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Main Subject - ISO 9001 - The Three Components of the Implementation Process
The three components to implementing an ISO 9001 quality management system are: 1) documentation, 2) information management, and 3) operational changes.
Documentation
On the surface it may seem like developing the ISO 9001 documentation shouldn’t be that difficult. You must have a manual that includes a policy, objectives, scope, and the interaction of the processes; and you must have written instructions for:
The standard also hints at
Documentation
On the surface it may seem like developing the ISO 9001 documentation shouldn’t be that difficult. You must have a manual that includes a policy, objectives, scope, and the interaction of the processes; and you must have written instructions for:
- Managing the quality system documents
- Managing the quality system records
- Conducting internal audits
- Controlling nonconforming product
- Implementing corrective action
- Implementing preventive action
The standard also hints at
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
the need for additional instructions, e.g., referring to the work instructions, section 7.1 states “shall determine the following, as appropriate,” but technically, aside from the manual and these six instructions, anything more is optional.
The reality, however, is that in order to get the most out of a quality management system a significant amount of additional documentation is required. A primary function of the system is to establish consistency and eliminate misunderstandings, which is best facilitated with clear and unambiguous written instructions. Policies, which are a pervasive part of any system, have absolutely no value if they're not in writing, and enforcing accountability is extremely difficult if the resp
The reality, however, is that in order to get the most out of a quality management system a significant amount of additional documentation is required. A primary function of the system is to establish consistency and eliminate misunderstandings, which is best facilitated with clear and unambiguous written instructions. Policies, which are a pervasive part of any system, have absolutely no value if they're not in writing, and enforcing accountability is extremely difficult if the resp
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
onsibilities are not spelled out.
The ISO 9001 system documentation is normally organized into four sections, including:
The ISO 9001 system documentation is normally organized into four sections, including:
- The Manual, which provides background information and explains how the system works;
- The Administrative Procedures, which include the procedures and policies that define how the company complies with the requirements of the standard and how it manages the processes that are unique to its operation;
- The Operating Instructions, which are the detailed instructions used to control manufacturing and service activities; and
- The Reference Documentation, which are documents like industry standards, equipment maintenance manuals, corporate auditing guidelines, employee policie
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
s, etc. that define practices, procedures, or performance criteria not covered by the other documents. These can either be externally or internally generated.
No two organizations have the same goals and objectives or do things exactly the same way, which means there are always some differences between the procedures and policies of different organizations. It also means that completely documented “off-the-shelf” systems don’t exist and some document development is inevitable. The challenge is to minimize the effort without sacrificing value.
The Manual – The administrative procedures are usually the more difficult and time-consuming of the four sections to develop. The manual, on the other ha
No two organizations have the same goals and objectives or do things exactly the same way, which means there are always some differences between the procedures and policies of different organizations. It also means that completely documented “off-the-shelf” systems don’t exist and some document development is inevitable. The challenge is to minimize the effort without sacrificing value.
The Manual – The administrative procedures are usually the more difficult and time-consuming of the four sections to develop. The manual, on the other ha
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
nd, is relatively straightforward and probably the easiest part to develop. The standard suggests what should be included, and an example of a “well written” manual can provide the format for organizing the material. Most of the work is in converting the ideas of the example into documents that describe your situation. Goals and objectives have to be established, processes defined, responsibilities established, the interaction of the processes explained, and the system parameters established.
Administrative Procedures – The secret to developing administrative procedures is 1) using a format that creates readable documents, 2) finding examples of procedures that offer solutions that apply to your needs, a
Administrative Procedures – The secret to developing administrative procedures is 1) using a format that creates readable documents, 2) finding examples of procedures that offer solutions that apply to your needs, a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
nd 3) organizing the documentation based a process list.
The “process approach” is the system structure recommended by the authors of the standard and the process list is the starting point of the process approach.
