SurveyMonkey Powered Online Survey

Dear Colleagues,

Please answer the following questions. The results of this survey will be shown in the next Maas & Peither Newsletter LOGFILE.

We will, of course, ensure absolute anonymity for our participants. Thank you very much for your willingness to participate.

With kind regards,

Thomas Peither
President

Question Title

* 1. How is your Quality Management System structured?

According to GMP processes (e.g. analog EU-GMP-Guide)

According to ISO 9001:2000

According to ICH Q10 Pharmaceutical Quality Systems

Question Title

* 2. How many pages does your quality manual consist of?

50-100 pages

100-300 pages

300-500 pages

more than 500 pages

We don't have a quality manual.

Question Title

* 3. Does your quality manual cover the following topics?
(Select all which apply)

Management responsibility

Resource management

Management review

Change management

CAPA (Corrective action, preventive action)

Deviations

GMP Training

Supplier qualification

Product Quality Review

Handling of complaints and recalls

Question Title

* 4. Have you implemented the following tasks in separate functions/departments?
(Select all which apply)

Quality Management

Quality Assurance/Quality Unit

Quality Control

Question Title

* 5. Which quality tools are known, implemented or intended to be implemented in your company?

	Not known	Known	Implemented	Intended to be implemented within the next 2 years
SPC (Statistical Process Control)	SPC (Statistical Process Control) Not known	SPC (Statistical Process Control) Known	SPC (Statistical Process Control) Implemented	SPC (Statistical Process Control) Intended to be implemented within the next 2 years
Six Sigma	Six Sigma Not known	Six Sigma Known	Six Sigma Implemented	Six Sigma Intended to be implemented within the next 2 years
Quality by design	Quality by design Not known	Quality by design Known	Quality by design Implemented	Quality by design Intended to be implemented within the next 2 years
Kaizen	Kaizen Not known	Kaizen Known	Kaizen Implemented	Kaizen Intended to be implemented within the next 2 years
Ishikawa (Fish Bone Diagram)	Ishikawa (Fish Bone Diagram) Not known	Ishikawa (Fish Bone Diagram) Known	Ishikawa (Fish Bone Diagram) Implemented	Ishikawa (Fish Bone Diagram) Intended to be implemented within the next 2 years
FMEA (Failure Mode Effect Analysis)	FMEA (Failure Mode Effect Analysis) Not known	FMEA (Failure Mode Effect Analysis) Known	FMEA (Failure Mode Effect Analysis) Implemented	FMEA (Failure Mode Effect Analysis) Intended to be implemented within the next 2 years
PAT (Process Analytical Technology)	PAT (Process Analytical Technology) Not known	PAT (Process Analytical Technology) Known	PAT (Process Analytical Technology) Implemented	PAT (Process Analytical Technology) Intended to be implemented within the next 2 years

Question Title

* 1. How is your Quality Management System structured?

Question Title

* 2. How many pages does your quality manual consist of?

Question Title

* 3. Does your quality manual cover the following topics?(Select all which apply)

Question Title

* 4. Have you implemented the following tasks in separate functions/departments?(Select all which apply)

Question Title

* 5. Which quality tools are known, implemented or intended to be implemented in your company?

* 3. Does your quality manual cover the following topics?
(Select all which apply)

* 4. Have you implemented the following tasks in separate functions/departments?
(Select all which apply)