Process or Departments - Document Content and Managing the Process Approach

Q

QAMTY

#1
Hi

In managing Process approach, I find some issues
Why if the focus is process approach, why still
are departments mentioned.?
For example i have seen:
"Documents in charge of sales department" or document number related
to the Enginnering department.

Is it correct to mention departments names?
or is there some cases where should be mentioned?

Thanks for feeding me back
 
Elsmar Forum Sponsor

Howard Atkins

Forum Administrator
Staff member
Admin
#2
Re: Process or departments

I do not think that there is any problem.

The process approach covers activities of the company.
The use of a department is just a way of describing where the problem was found.
 
S

samsung

#3
Re: Process or departments

Agree with Howard. A process may cut through one or more departments where someone has to own the documents and it's normally the one who has greater share of responsibility within the process.
 
Q

QAMTY

#4
Re: Process or departments

Thanks Howard ans samsung

I see, but in this case:

Suppose I have the Engineering process, which process
is achieved by several departments (sales, Purchasing,etc)
then for Engineering documents numbering and owner,
Is it correct to refer:

The owner is the ENG process or department?
or for numbering, ENG code,
Use ENG code coming from the process or department?

Thanks for yoir help
 

John Broomfield

Staff member
Super Moderator
#5
Re: Process or departments

Thanks Howard ans samsung

I see, but in this case:

Suppose I have the Engineering process, which process
is achieved by several departments (sales, Purchasing,etc)
then for Engineering documents numbering and owner,
Is it correct to refer:

The owner is the ENG process or department?
or for numbering, ENG code,
Use ENG code coming from the process or department?

Thanks for yoir help
QAMTY,

Your process owner should be a person not a department. The process owner is the expert in how the cross-functional process works. I would however be surprised if the process owner for Engineering is not working in the engineering department.

By definition every process is cross-functional and will require the work of people in more than one department.

Agreed, departments are of limited value because the organization adds value through its processes but some disciplines (such as HR and QA) still find them useful.

ISO 9001 still refers to functions in 5.4.1 and this is an accurate reflection of the immature status of process management in most organizations.

John
 

qusys

Trusted Information Resource
#6
Hi

In managing Process approach, I find some issues
Why if the focus is process approach, why still
are departments mentioned.?
For example i have seen:
"Documents in charge of sales department" or document number related
to the Enginnering department.

Is it correct to mention departments names?
or is there some cases where should be mentioned?

Thanks for feeding me back
Hi QAMTY,
I think it can be correct and I see no issue for this.
Take into account the the clause of document control of ISO 9001 is a cross functional one and the organization , establishing a documented procedure, set its requirements ( meeting ISO standard), cascading them across all over the QMS processes. It is clear that each dept. will embody them in its own departmental procedures. Besides, I would also like say that there are some documents concerning with othe mgmt systems as well as legal aspects. These one could be related to some specific department for several reasons and you as organization can set this in the documented procedure of document control if you believe that they are part of your QMS.
Hope this helps:bigwave:
 

Pancho

wikineer
Super Moderator
#7
Re: Process or departments

ISO 9001 still refers to functions in 5.4.1 and this is an accurate reflection of the immature status of process management in most organizations.
:topic:

It's interesting that ISO 9000 defines most terms used in ISO 9001, but doesn't define "function". If having functions in an organization is a reflection of the immature status of process management, then why does ISO 9000 allow for a metrological function?

What is a function? How does it differ from a process? If we still need functions despite using the process approach, shouldn't they be at least defined in the standard?
 

John Broomfield

Staff member
Super Moderator
#8
Re: Process or departments

:topic:

It's interesting that ISO 9000 defines most terms used in ISO 9001, but doesn't define "function". If having functions in an organization is a reflection of the immature status of process management, then why does ISO 9000 allow for a metrological function?

What is a function? How does it differ from a process? If we still need functions despite using the process approach, shouldn't they be at least defined in the standard?
Pancho,

In organizational terms ISO 9001 specifies functions as departments or disciplines (also see 7.3.4).

I see no mention of functions in 7.6.

Process is the work whereas functions are the resources available (often in departments) to do the work.

John
 
A

ancys

#9
It is clear, for each department. Will be reflected in the departmental procedures. In addition, I would like to say, there are some file on Chant MGMT systems as well as legal.
 