Think of processes as objectives, i.e., maximizing employee output, making sure new products comply with customer requirements, or making sure working conditions adequately support the production objectives. A set of procedures that constitute a means for meeting an objective is what the standard refers to as an “activity group”. Employee vetting, performance reviews, and training procedures is an examples of an activity group that maximizes employee output. The objectives are the outputs of the “process appr
The “process approach” is the system structure recommended by the authors of the standard and the process list is the starting point of the process approach.
Think of processes as objectives, i.e., maximizing employee output, making sure new products comply with customer requirements, or making sure working conditions adequately support the production objectives. A set of procedures that constitute a means for meeting an objective is what the standard refers to as an “activity group”. Employee vetting, performance reviews, and training procedures is an examples of an activity group that maximizes employee output. The objectives are the outputs of the “process appr
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
oach” and the procedures (the activity groups) the inputs. Example:
The format used for developing the procedures, to a large extent, determines whether employees will embrace the system. It can be the difference between documents that are easy to read and ones t
Input = Policies and procedures for making sure employees are motivated, informed, and capable of performing the assigned responsibilities
Output = Maximum employee outputThe process list is simply a list of those objectives that best represent the needs of your organization. They can be different for every organization and are rarely in sync with the outline of the standard.
The format used for developing the procedures, to a large extent, determines whether employees will embrace the system. It can be the difference between documents that are easy to read and ones t
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
hat are not. The better formats include a clear propose, policies that are relevant to the purpose, and an explanation why things are done the way they are done. A good format also leaves no doubt as to who is accountable for the actions of the procedures.
Examples of procedures from other systems provide ideas on how to develop new procedures and how to improve existing procedures. The same examples can also provide formatting ideas. Don’t fall into the trap of thinking that there must be a procedure of every requirement of the standard, or that the documentation has to follow the outline of the standard. The authors of the standard have made it clear that this is not the case. You are encouraged to use a process approa
Examples of procedures from other systems provide ideas on how to develop new procedures and how to improve existing procedures. The same examples can also provide formatting ideas. Don’t fall into the trap of thinking that there must be a procedure of every requirement of the standard, or that the documentation has to follow the outline of the standard. The authors of the standard have made it clear that this is not the case. You are encouraged to use a process approa
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ch, which is inherently unique to your operation, and to include processes that are important to you but may not included in the standard.
While individual examples can be helpful, continuous system templates that lock into the outline of the standard tend to complicate the implementation process. They depersonalize the system, limit the system to the scope of the standard, and make the process of writing procedures more difficult. Also, don’t go overboard on process mapping and flowcharting. Procedures should be clear to everybody, not just the primary users. A fundamental covenant of the system is continual improvement and some of best improvement ideas come from employees with unrelated responsibilities.
Oper
While individual examples can be helpful, continuous system templates that lock into the outline of the standard tend to complicate the implementation process. They depersonalize the system, limit the system to the scope of the standard, and make the process of writing procedures more difficult. Also, don’t go overboard on process mapping and flowcharting. Procedures should be clear to everybody, not just the primary users. A fundamental covenant of the system is continual improvement and some of best improvement ideas come from employees with unrelated responsibilities.
Oper
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ating Procedures – The trick to developing operating procedures is in understanding the balance between training and documentation requirements, and in knowing how much information is needed. Too many companies develop too much unnecessary detail.
The standard requires employers to provide employees with the information needed to correctly perform their assigned responsibilities. Proof is either documentation showing that they have been provided the necessary instructions, or training records, which also verifies that they have been provided the necessary instructions. The value of written operating instructions is that they make it easier to hold employees accountable for their actions. From this standpoint, it
The standard requires employers to provide employees with the information needed to correctly perform their assigned responsibilities. Proof is either documentation showing that they have been provided the necessary instructions, or training records, which also verifies that they have been provided the necessary instructions. The value of written operating instructions is that they make it easier to hold employees accountable for their actions. From this standpoint, it
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
is only necessary to document those aspects of an operation that are subject to misinterpretation or misunderstanding, which normally doesn’t require a great deal of detail.
