Essential Elements of a Quality Management System

A good quality management system in a pharmaceutical company can significantly improve the net profit status, high quality medicines for patients, less rework and recall which save more money, good work environment and compliance with local and international regulations.

Quality management is a philosophy. It takes management understanding, commitment and responsibility before introducing and implementing the concept. Once practiced a good quality management system slowly develop or reshape a sustainable organization culture that pays off rapidly.

The initial step of introducing a good quality management into a system is to know the essential elements of the quality system and clear study from where to start. Company objectives should be clearly understood. Policies should be prepared. Then comes the design of the process flow, validating the process, material flow and organization chart. When a good integration between people, process and material is achieved the next step is to putting the integrated system in a state of control. Any deviation from the controlled system must be analysed and corrected.

Some basic but essential elements of Quality Assurance as depicted in GMP guidelines and ISO 9001 guideline for pharmaceutical industry can be listed as: the Preparation of standard operating procedures of a complete system maintaining cGMP principles; Preparation and maintenance of effective change control of quality and master file documentation; Recording and management of manufacturing change control; Recording and reporting procedure of Deviations of your systems; Quality concern investigation process; Customer complaint investigation procedure; Quality audit procedures; Vendor assessment, evaluation and certification procedure; Quality control laboratory procedure, Rework procedures for the defective manufactured products; Procedures on training for manufacturing staffs and recall procedure.

Standard operating procedures and manuals should be written in details and referenced to relevant other documents, so a new starter within the organization should be trained easily and expected to perform as per procedure. The result will be a common standard of activities across the organization, good tractability of work flow, deviations and ease of corrective actions as necessary.

Standard Operating Procedure

You should prepare SOPs, forms, templates and manuals, which can be used immediately as the system runs. Forms and templates should be used for record keeping which your people can follow routinely.

Documentations – Classification, Definition and Approval

Quality and Technical/Master file documents to be created to build up a good quality management system for your manufacturing sites. Definition of documents, their classification, approval requirements and retention requirements should be understood.

Quality Documentation Management and Change Control

Procedures to be created on how to generate new quality documents or change control of existing documents, review of quality documents, satellite file management, role of document author, approver, document control officer and satellite file administrator. In this procedures you will also define the numbering systems of different quality documents like audit files, SOPs, forms, templates, manuals, training files, QA agreements, project files etc and their effective archiving system.

Preparation, Maintenance and Change Control of Master Documents

Procedures to be created which will particularly focus on the management of master file documents like specifications, control methods, raw materials, finished goods and packaging specification and test reports, formulation, stability files etc required to generate during the product registration in the market.

Deviation Report System

It is a regulatory requirement to capture all sorts of deviations evolves in your systems in order to maintain the continuous improvement of your processes and systems. Procedures should be created that describes how to categorize the deviations between production, audit, quality improvements, technical deviations, customer complaints and environmental, health and safety deviations. It should also describes the management responsibilities of initiating deviation, capturing data, analysis, investigation, determination of assignable cause/s, generation of management report and initiatives to be taken on corrective and preventative actions.

Vendor Selection and Evaluation

Procedures to be followed during the vendor assessment and vendor evaluation for purchasing of raw materials, critical and non critical packaging components, laboratory supplies, engineering supplies and imported finished goods from the vendor. These instructions are essential for approving prospective vendor.

Vendor Certification

This procedure aims to describe the process by which a vendor may be certified to supply materials or services. This procedure applies to vendors that supply a material or service to be used at any stage of manufacture by operations. Here you will describe the roles of each department in the process to certify an approved vendor.

Product Complaint Procedure

You should have strong procedure to cover the receipt, logging, evaluation, investigation and reporting system of all complaints received from customers for the marketed products. This procedure should contain step by step instruction to be followed during the customer complaint management like numbering of complaint, registering the complaint, evaluation, determination of assignable cause for the complaint deviation, implementation of corrective and preventative actions, trending of complaints and handling of counterfeit products.

Annual Product Review

Some countries require reports as Annual Product Review to sell your products into their market. So you have to create instructions on how to do annual product review, to evaluate data, trends and to identify any preventative or corrective action that would lead to product quality improvements and report them to management.

