iso document writing training

QUALITY MANAGEMENT TRAINING PROGRAM

ISO ISO Document Document Writing Writing

ISO Document Writing Training2

ObjectivesProvide overview of the

documentation requirement of ISO 13485

Demonstrate procedure writing steps & tips

Share the proposed documentation system for InQpharm

QMS success & QMS success & effectiveness is effectiveness is

from and for ALLfrom and for ALL


Content….

Documentation Defined…..ISO 13485 Documentation

RequirementProcess ApproachProcedure Writing Documentation SystemQ & A


What ? •Term •Definition

•Document information and its supporting medium

•Procedure specified way to carry out an activity or a process (Note: Procedures can be documented or not)

•Quality Manual document specifying the QMS of an organization

•Record document stating results achieved or providing evidence of activities performed

•Specification document stating requirements


Why ? Communication of Information

for information transmission and communication.

Evidence of Conformity provision of evidence that what was

planned, has actually been done.

Knowledge Sharing to disseminate and preserve the

organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.


ISO 13485 ISO 13485

Documentation Documentation RequirementRequirement


4.0 Quality Management System

4.1 General Requirements Document, implement, maintain an

effective QMS. Identify processes, its application, Sequence & interaction Criteria & method for QMS control are effective Provide resources & information (refer section 6) Ensure MAI (refer section 8) Implement actions to achieve planned result &

maintain effectiveness Adequate control over outsourced processes.


4.2 Documentation requirements

4.2.1 General

The organization needs to document quality policy & quality objectives, quality manual. Documented Procedures as required (e.g design project,

order processing, purchasing, document control, internal audit, supplier management, customer complaints, training)

Documents (records) needed (e.g purchase orders, sales contracts, inspection records, design review notes, audit report, supplier contract etc.),

Any others as required by national or regional regulation Technical file (DMR) for each type of devices. The quantity, detail, and form of the documentation can

differ from one organization to another depending on size, type of activities, or complexity of processes.


4.2.2 Quality manual The quality manual describes; extent of QMS and exclusion with justification procedures (included/referenced) Business process map

4.2.3 Control of documents Written Procedure on documents control (that requires

procedures are legible, identified, reviewed, authorized, up-to-date, issued, distributed, and periodically updated)

Obsolete documents to be identified and protected from unintended use.

External origin Documents identified and controlled.

4.2.4 Control of records records to demonstrate/evidence QMS operation legible, and easy to identify and retrieve. Written procedure on records control (records are identified,

stored, protected, retrievable, and define their retention and disposal times.

Process Approach


What is What?• Process = A set of interrelated or

interacting activities which transforms inputs into outputs.

• Procedure = Specified way to carry out an activity or a process (may be documented)

• Product = Results of a process

• Effectiveness = Ability to achieve desired results.

• Efficiency = Measure of results achieved versus planned resources.


Process Training What is your Business?

Input – Process – Output


The Process

INPUT

Includes Resources

PROCESS

Set of interrelated or interacting processes

OUTPUT

Results of a Process

What is a Process?

“A set of interrelated or interacting activities which transform inputs into outputs.”


The Process

•ISO 13485:2003 stresses the importance to identify, implement, manage & maintain effectiveness of the whole processes in order to achieve the company objectives.

•Inputs and Outputs may include equipment, materials, components, energy, information & financial resources, among others.

INPUTs and OUTPUTs


Process then Procedure

1.1. You are the owner of a coffee shop.You are the owner of a coffee shop.

2.2. You require a PROCESS.You require a PROCESS.

3.3. Then you require a PROCEDURE for a cup of Then you require a PROCEDURE for a cup of Coffee.Coffee.

What are your inputs from the customer? What do you need for the coffee? How do you fill the order? What is the final product?

Some Questions you may wish to ask yourself (among others)

EXERCISE


Where does it fit In ?

What other processes are involved?

Effectiveness = Ability to achieve desired results.

Efficiency = Measure of results achieved versus planned resources.

FeedbackSpecification

Hot Water Coffee Dispatch

Purchasing

Inspection

Transport

Training

Planning

Release

Improvement

Monitoring

Process then Procedure EXERCISE


ORDER(Customer Input)

Cup

*Hot Water

Coffee

Sugar

Milk

Spoon

MANUFACTURE

Hold Cup

Add water

Add Coffee

Add Sugar

Add Milk

Stir

RECEIPT(Customer Feedback)

A Standard Cup of Coffee

Customer Feedback

Specification Instruction Product

*another procedure within our facility

MAKING a CUP of COFFEEProcedure (low detail)


ORDER(Customer Input)

1. 250 ml cup

2. *Hot Water

3. Standard Coffee

4. Brown Sugar

5. Full Cream Milk

6. Tea Spoon

MANUFACTURE

1. Hold Cup

2. Pour Water

3. 1 x tsp Coffee

4. 2 x tsp Sugar

5. Dash of Milk

6. Stir x 4

RECEIPT(Customer Feedback)

1. A Standard Cup of Coffee

2. At the Table

3. After Dinner

4. Customer Feedback form

WHAT ? HOW ? WHEN? WHERE ?