Information Management
Managing information is a big part of the standard. The standard states that records shall be maintained in the case of management review meeting minutes (5.6.1); education, training, skills and experience (6.2.2); product validation and verification (7.1.d); inputs for product design and development (7.3.2); and calibration records (7.6). In addition, the standard also requires “evidence of conformity”, which is either physical evidence or documented records, and in many cases records are preferable
Information Management
Managing information is a big part of the standard. The standard states that records shall be maintained in the case of management review meeting minutes (5.6.1); education, training, skills and experience (6.2.2); product validation and verification (7.1.d); inputs for product design and development (7.3.2); and calibration records (7.6). In addition, the standard also requires “evidence of conformity”, which is either physical evidence or documented records, and in many cases records are preferable
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
and sometimes the only alternative.
Records provide a means of confirming that the quality system is controlled, customer requirements are understood, audits are conducted, customers are heard, problems are found and corrected, non-conforming goods are managed, purchasing information is correct, products are traceable, and incoming goods are inspected.
The method of managing information is generally some combination of 1) a file management program, 2) database files such as Microsoft Access, or 3) hard copy files, i.e., binders, file cabinets and manila folders, all of which have advantages and disadvantages.
File Management Programs – File management programs are typically tamper-proof and capable of
Records provide a means of confirming that the quality system is controlled, customer requirements are understood, audits are conducted, customers are heard, problems are found and corrected, non-conforming goods are managed, purchasing information is correct, products are traceable, and incoming goods are inspected.
The method of managing information is generally some combination of 1) a file management program, 2) database files such as Microsoft Access, or 3) hard copy files, i.e., binders, file cabinets and manila folders, all of which have advantages and disadvantages.
File Management Programs – File management programs are typically tamper-proof and capable of
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
handling a large volume of information. They’re designed to be paperless systems. Assignments, authorization levels, and additions and revisions to records are keyed into the program, which, under certain conditions, trigger action commands that are communicated via email. There are a few programs tailored to manage primarily ISO 9000 records, but most are universal in nature and designed to manage all types of records. The user is normally responsible for developing the forms and reports needed to manage specific types of records.
The programs are expensive; they come with annual and sometimes monthly maintenance fees; and there are usually costs associated with installation, the number of users, data migration, and tr
The programs are expensive; they come with annual and sometimes monthly maintenance fees; and there are usually costs associated with installation, the number of users, data migration, and tr
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
aining. Many have their own programming language, which makes the user dependent on people with that language skill. And some are web based, which means the program is running on someone else’s server. Generally, they are best suited for companies with a lot of people dealing with a large volume of information.
Database Files – Database files are less expensive, more flexible, and easier to manage. You can either develop your own files or purchase files that have been programmed to deal with specific types of records.
The majority use Microsoft Access and run on a Microsoft Windows operating system. The cost is the cost of the files plus the cost of the Microsoft programs. (The 9000 Advisers offer indiv
Database Files – Database files are less expensive, more flexible, and easier to manage. You can either develop your own files or purchase files that have been programmed to deal with specific types of records.
The majority use Microsoft Access and run on a Microsoft Windows operating system. The cost is the cost of the files plus the cost of the Microsoft programs. (The 9000 Advisers offer indiv
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
idual Access files for all the ISO 9001 record keeping requirements.) The files are placed on a server and secured by whatever means is used to secure the server files. Changes and enhancements can be made by anyone who understands Microsoft Access. In most cases there are no user fees or reoccurring maintenance fees, and existing database files can be transferred into the files with the migration functions of the Access program.