Rework Procedure

Procedure should contain the step by step instructions to be followed when the rework of an in-process or completed finished good is required. Product Identification and Traceability The purpose of this procedure is to define the method used for the identification of all contributing materials that could affect product quality and to ensure their full traceability.

GMP Audits

Procedure should be created to describe the process of planning, performing, reporting and follow-up of different audits for your systems like Internal Quality audit, Vendor audit, Environmental Health and Safety (EHS) audit, EHS workplace inspection, Housekeeping audit.

Evaluation of Batch Documentation and Release for Sale

This procedure should describe the process of collection, evaluation and record of batch related document generated during the production of a batch before an authorized person can release the batch for sale.

GMP Training

Effective GMP related training modules to be created for your manufacturing staffs. Training records and reports have to produce on each employee as justified.

Management and Control of Contract Work

There should have procedure to describe the management and control of contract work provided by the contractors for packaging and finished products for your company as well as control of contract works done by your company on behalf of others.

Quality Concern Investigation Process

Procedure should be made that contains instructions to follow when conducting Investigations collection of data and information, analysis, assigning root cause, determine corrective and preventive actions.

The 4 Elements That Makes Up A Personal Computer System

There are 4 elements that make up a personal computer system: the user, software, hardware and the electricity all working together for the whole system. Each of these elements is essential to the system itself.

The user is the person’s who perform the task using the computer system. The nature of the task depends upon the application program or software that is needed to perform the task. The software that the user used requires certain hardware components to function properly.

The hardwares of the personal computer system are made up of its equipment that are usually connected (the computer, monitor, printer and so on). It is defined as hardwares because you can physically touch these components. The programs are called softwares since their function can only be used when the computer is turn ON. Software is a set of coded instructions that the computer uses in order to carry out the user’s tasks.

The user can only use the computer when it is turned ON. Without any electrical power to run through the personal computer system, it will not function. The ability of the personal computer system to control its components is through a series of on/off signals.

Here is how it works, when a user tries to type a document or a letter using his/her personal computer. The first thing the user do is to turn ON the power for the computer. Choosing a Word Processor software in order to write the document. The user uses the hardware such as the keyboard to write the content of the document; the typed document is then displayed onto the monitor screen. After the user finished writing his/her document. The user will use the software to instruct the printer to print the document. The software works together with the hardware components (the keyboard, monitor and printer) to accomplish the task that the user requested.

All of the four elements: the electrical power, hardware, software and the user work together to make up a personal computer system.

How to Handicap a Harness Race – A Simple System to Pick Winners at the Trots

Whether betting on trotters or pacers, if you want to make the most of your bets at the harness races, it is best to stick with a system, even if it is a simple one. Obviously, the more you learn about harness racing and handicapping, the better you'll do, but if you want something easy to get you started, here are a few good tips about harness that that you can use in a systematic method to pick harness winners .

First of all, in harness racing, the length of the track is very important because it determines how far each horse has to race and may give a big advantage to some horses. While most dashes, as they are called in North America, are a mile long, the tracks vary in length from a half mile to a mile. Half millers often give a big advantage to horses starting from the inside positions. It is very rare for a horse starting from a post position farther from the rail than the 5 post to have much of a chance on a half mile track.

The horses in outside posts do sometimes win, but that can be for one of several reasons, if they are far superior they have a chance, or if there is trouble in the race, like an accident or horses breaking stride, an outside horse sometimes wins. Otherwise, when handicapping half mile tracks, pay particular attention to post position and biases. Good past performances now supply an index which supplies that information in the form of a percentage. No matter how long the track, it is always a good idea to check the post position statistics. If you have little knowledge of picking winners, sticking with favorable posts is a good place to start.

The next step is the driver and trainer. While some harness drivers joke that they are just a passenger, if you read the statistics on the drivers, you'll find that some win up to three times as often as others. The same may be said of trainers. That information is usually posted right beside the driver and trainer names. A horse in an inside position with a good driver is starting to look like a good bet, is not it?