Helmut Jilling

Auditor / Consultant
#10
Re: Process or departments

Thanks Howard ans samsung

I see, but in this case:

Suppose I have the Engineering process, which process
is achieved by several departments (sales, Purchasing,etc)
then for Engineering documents numbering and owner,
Is it correct to refer:

The owner is the ENG process or department?
or for numbering, ENG code,
Use ENG code coming from the process or department?

Thanks for yoir help
I think you are making this too complicated. You are correct, as you say -Several departments are involved in the Engineering process. But, look at it simply. They do not perform Engineering, they participate. Linkages.

For example, the purpose and function of the:

1. Sales Process is to get business, customers, orders. The primary activity is to interact with customers.

2. Engineering Process is to figure out how to do make that customer order, how to make it work well. The primary activity is to interact with their computer and the particpants in the program.

3. Purchasing Process is to acquire the materials and parts that Engineering specifies. The primary activity is to interact with suppliers.

And so on. I think you are confusing linkages with the process. Many processes and departments interact with Engineering, and share their expertise. But Engineering performs most of the process.
 
Thread starter Similar threads Forum Replies Date
T Ownership of Procedures where Multiple Departments are involved in the Process Process Maps, Process Mapping and Turtle Diagrams 12
S Depicting Communication Flow Gaps between Departments/Process Steps on a Process Map Process Maps, Process Mapping and Turtle Diagrams 1
R Involvement of several Departments in Contract Review Process Contract Review Process 12
S In-Process Check for Support Departments ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Process Owners and Process Documentation which Affects Multiple Departments Document Control Systems, Procedures, Forms and Templates 6
V Process Based Organization Chart that lists processes instead of departments? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 25
W Need for current design or process control FMEA and Control Plans 2
M Hiring Decisions - How much effort do you put into the hiring process these days? (7/2020) Misc. Quality Assurance and Business Systems Related Topics 4
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
A What is the difference between Design Process, Process Design and Design Control? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 7
C Refreshing an old and boring topic - Job descriptions and Roles vs Process Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
C OEE and In-process Inspection Manufacturing and Related Processes 2
S Effective nonconforming process for AS9100 8.7 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
T ISO 13485 - Process validation at critical suppliers ISO 13485:2016 - Medical Device Quality Management Systems 7
K Software Validation for Measurement Tools used in Process Validation ISO 13485:2016 - Medical Device Quality Management Systems 2
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Design verification driven by new equipment. How is this different than process validation? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
I Release checklist EO sterilization process Medical Device and FDA Regulations and Standards News 3
V Informational SMMT IATF Oversight - OEM KPI Process IATF 16949 - Automotive Quality Systems Standard 4
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
Stoic Are any medical device companies using the 2011 FDA process validation guidance instead of GHTF/SG3/N99-10:2004? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T Design Control Procedures later in the Development Process ISO 13485:2016 - Medical Device Quality Management Systems 6
K Process Mapping - Inputs/Outputs/Detail Activities/Control points/Measurement? Process Maps, Process Mapping and Turtle Diagrams 4
D Social Media Feedback process for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
P Images of Product for Automated Process - How long to keep? US Food and Drug Administration (FDA) 2
J Where to Place Process Maps in our Documentation? Process Maps, Process Mapping and Turtle Diagrams 4
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
B Supplier of design and manufacture process ISO 13485:2016 - Medical Device Quality Management Systems 10
D Calibration Process Flow Map Example Wanted General Measurement Device and Calibration Topics 3
G Devices from IQ, OQ or PQ process to be used for verification, validation and summative? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
A Design process goal for ISO 9001 Manufacturing and Related Processes 23
S Process Map for Supplier Process Maps, Process Mapping and Turtle Diagrams 5
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Procedure equals a process? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 25
J ISO 14001 revision process ISO 14001:2015 Specific Discussions 1
M What is the average time needed for process documentation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
M Process Creation Advice Needed Design and Development of Products and Processes 3
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
H Human Resources Process Document Control Systems, Procedures, Forms and Templates 2
R Process control documents - Context of API Spec Q1, Clause 5.7.1.3 Other ISO and International Standards and European Regulations 0
M MSDS process audit - Can any one give idea for checklist of the same Occupational Health & Safety Management Standards 14
A How to set up Continuous CpK monitoring of an injection mold process Reliability Analysis - Predictions, Testing and Standards 7
N Design Verification & Process Validation - Statistical sample sizes Design and Development of Products and Processes 2
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
J KPIs or Metrics to Measure a New Complaint Handling Process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Similar threads


















































Top Bottom