How Much Detail Is Required?

*another procedure within our facility

Procedure (high detail)


+ + +

+ + =

How Much Detail Is Required?Procedure (no detail)


Define the Process,

Detail the Training of operators,

Provide Resources, (tools etc)

Define Criteria/Methods to operate/control the

process,

Define how the Process will be Measured,

Define how the Performance will be

Monitored.

What Now?Managing The Process


Is your Procedure Effective?Is your Procedure Effective?

How do you Monitor it?How do you Monitor it?

How do you Measure it?How do you Measure it?

Can you Improve it?Can you Improve it?

Is It Effective? Can You Improve It?Monitoring The Process


NOT ALL

PROCES

SES

!!!!!

NOT ALL

PROCES

SES

!!!!!

NOT ALL PROCESSES !!!!!

Remember !Remember !


IDENTIFY INPUT, OUTPUT & OBJECTIVE METRIC ?


PROCEDURE PROCEDURE WRITINGWRITINGTT(techniques)(techniques) & & TT(tips)(tips)


ISO 9000 Procedure Writing Information

intent of the procedures are to be used as a reference where they will provide guidance and consistency when employees perform quality related tasks.

Responsibilities for Procedures: Each department must be responsible

for writing their procedures. Managers for the departments have

approval of all procedures under their areas of responsibility.




Requirements of Procedures: Procedures are to be of document

control. (numbered, revision, signed & dated)

Procedures should reference inner-related procedures and quality system documentation created from following the procedure.

Quality Records as required by the ISO standard that are generated by a procedure must be controlled (e.g by form control process


Procedures should specify: What should be done? Who will do it? When will it be done and in what

sequence? How will it be done? What equipment, tools or materials will be

used? What forms or other documents will be

used.? An appendix for all forms used in the

procedure A flow chart for the procedure (where

applicable the flow chart can be the procedure if it is understandable)


Procedures should specify: Signed, dated authorizations under revision

control with controlled distributions. Other considerations to incorporate in

procedures: Definitions Referencing standards Safety or danger warnings related to the

procedure Documentation Quality Records The Bottom Line:

For ISO, the bottom line is to write what you do, then do what you have written.


Tips on Procedures: 1: The more general the procedure, the more

flexible, however, the more specific the guidance, for those responsible for carrying out job duties, the easier the system is to maintain.

2: There must be at least one procedure for each element for the standard, dependant upon complexity of the element. Writing separate procedures for manageable activities will be less confusing than one grand activity.

3: A reference can be put into the procedures referencing other procedures if you are documenting the elements other than by the ISO Standard numbering scheme.


Tips on Procedures: 4: Try to keep the procedures from being to

specific. Assign who (by job title) does a task & when does it happen.

5: When assigning responsibility, use of designee of person responsible in the process will keep the process flexible & provide an option should the responsible person be unavailable at any specific time

6: Keep the use of symbols minimized. 7: There must be consistency in action. 8: Use of a flow chart is highly

recommended.


Avoid Drowning in Detail…..

“The purpose of this procedure is to document the aforementioned activities, herin after referred to as the prescribed tasks in terms that preclude their execution in an inconsistent manner, wherin such inconsistency may potentially result in the prescribed tasks delivering a result that is not repeatable or reproducible”


Make procedures user friendly

Use short sentences starting with a verb.

Avoid using the passive voice. Make it clear who is performing the task.

Use white space for easy reading.


DocumentationToo Much? Too Little? Too Much:

Work instructions written for virtually everything

Overlap and repetition - Including a process in more than one work instruction.

Too little: Lack of work instructions resulting in

inconsistent processes and quality of the product.


Documentation Remember that the goal here is

consistency for your processes. If two trained employees were to

perform this task, would they do it the same way?

If the answer to this is “Maybe not” a work instruction is appropriate.


Departments that are “Different”

Do you have a department that needs “artistic license” to do their work?

You may encounter some resistance to documenting procedures in these areas.


Help them see how the procedure can work for them.

It is important to demonstrate to these departments that the process should be consistent.

The creativity takes place within the process.

Document the procedure to describe the steps that must be followed, but not to prescribe the detail of their job.


QMSQMS

DOCUMENTATION DOCUMENTATION SYSTEM SYSTEM


Determine individual processes, input, output & objective metric (to be forwarded)

Establish work flow, write procedures, train and records (those mandatory for ISO, ready for review by end Aug 05 !)

Support QMS Ensure appropriate control, monitor &

improve Always in ready mode QMS success & QMS success &

effectiveness is effectiveness is from and for ALLfrom and for ALL


Q & AQ & A

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