Harness horses, like all athletes, need to be in top condition to compete. What is the best way to find a harness horse in good form? Look for a horse who finished within two lengths of the winner in its last race or who posted the fastest time of any horse in the current race in one of its last two races. When you put the combination of a good post position together with a competent driver and trainer and a horse who is showing good form, you will have plenty of winners using this simple harness racing system.

Service Industry Lean Manufacturing – Implementation Guide

Non-manufacturing industries have not embraced lean manufacturing to the same extent as those producing a product. Some service industries have found the same principles apply, although the use of lean manufacturing tools is different.

For example, a value added analysis is just as easily conducted with a worker talking on the telephone as someone using one.

The 5S tool can be used to organize the surroundings in the telemarketing office. All materials the telemarketer uses should be organized and within reach without having leave the area. This 5S organization enables the telemarketer to continuously utilize any material in front of them as well as keep an eye on a computer.

The same SMED tools can be used with a administrative assistant as a machine operator. The process map and movement will show the waste in each. The assistant’s travel shows the motion waste. The waiting waste is often huge in any white collar or service job. For example, the waste from waiting on a colleague, manager, supplier, or anyone else can be eliminated. There are ways to minimize it by removing the root cause as well as finding activities to fill the time. These activities should be of short duration, such as data entry, filing, or printing.

Line balancing is easy in a service environment. The key is flexibility. For example, two tellers at a bank may be required 6 out of 8 hours per day, but the trained lean expert or industrial engineer is required to notice it. The additional two hours of waste comes in buckets of 1-2 minutes throughout the day. Again, this time must be filled with value added activities in a standard work format. If the job isn’t standardized, the two individuals may absorb the time and appear 100% busy. There are many other instances where job combinations are obvious.

The value stream map is an excellent tool for service industries. Rather than the traditional macro level view of the system, the value stream map can be used in a department or area of the business. An example would be the service desk at a department store. Begin with the information flow and trigger for activity, which might be a customer. Break the map into various segments showing the few activities that comprise 90% of the work, such as returned goods, request for information, or complaints. Standardized Operations should be utilized for returned goods to minimize motion and waiting, such as a decision flow diagram. If the manager is called a large percentage of the time, the decision flow diagram needs improved. Obviously the 5S and SMED tools are also relevant, as well as root cause problem solving to eliminate the complaints.

Service industries often use kanbans without knowing it, such as ordering supplies. The same pull systems can be used in service industries as the manufacturing sector. The supply distribution center is one obvious example. Inventory waste can be eliminated using pull systems beginning with the end downstream customer.

When implementing lean manufacturing in a service industry, it is important to tailor the training to the business. Most SMED (single minute exchange of die) training is developed using examples of setup activities for equipment. It is easier for people to understand and see the waste in their processes when the training has obvious applicability.

One of the best long term lean manufacturing tools to apply in a service industry is the kaizen event. Kaizen means “incremental improvement” in Japanese. The kaizen team is comprised of a cross functional team developed to quickly and substantially improve a business issue. For example, a kaizen might be developed to reduce hospital check in time for testing. The team might include the individuals conducting the check-in, a nurse, manager, an IT representative, and a couple customers. If the average check in time is 35 minutes (the elapsed time from walking into the building until seated in a private room), the kaizen objective might be to reduce the check in time to 20 minutes within 5 days.

Cellular manufacturing can be used in many service businesses. Rather than placing individual pieces of equipment such as the postage meter, copier, fax, and file drawer throughout the area for everyone to use (and wait on), consider placing these items together in a U shaped cell to minimize movement.

The “One Piece Flow” concept is a great tool for processing items such as quotes, bills, or mail pieces. For example, if four people must review a quote, and the first person processes 500 prior to moving to the second individual, and so on, the cycle time is going to be very long. Also, if the fourth person notices a mistake the other three missed, all 500 are bad and much labor was spent unnecessarily. Moving the piece in a flow of “one” or in small batches minimizes the error cost and reduces cycle time.

Service industries have a terrific opportunity to reduce waste. Sometimes it is simple and obvious, while other times it takes the same creativity as in the factory.