.

RELATED RECALLS

This recall of infusion pumps comes just three weeks after the FDA labeled the recall of CareFusion Corp.'s (NYSE:CFN) Alaris PC infusion units as Class I recall. This recall had covered approximately 17,000 CareFusion infusion units.

In September, Sigma International General Medical Apparatus, LLC similarly recalled its Sigma Spectrum Infusion Pump Model 35700 for reasons similar to the Triton Pole Mount Infusion Pump. In May also, the FDA had ordered Baxter International, a leading manufacturers, to "recall and destroy" all its Colleague brand pumps (approximately 200,000) in the US as the company had failed to ensure quality in spite of repeated notices.

REPORTING DETAILS

Consumers with questions on this product may contact the company directly at 1-303-420-9569 between 8:00 AM and 4:00 PM Mountain Time.

Source:

http://www.scribd.com/doc/37593891/Software-Testing-for-Medical-Devices

The U.S Department of Energy awarded 57 innovative research projects for supercomputing time. The research projects selected use computer simulations that are mostly non-viable or unfeasible in the natural world to perform virtual experiments. The research would use two of the best supercomputers with approximately 135,000 quad-core laptops equivalent computational capacity to provide assistance to multiple areas, for example, improve biofuel production, enhance medication efficacy in slowing Parkinson’s disease progression, and speedup development of more efficient solar cells.

The Department of Homeland Security (DHS) made an announcement proclaiming that all passengers on flights in and out of the country are being verified against government watchlists. This was done one month ahead of schedule in accordance with a 9/11 Commission recommendation. The Transportation and Security Administration (TSA) is now 100 percent responsible for vetting air passengers against terrorist watchlists.

Western Refining Southwest Inc has been fined by the U.S Environmental and Protection Agency (EPA) for failing to monitor benzene discharges and illegally disposing of hazardous waste. This amounts to violation of a Consent Agreement and Final Order (CAFO) filed in August 2009.

A Salmonella scare has led to the recall of Dagoba Organic Chocolate new moon Rich Dark Chocolate 74% cacao 0.32 ounce squares. The Artisan Confectioners Company has announced recall of a limited quantity of its products. Other sizes and other Dagoba items are not covered by the recall. 33 cases of 0.32 oz squares sold across the nation are on recall.