Hard Copy Records – Almost everyone ends up with some hard copy records: documents that can’t be scanned, documents with signatures, and documents that are available to all employees. However, building a record keeping policy completely around this approach is risky, even for sm
Hard Copy Records – Almost everyone ends up with some hard copy records: documents that can’t be scanned, documents with signatures, and documents that are available to all employees. However, building a record keeping policy completely around this approach is risky, even for sm
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
all companies. It is too easy to misplace documents that move from one person to the next; and it is difficult to manage information that is located in various files, in different offices, and assigned to different people. Responsibilities change and individuals tend to change the way information is gathered and filed. Manual record keeping frequently results in unnecessary duplication, e.g., sales using a different customer list than the person keeping track of the customer complaints. It is also difficult to gather, analyze, and disseminate information. File cabinets are not as accessible as computers and don’t have the sorting, reporting, linking and analytical capabilities of database files.
Operational C
Operational C
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
hanges
The final component of the implementation process is the operational changes, which are the changes needed in order to meet the procedural requirements of a system. They include both the things that are done in order to ensure that the products and services comply with the requirements specified by the customer, as well as the measure taken to in order to improve products and services and the processes used to produce the products and services.
Some of the more common ones include:
The final component of the implementation process is the operational changes, which are the changes needed in order to meet the procedural requirements of a system. They include both the things that are done in order to ensure that the products and services comply with the requirements specified by the customer, as well as the measure taken to in order to improve products and services and the processes used to produce the products and services.
Some of the more common ones include:
Administration – 1) Conduct at least one management review meeting. 2) Communicate system developments to all employees. 3) Demonstrate that the key performance indicators are measured, evalu
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ated, and communicated.
ISO Representative – 1) Make sure that the auditors are adequately trained. 2) Develop an audit schedule and conduct audits on all of the system procedures. 3) Demonstrate that the corrective and preventive action processes are working. 4) Make system procedures and forms available to employees.
Human Resources –1) Verify that all employees have a basic understanding of the ISO 9000 system. 2) Prove that all employees are capable of performing their respective work assignments, including the top-level executives. 2) Establish a training program for developing employee skills.
Purchasing – 1) Demonstrate that all of the primary vendors are qualif
ISO Representative – 1) Make sure that the auditors are adequately trained. 2) Develop an audit schedule and conduct audits on all of the system procedures. 3) Demonstrate that the corrective and preventive action processes are working. 4) Make system procedures and forms available to employees.
Human Resources –1) Verify that all employees have a basic understanding of the ISO 9000 system. 2) Prove that all employees are capable of performing their respective work assignments, including the top-level executives. 2) Establish a training program for developing employee skills.
Purchasing – 1) Demonstrate that all of the primary vendors are qualif
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
ied and that their performance is routinely evaluated. 2) Prove that material specifications are verified before they are released to vendors.
Sales/Customer Service – 1) Demonstrate that customer feedback is gathered and analyzed, including records of complaints. 2) Prove that processing capabilities are reviewed before orders for new products are confirmed.
Engineering – 1) Demonstrate that the information released to production is current, accurate, and complies with customer requirements. 2) Demonstrate that product changes affecting form, fit, or function are not implemented without customer approval.
Production – 1) Establish a calibration program that complies w
Sales/Customer Service – 1) Demonstrate that customer feedback is gathered and analyzed, including records of complaints. 2) Prove that processing capabilities are reviewed before orders for new products are confirmed.
Engineering – 1) Demonstrate that the information released to production is current, accurate, and complies with customer requirements. 2) Demonstrate that product changes affecting form, fit, or function are not implemented without customer approval.
Production – 1) Establish a calibration program that complies w
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ith the requirements of the standard. 2) Demonstrate that machinery capabilities have been validated. 3) Prove that nonconforming materials are not mixed in with satisfactory materials. 4) Prove that that shipments comply with the customer requirements. 5) Prove that incoming materials comply with purchase specifications. 6) Prove that operators are provided with the information required to produce products that conform to customer requirements. 7) Demonstrate how materials with shelf life are managed.
System documentation and information management are the paperwork part of the system. The operational changes are the action part and represent the part of the implementation process that makes the system work
System documentation and information management are the paperwork part of the system. The operational changes are the action part and represent the part of the implementation process that makes the system work
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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